AVDL Avadel Pharmaceuticals plc

8.78
0  0%
Previous Close 8.78
Open 8.79
52 Week Low 4.83
52 Week High 13.49
Market Cap $513,324,026
Shares 58,465,151
Float 57,040,923
Enterprise Value $422,451,025
Volume 161,427
Av. Daily Volume 581,974
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Upcoming Catalysts

Drug Stage Catalyst Date
FT 218
Excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy
PDUFA
PDUFA
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Drug Pipeline

Drug Stage Notes
AV001
Neonate Patients Requiring Total Parental Nutrition (TPN)
Approved
Approved
FDA Approval announced December 16, 2019.
VAZCULEP (phenylephrine hydrochloride)
Clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia
Approved
Approved
Approved June 30 2014.
Bloxiverz (neostigmine methylsulfate)
Reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery
Approved
Approved
Approved Jun 3 2013
Akovaz
Hypotension
Approved
Approved
Announced approval May 2 2016
Bloxiverz (neostigmine methylsulfate)
Reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery
Approved
Approved
Approved June 3, 2013.

Latest News

  1. DUBLIN, Ireland, April 08, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in adults with narcolepsy, today announced that it is scheduled to present new secondary endpoint data from its pivotal REST-ON Phase 3 trial at the 2021 American Academy of Neurology (AAN) Annual Meeting, which is being held virtually from April 17-22, 2021.

    Abstracts selected for presentation are summarized below.

    Poster Presentations
    Title: Polysomnographic Measures of Sleep Continuity in Patients with Narcolepsy: Results From the REST-ON Trial, a Pivotal Phase 3 Study of FT218, a Once-Nightly…

    DUBLIN, Ireland, April 08, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in adults with narcolepsy, today announced that it is scheduled to present new secondary endpoint data from its pivotal REST-ON Phase 3 trial at the 2021 American Academy of Neurology (AAN) Annual Meeting, which is being held virtually from April 17-22, 2021.

    Abstracts selected for presentation are summarized below.

    Poster Presentations

    Title: Polysomnographic Measures of Sleep Continuity in Patients with Narcolepsy: Results From the REST-ON Trial, a Pivotal Phase 3 Study of FT218, a Once-Nightly Sodium Oxybate Formulation

    Presenter: Yves Dauvilliers, M.D., Ph.D., University of Montpellier

    Available: April 17, 2021

    Title: Daytime Sleepiness, Sleep Quality, Hallucinations, and Sleep Paralysis in Patients with Narcolepsy: Results From the REST-ON Trial, a Pivotal Phase 3 Study of FT218, a Once-Nightly Sodium Oxybate Formulation

    Presenter: Michael J. Thorpy, M.D., Albert Einstein College of Medicine

    Available: April 17, 2021

    To register, visit AAN's website: www.aan.com/conferences-community/annual-meeting.

    About Avadel Pharmaceuticals plc:

    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is a biopharmaceutical company primarily focused on the development and FDA approval of FT218, an investigational, once-nightly, extended-release formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy. For more information, please visit www.avadel.com.

    About FT218

    FT218 is an investigational, once-nightly formulation of sodium oxybate that includes Avadel's MicroPump™ controlled-release (CR) technology. In March of 2020, the Company completed the REST-ON study, a pivotal, double-blind, randomized, placebo-controlled Phase 3 trial, to assess the efficacy and safety of FT218 in the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. In December 2020, the Company submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for FT218 to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy. The NDA for FT218 was accepted by the FDA in February 2021 and assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 15, 2021. FT218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy. The designation was granted on the plausible hypothesis that FT218 may be clinically superior to the twice-nightly formulation of sodium oxybate already approved by the FDA for the same indication. In particular, FT218 may be safer due to ramifications associated with the dosing regimen of the previously approved product.

    Contacts:

    Investor Contacts

    Tom McHugh

    Chief Financial Officer

    Phone: (636) 449-1843

    Email:

            

    Tim McCarthy

    LifeSci Advisors, LLC

    Phone: (212) 915.2564

    Email:

    Media Contact

    Patrick Bursey

    LifeSci Communications, LLC

    Phone: (646) 970-4688

    Email:



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  2. DUBLIN, Ireland, March 18, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in adults with narcolepsy, announced today that members of the Avadel management team will participate in a fireside chat at Stifel's Third Annual CNS Day, which is being held on March 31st.

    Avadel's fireside chat is scheduled for 3 p.m. ET on Wednesday, March 31st. A live webcast of this event, as well as an archived recording, will be available at (click here), as well as on Avadel's website, www.avadel.com, for 90 days from being made available.

    Contacts:

            Tom McHugh
            Chief…

    DUBLIN, Ireland, March 18, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in adults with narcolepsy, announced today that members of the Avadel management team will participate in a fireside chat at Stifel's Third Annual CNS Day, which is being held on March 31st.

    Avadel's fireside chat is scheduled for 3 p.m. ET on Wednesday, March 31st. A live webcast of this event, as well as an archived recording, will be available at (click here), as well as on Avadel's website, www.avadel.com, for 90 days from being made available.

    Contacts:

            Tom McHugh

            Chief Financial Officer

            Phone: (636) 449-1843

            Email:

            

            Tim McCarthy

            LifeSci Advisors, LLC

            Phone: (212) 915-2564

            Email:



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    • New Drug Application (NDA) for once-nightly FT218 to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy accepted for filing by the FDA; assigned a Prescription Drug User Fee Act (PDUFA) target date of October 15, 2021
    • Completed key appointments for Commercial, Clinical and Medical Affairs functions to lead launch planning and readiness to capitalize on significant market opportunity
    • Presenting new data highlighting the overall clinical value proposition of FT218 at upcoming medical congresses and key publications
    • Management to host a conference call today at 8:30 a.m. ET

    DUBLIN, Ireland, March 09, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational…

    • New Drug Application (NDA) for once-nightly FT218 to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy accepted for filing by the FDA; assigned a Prescription Drug User Fee Act (PDUFA) target date of October 15, 2021

    • Completed key appointments for Commercial, Clinical and Medical Affairs functions to lead launch planning and readiness to capitalize on significant market opportunity
    • Presenting new data highlighting the overall clinical value proposition of FT218 at upcoming medical congresses and key publications
    • Management to host a conference call today at 8:30 a.m. ET

    DUBLIN, Ireland, March 09, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy, today provided a corporate update and announced its financial results for the fourth quarter and year ended December 31, 2020.

    "We are pleased with the significant and rapid progress we have made on a number of fronts with our once nightly FT218 program including clinical research, market opportunity assessment, launch preparation, and our regulatory filing strategy. In less than 10 months, we have delivered exceptional top line results, an NDA submission and now formal FDA acceptance for review of our once-nightly FT218 NDA," said Greg Divis, Chief Executive Officer of Avadel.

    Mr. Divis continued, "Our priorities between now and a launch of FT218, if approved, are very clear: the execution of our NDA filing strategy and subsequent approval; the acceleration of our launch readiness; and the externalization of our pivotal data and related market preparation activities. We believe Avadel is well positioned to bring FT218 to patients suffering from narcolepsy and potentially command a market leading share of this multi-billion-dollar opportunity."

    Fourth quarter and recent company highlights

    • The NDA for FT218 was accepted for filing by the FDA and assigned a PDUFA target action date of October 15, 2021
    • Appointed Richard Kim as Chief Commercial Officer to lead the commercial strategy and launch of FT218, if approved
    • Appointed Dr. Jennifer Gudeman as Vice President, Medical and Clinical Affairs, leading the Company's medical and clinical affairs activities
    • Scheduled to present data from our REST-ON trial at the American Academy of Neurology in April 2021 and at SLEEP in June 2021, including all three primary endpoints, as well as a number of secondary endpoints and post-hoc analyses
    • To highlight the novel technology and predictable PK profile of FT218, four of the clinically relevant Phase 1 PK studies were recently described in a Clinical Therapeutics publication, "Pharmacokinetics of FT218, a Once-Nightly Sodium Oxybate Formulation in Healthy Adults"
    • Ongoing analysis of an internal comprehensive market assessment has provided key insights about the narcolepsy market and once nightly therapy, including:
      • Once-nightly FT218, if approved, is expected to be the preferred oxybate of choice based on results from large quantitative HCP and patient research projects
      • Oxybate eligible patients ranked a once-nightly therapy as being the most important driver of treatment preference
      • A once-nightly therapy was characterized by patients as increasing the likelihood of compliance and reducing stress and anxiety associated with the middle of the night dosing
      • Oxybate market expansion potential could benefit once-nightly FT218 due to patients and HCPs reported dosing challenges associated with the twice nightly treatment regimen of currently available oxybate products
    • Continued the expansion and enrollment of the RESTORE open-label extension/switch study of FT218 designed to generate long-term safety, tolerability, and efficacy data, as well as data on switching from twice-nightly sodium oxybate and patient preference

    Overview of Fourth Quarter Results

    As a result of the sale of the sterile injectable products to Exela Sterile Medicines LLC on June 30, 2020, the Company did not report any revenue for the fourth quarter of 2020, compared to $11.0 million in the fourth quarter of 2019.

    R&D expenses were $5.3 million in the fourth quarter of 2020, compared to $7.8 million in the fourth quarter of 2019. The decrease on a year-over-year basis was primarily attributed to the completion of the Phase 3 REST-ON clinical study for FT218, which concluded during the first quarter of 2020, as well as lower headcount due to the restructuring activities initiated during 2019.

    SG&A expenses were $9.0 million in the fourth quarter of 2020, compared to $7.7 million in the fourth quarter of 2019. The year-over-year increase is the result of a number of factors including FT218 NDA preparation and submission costs, commercial launch planning costs related to FT218 and higher stock-based compensation.

    Net loss for the fourth quarter of 2020 was $11.3 million, or ($0.19) per diluted share, compared to a net loss of $2.7 million, or ($0.07) per diluted share, for the same period in 2019. The increase in net loss and diluted loss per share is primarily the result of the year-over-year decrease in revenue due to the sale of the sterile injectable products partially offset by lower operating expenses. The increase in diluted shares outstanding resulted primarily from equity issuances related to financing activities completed during the first half of the year.

    Cash, cash equivalents and marketable securities were $221.4 million as of December 31, 2020. The Company has convertible debt of $143.8 million due in February 2023.

    Conference Call:

    A conference call to discuss these results has been scheduled for Tuesday, March 9, 2021 at 8:30 a.m. ET. To access the conference call, investors are invited to dial (877) 407-9716 (U.S. and Canada) or (201) 493-6779 (International). The conference ID number is 13716363. A live audio webcast can be accessed by visiting the investor relations section of the Company's website, www.avadel.com. A replay of the webcast will be archived on Avadel's website for 90 days following the event.

    About FT218

    FT218 is an investigational, once-nightly formulation of sodium oxybate that includes Avadel's MicroPump™ controlled-release (CR) technology. In March of 2020, the Company completed the REST-ON study, a pivotal, double-blind, randomized, placebo-controlled Phase 3 trial, to assess the efficacy and safety of FT218 in the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. In December 2020, the Company submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for FT218 to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy. The NDA for FT218 was accepted by the FDA in February 2021 and assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 15, 2021. FT218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy. The designation was granted on the plausible hypothesis that FT218 may be clinically superior to the twice-nightly formulation of sodium oxybate already approved by the FDA for the same indication. In particular, FT218 may be safer due to ramifications associated with the dosing regimen of the previously approved product.

    About Avadel Pharmaceuticals plc

    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is a biopharmaceutical company primarily focused on the development and FDA approval of FT218, an investigational, once-nightly, extended-release formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy. For more information, please visit www.avadel.com.

    Cautionary Disclosure Regarding Forward-Looking Statements

    This press release includes "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements relate to our future expectations, beliefs, plans, strategies, objectives, results, conditions, financial performance, prospects, or other events. Such forward-looking statements include, but are not limited to, the FDA's review of the NDA for FT218, the sufficiency of data supporting the NDA for FT218, the commercial launch of FT218 (if approved), and the market acceptance of FT218 (if approved). In some cases, forward-looking statements can be identified by the use of words such as "will," "may," "could," "believe," "expect," "look forward," "on track," "guidance," "anticipate," "estimate," "project," "next steps" and similar expressions, and the negatives thereof (if applicable).

    Our forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, our business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results and the results of our business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in our forward-looking statements include the risk that the NDA for FT218 is not approved by the FDA or such approval is delayed, the risk that FT218 (if approved) may not receive a 7-year Orphan Drug Exclusivity, the risk that the RESTORE study may be delayed or may not be completed at all, the risk that commercial launch of FT218 (if approved) is delayed, the risk that the potential market performance for FT218 (if approved) may differ materially from projections, and the risk that the impact of the current COVID-19 pandemic on our financial results and results of operations could be greater than we anticipate and the risks and uncertainties described in the "Risk Factors" section of Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2019, which we filed with the Securities and Exchange Commission (SEC) on March 16, 2020 and subsequent SEC filings.

    Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. We do not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law.

    Contacts:

    Investor Contacts

    Tom McHugh

    Chief Financial Officer

    Phone: (636) 449-1843

    Email:

    Tim McCarthy

    LifeSci Advisors, LLC

    Phone: (212) 915.2564

    Email:

    Media Contact

    Patrick Bursey

    LifeSci Communications, LLC

    Phone: (646) 970-4688

    Email:





    AVADEL PHARMACEUTICALS PLC


    UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF (LOSS) INCOME

    (In thousands, except per share data)

     Three Months Ended December 31, Twelve Months Ended December 31,
     2020 2019 2020 2019
            
    Product sales$  $10,995  $22,334  $59,215 
    Operating expenses:       
    Cost of products  2,414  5,742  12,125 
    Research and development expenses5,286  7,757  20,442  32,917 
    Selling, general and administrative expenses8,974  7,663  32,405  30,183 
    Intangible asset amortization  206  406  816 
    Changes in fair value of contingent consideration  (1,539) 3,327  845 
    Gain on sale of Hospital Products    (45,760)  
    Restructuring costs (income)  1,841  (43) 6,441 
    Total operating expenses14,260  18,342  16,519  83,327 
    Operating (loss) income(14,260) (7,347) 5,815  (24,112)
    Investment and other income (expense), net74  (1,479) (832) 1,069 
    Interest expense(3,308) (3,190) (12,994) (12,483)
    Gain from release of certain liabilities3,364    3,364   
    Gain (loss) on deconsolidation of subsidiary  162    (2,678)
    Other income (expense) - changes in fair value of contingent consideration payable  118  (435) (378)
    Loss before income taxes(14,130) (11,736) (5,082) (38,582)
    Income tax benefit(2,852) (8,997) (12,110) (5,356)
    Net (loss) income$(11,278) $(2,739) $7,028  $(33,226)
            
    Net loss (income) per share - basic$(0.19) $(0.07) $0.13  $(0.89)
    Net loss (income) per share - diluted(0.19) (0.07) 0.13  (0.89)
            
    Weighted average number of shares outstanding - basic58,325  37,465  52,996  37,403 
    Weighted average number of shares outstanding - diluted58,325  37,465  54,941  37,403 
            



    AVADEL PHARMACEUTICALS PLC


    UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS

    (In thousands, except per share data)

     December 31, 2020 December 31, 2019
        
    ASSETS   
    Current assets:   
    Cash and cash equivalents$71,722  $9,774 
    Marketable securities149,680  54,384 
    Accounts receivable  8,281 
    Inventories, net  3,570 
    Research and development tax credit receivable3,326  2,107 
    Prepaid expenses and other current assets38,726  4,264 
    Total current assets263,454  82,380 
    Property and equipment, net359  544 
    Operating lease right-of-use assets2,604  3,612 
    Goodwill16,836  18,491 
    Intangible assets, net  813 
    Research and development tax credit receivable3,445  6,322 
    Other non-current assets24,939  39,274 
    Total assets$311,637  $151,436 
        
    LIABILITIES AND SHAREHOLDERS' EQUITY (DEFICIT)   
    Current liabilities:   
    Current portion of long-term contingent consideration payable$  $5,554 
    Current portion of operating lease liability474  645 
    Accounts payable2,934  6,100 
    Accrued expenses6,501  19,810 
    Other current liabilities5,200  3,875 
    Total current liabilities15,109  35,984 
    Long-term debt128,210  121,686 
    Long-term contingent consideration payable, less current portion  11,773 
    Long-term operating lease liability1,840  2,319 
    Other non-current liabilities4,212  8,873 
    Total liabilities149,371  180,635 
        
    Shareholders' equity (deficit):   
    Preferred shares, nominal value of $0.01 per share; 50,000 shares authorized; 488 issued and outstanding at December 31, 2020 and 0 issued and outstanding at December 31, 20195   
    Ordinary shares, nominal value of $0.01 per share; 500,000 shares authorized; 58,396 issued and outstanding at December 31, 2020, and 42,927 issued and 37,520 outstanding at December 31, 2019583  429 
    Treasury shares, at cost, 0 and 5,407 shares held at December 31, 2020 and December 31, 2019, respectively  (49,998)
    Additional paid-in capital566,916  434,391 
    Accumulated deficit(384,187) (391,215)
    Accumulated other comprehensive loss(21,051) (22,806)
    Total shareholders' equity (deficit)162,266  (29,199)
    Total liabilities and shareholders' equity (deficit)$311,637  $151,436 
            



    AVADEL PHARMACEUTICALS PLC


    UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

    (In thousands)

     Twelve Months Ended December 31,
     2020 2019
        
    Cash flows from operating activities:   
    Net income (loss)$7,028  $(33,226)
    Adjustments to reconcile net income (loss) to net cash used in operating activities:   
    Depreciation and amortization1,690  2,486 
    Remeasurement of acquisition-related contingent consideration3,327  845 
    Remeasurement of financing-related contingent consideration435  378 
    Amortization of debt discount and debt issuance costs6,524  5,995 
    Changes in deferred tax(7,431) (6,334)
    Share-based compensation expense2,999  519 
    Gain on the disposition of the Hospital Products(45,760)  
    Loss on deconsolidation of subsidiary  1,750 
    Gain from the release of certain liabilities(3,364)  
    Other adjustments142  (254)
    Net changes in assets and liabilities   
    Accounts receivable8,281  2,471 
    Inventories, net(1,352) 1,155 
    Prepaid expenses and other current assets1,863  (1,187)
    Research and development tax credit receivable2,213  (1,014)
    Accounts payable & other current liabilities(2,788) 4,641 
    Deferred revenue  (114)
    Accrued expenses(13,226) 357 
    Earn-out payments for contingent consideration in excess of acquisition-date fair value(5,323) (10,988)
    Royalty payments for contingent consideration payable in excess of original fair value(866) (1,748)
    Other assets and liabilities(3,126) (4,057)
    Net cash used in operating activities(48,734) (38,325)
        
    Cash flows from investing activities:   
    Purchases of property and equipment(98) (29)
    Proceeds from disposal of property and equipment  154 
    Proceeds from the disposition of the Hospital Products25,500   
    Proceeds from sales of marketable securities36,284  63,246 
    Purchases of marketable securities(131,407) (24,648)
    Net cash (used in) provided by investing activities(69,721) 38,723 
        
    Cash flows from financing activities:   
    Proceeds from the February 2020 private placement60,570   
    Proceeds from the May 2020 public offering116,924   
    Proceeds from issuance of ordinary shares2,189  118 
    Other financing activities, net  (145)
    Net cash provided by (used in) financing activities179,683  (27)
    Effect of foreign currency exchange rate changes on cash and cash equivalents720  78 
    Net change in cash and cash equivalents61,948  449 
    Cash and cash equivalents at January 19,774  9,325 
    Cash and cash equivalents at December 31$71,722  $9,774 
            



    AVADEL PHARMACEUTICALS PLC


    UNAUDITED SUPPLEMENTAL INFORMATION

    (In thousands, except per share data)

      Three Months Ended December 31, Twelve Months Ended December 31,
    Revenues by Product: 2020 2019 2020 2019
             
    Bloxiverz $  $1,087  $2,201  $7,479 
    Vazculep   5,483  10,429  33,152 
    Akovaz   4,696  9,545  18,642 
    Other   (271) 159  (58)
    Product sales $  $10,995  $22,334  $59,215 



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  3. DUBLIN, Ireland, March 04, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy, today announced that it entered into an exclusive collaboration with the American Academy of Sleep Medicine Foundation (AASM Foundation) to support its 2021 Young Investigators Research Forum. The forum, taking place virtually through August, will provide scholarships and research training to 24 early career sleep medicine researchers.

    The Young Investigators Research Forum is a unique annual training program that was first launched in 2009, and it provides intense…

    DUBLIN, Ireland, March 04, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy, today announced that it entered into an exclusive collaboration with the American Academy of Sleep Medicine Foundation (AASM Foundation) to support its 2021 Young Investigators Research Forum. The forum, taking place virtually through August, will provide scholarships and research training to 24 early career sleep medicine researchers.

    The Young Investigators Research Forum is a unique annual training program that was first launched in 2009, and it provides intense career-building and networking opportunities for top sleep investigators in the U.S. who are starting their careers in sleep and circadian research. The program aims to provide trainees with the necessary skills for a productive and successful career, including learning about various funding opportunities, refining research ideas and understanding grant review processes. Trainees will work alongside and learn from other industry professionals to develop a deeper understanding of their role in shaping the future of sleep mechanisms.

    "Avadel is delighted to join the AASM Foundation in its mission to provide educational resources and training to further develop the research careers of sleep scientists, including these 24 deserving trainees," said Jennifer Gudeman, PharmD, Vice President of Medical and Clinical Affairs at Avadel. "Research in sleep health is critical to improving the overall wellbeing of people living with sleep disorders, including narcolepsy. Avadel is proud to support and invest in the next generation of sleep specialists, empowering them to advance this important field of medicine."

    AASM Foundation President Anita V. Shelgikar, MD, MHPE added, "We welcome Avadel's support on the 2021 Young Investigators Research Forum and we appreciate their commitment to investing in the future of sleep research and sleep medicine. Avadel's contributions directly support the AASM Foundation's efforts to establish new awards and initiatives that promote discoveries to advance the understanding of sleep for healthier lives."

    To learn more about the 2021 Young Investigators Research Forum, please visit: https://bit.ly/3qEK1c1

    About Avadel Pharmaceuticals plc:

    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is a biopharmaceutical company primarily focused on the development and FDA approval of FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy. For more information, please visit www.avadel.com.

    About the American Academy of Sleep Medicine Foundation:

    Founded in 1998, the AASM Foundation is a not-for-profit 501(c)(3) charitable and scientific organization that was established by the American Academy of Sleep Medicine. The AASM Foundation has invested in the future of sleep medicine by supporting more than 240 awards totaling $19 million in funding. The AASM Foundation's portfolio includes research awards for all career stages, community awards and training awards. For more information, please visit foundation.aasm.org.

    Contacts:

    Avadel Media Contact

    Patrick Bursey

    LifeSci Communications, LLC

    Phone: (646) 970-4688

    Email:

    AASM Foundation Media Relations

    Phone: (630) 737-9700

    Email:



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  4. DUBLIN, Ireland, March 02, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy, today announced the online publication in Clinical Therapeutics of four Phase 1 studies from the FT218 pharmacokinetic program. Clinical Therapeutics is a leading, peer-reviewed journal publishing recent developments in drug therapy for an international audience of scientists and clinicians.

    Sodium oxybate is recognized as standard of care by the American Academy of Sleep Medicine for patients living with narcolepsy, a chronic neurological condition that impacts…

    DUBLIN, Ireland, March 02, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy, today announced the online publication in Clinical Therapeutics of four Phase 1 studies from the FT218 pharmacokinetic program. Clinical Therapeutics is a leading, peer-reviewed journal publishing recent developments in drug therapy for an international audience of scientists and clinicians.

    Sodium oxybate is recognized as standard of care by the American Academy of Sleep Medicine for patients living with narcolepsy, a chronic neurological condition that impacts about 1 in 2,000 Americans.1 Due to its short half-life, conventional sodium oxybate treatment has required patients to wake up in the middle of the night, two and a half to four hours after their first dose, to take their second dose to maintain therapeutic concentrations. Once-nightly FT218 utilizes Avadel's proprietary, controlled-release technology platform to optimize the pharmacokinetic profile of sodium oxybate by providing a blend of immediate-release and controlled-release microparticles.

    Key findings from the paper, titled "Pharmacokinetics of FT218, a Once-Nightly Sodium Oxybate Formulation in Healthy Adults," include bioequivalent systemic drug exposure, as measured by area-under-the-curve (AUC), for the FT218 6-gram dose compared to immediate-release sodium oxybate given as two, separate 3-gram doses.2 Furthermore, FT218 demonstrated a dose-proportional increase in Cmax and a slightly more than dose-proportional increase in AUC. In all Phase 1 studies, FT218 exhibited a pharmacokinetic profile that supported once-nightly dosing with adequate concentrations maintained throughout the night, and gradual decline to lowest levels by 8-10 hours after dosing (i.e., the time when most patients wake up in the morning).

    "These data should instill confidence in clinicians and patients regarding the robust Phase 1 development program for FT218, with the demonstration of predictable blood levels of the active ingredient with a single dose, and a low residual amount of active drug remaining when a patient would awaken," said David Seiden, M.D., lead author and senior medical director of clinical development and medical affairs at Avadel Pharmaceuticals. "As a sleep medicine physician and researcher, I am pleased that we have leveraged our proven technology to move toward the goal of patients potentially having access to a once-nightly sodium oxybate treatment."

    Results from these four Phase 1 studies have been previously presented at the 15th World Sleep Congress in Vancouver, Canada.3

    For all studies, adverse events with FT218 were mostly mild or moderate in severity, nonserious and known to be associated with sodium oxybate. Most common adverse events included somnolence, dizziness and nausea.

    About FT218

    FT218 is an investigational, once-nightly formulation of sodium oxybate that includes Avadel's MicroPump™ controlled-release (CR) technology. In December 2020, the Company submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for FT218 to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy. On February 26, 2021, the NDA for FT218 was formally accepted for filing by the FDA and issued a target action date of October 15, 2021. FT218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy. The designation was granted on the plausible hypothesis that FT218 may be clinically superior to the twice-nightly formulation of sodium oxybate already approved by the FDA for the same indication. In particular, FT218 may be safer due to ramifications associated with the dosing regimen of the previously approved product.

    About Avadel Pharmaceuticals plc:

    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is a biopharmaceutical company primarily focused on the development and FDA approval of FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy. For more information, please visit www.avadel.com.

    Cautionary Disclosure Regarding Forward-Looking Statements

    This press release includes "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements relate to our future expectations, beliefs, plans, strategies, objectives, results, conditions, financial performance, prospects, or other events. Such forward-looking statements include, but are not limited to, the pharmacokinetic profile of FT218, the bioequivalence of FT218 to twice-nightly sodium oxybate, and the potential benefits of FT218, if approved. In some cases, forward-looking statements can be identified by the use of words such as "will," "may," "could," "believe," "expect," "look forward," "on track," "guidance," "anticipate," "estimate," "project," "next steps" and similar expressions, and the negatives thereof (if applicable).

    Our forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, our business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results and the results of our business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in our forward-looking statements include the risk that the FDA does not approve the NDA for FT218 or such approval is delayed, the risk that FT218 (if approved) may not receive a 7-year Orphan Drug Exclusivity, the risk that commercial launch of FT218 (if approved) is delayed, the risk that the potential market performance for FT218 (if approved) may differ materially from projections, and the risk that the impact of the current COVID-19 pandemic on our financial results and results of operations could be greater than we anticipate and the risks and uncertainties described in the "Risk Factors" section of Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2019, which we filed with the Securities and Exchange Commission (SEC) on March 16, 2020 and subsequent SEC filings.

    Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. We do not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law.

    References:

    1. Morgenthaler, T. I., Kapur, V. K., Brown, T., Swick, T. J., Alessi, C., Aurora, R. N., Boehlecke, B., Chesson, A. L., Jr, Friedman, L., Maganti, R., Owens, J., Pancer, J., Zak, R., & Standards of Practice Committee of the American Academy of Sleep Medicine (2007). Practice parameters for the treatment of narcolepsy and other hypersomnias of central origin. Sleep, 30(12), 1705–1711. https://doi.org/10.1093/sleep/30.12.1705.
    2. Seiden D, Tyler C, Dubrow J. Pharmacokinetics of FT218, a Once-Nightly Sodium Oxybate Formulation in Healthy Adults. Clinical Therapeutics. Online publication ahead of print: https://pubmed.ncbi.nlm.nih.gov/33632533/
    3. Thorpy M., Dubow J., Monteith D., Grassot J., Roth T., Winkelman J., Corser B. The pharmacokinetics of once-nightly controlled- release sodium oxybate (FT218): overview of results from four phase 1 studies. Sleep Medicine. 2019;64(Suppl 1):S385.

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