AVDL Avadel Pharmaceuticals plc

7.81
-0.19  -2%
Previous Close 8
Open 8
52 Week Low 4.83
52 Week High 10.325
Market Cap $456,787,773
Shares 58,487,551
Float 57,063,323
Enterprise Value $393,140,271
Volume 165,235
Av. Daily Volume 263,277
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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
BLOXIVERZ (neostigmine methylsulfate)
Reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery
Approved
Approved
Approved Jun 3 2013
BLOXIVERZ (neostigmine methylsulfate)
Reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery
Approved
Approved
Approved June 3, 2013.
NOURESS (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.
Akovaz
Hypotension
Approved
Approved
Announced approval May 2 2016

Latest News

  1. DUBLIN, Ireland, Aug. 02, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company primarily focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness (EDS) and cataplexy in adults with narcolepsy, announced today that it will host a conference call and live webcast at 8:30 a.m. ET on Monday, August 9, 2021, to provide a corporate update and discuss the Company's financial results for the second quarter ended June 30, 2021.

    To access the conference call, investors are invited to dial (844) 388-0559 (U.S. and Canada) or (216) 562-0393 (International). The conference ID number is 4560878. A live audio webcast can be accessed by visiting the…

    DUBLIN, Ireland, Aug. 02, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company primarily focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness (EDS) and cataplexy in adults with narcolepsy, announced today that it will host a conference call and live webcast at 8:30 a.m. ET on Monday, August 9, 2021, to provide a corporate update and discuss the Company's financial results for the second quarter ended June 30, 2021.

    To access the conference call, investors are invited to dial (844) 388-0559 (U.S. and Canada) or (216) 562-0393 (International). The conference ID number is 4560878. 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 Avadel Pharmaceuticals plc

    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is a biopharmaceutical company primarily focused on the development and U.S. Food and Drug Administration (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.

    Investor Contact:

    Courtney Turiano

    Stern Investor Relations, Inc.



    (212) 698-8687

    Media Contact:

    Nicole Raisch Goelz

    Real Chemistry



    (408) 568-4292



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  2. DUBLIN, Ireland, July 07, 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 Greg Divis, Chief Executive Officer of Avadel, will participate in a fireside chat on Wednesday, July 14 at 11:00 a.m. ET.

    A live webcast of this event, as well as an archived recording, will be available on Avadel's Investor Relations website, www.investors.avadel.com, for 90 days following the conference.

    About Avadel Pharmaceuticals plc
    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is a biopharmaceutical company primarily focused on the development…

    DUBLIN, Ireland, July 07, 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 Greg Divis, Chief Executive Officer of Avadel, will participate in a fireside chat on Wednesday, July 14 at 11:00 a.m. ET.

    A live webcast of this event, as well as an archived recording, will be available on Avadel's Investor Relations website, www.investors.avadel.com, for 90 days following the conference.

    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.

    Investor Contact:

    Courtney Turiano

    Stern Investor Relations, Inc.



    (212) 698-8687

    Media Contact:

    Nicole Raisch Goelz

    Real Chemistry



    (408) 568-4292

     



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    • Data show improvement in excessive daytime sleepiness for both narcolepsy subtypes and with and without stimulant use; demonstrate decreases in weight and body mass index
    • Post hoc analyses further support positive primary and secondary endpoint data for all evaluated doses of FT218
    • Company hosting virtual medical booth to provide detailed information about ongoing research and publications

    DUBLIN, Ireland, June 09, 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 new post hoc analyses of data from the completed pivotal Phase 3…

    • Data show improvement in excessive daytime sleepiness for both narcolepsy subtypes and with and without stimulant use; demonstrate decreases in weight and body mass index

    • Post hoc analyses further support positive primary and secondary endpoint data for all evaluated doses of FT218
    • Company hosting virtual medical booth to provide detailed information about ongoing research and publications

    DUBLIN, Ireland, June 09, 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 new post hoc analyses of data from the completed pivotal Phase 3 REST-ON clinical trial of FT218. The data were presented in three separate posters at SLEEP 2021, the 35th Annual Meeting of the Associated Professional Sleep Societies (APSS), a joint meeting of the American Academy of Sleep Medicine and the Sleep Research Society.

    FT218 is currently under review at the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target date of October 15, 2021.

    "For the past 20 years, the standard of care for narcolepsy has been a twice-nightly medication, a challenging dosing regimen that disrupts nighttime sleep. The new data from the REST-ON trial demonstrate that the once-nightly formulation of sodium oxybate taken at bedtime was effective in addressing the symptoms of narcolepsy without requiring the patient to wake up in the middle of the night," said Asim Roy, M.D., trial investigator and medical director of the Ohio Sleep Medicine Institute. "The new data analyses showing that FT218 improved excessive daytime sleepiness in patients with narcolepsy, both with and without cataplexy, regardless of stimulant use, are important for this patient population. Moreover, the data demonstrating a reduction in weight is an added benefit for narcolepsy patients, who tend to be overweight. I am encouraged by these and other data and believe FT218, if FDA approved, will be an important once-nightly treatment option for people who struggle with managing narcolepsy."

    Highlights from the poster presentations are outlined below.

    Efficacy of FT218, a Once-Nightly Sodium Oxybate Formulation, by Narcolepsy Subtype: A Post Hoc Analysis from the REST-ON Study

    • FT218 demonstrated statistically significant improvement in excessive daytime sleepiness (EDS) at all evaluated doses in patients with narcolepsy subtypes 1 (NT1, with cataplexy) and 2 (NT2, without cataplexy), with greater improvement in measures of EDS, including mean sleep latency on maintenance of wakefulness test (MWT) and Clinical Global Impression-Improvement (CGI-I) in overall condition, compared to placebo.
    • The least squares (LS) mean difference in mean sleep latency (in minutes) on MWT between FT218 and placebo was 6.0 for 9 g (week 13), 7.0 for 7.5 g (week 8), and 4.9 for 6 g (week 3) in NT1 patients (all p<0.001), and 6.3 for 9 g (P<0.05), 4.0 for 7.5 g (P=NS), and 5.3 for 6 g (P<0.05) in NT2 patients.
    • A significantly greater percentage of patients with NT1 receiving FT218 were rated as much or very much improved on the CGI-I compared to placebo: 75.5% vs. 35.9% at 9 g, 66.9% vs. 27.9% at 7.5 g, and 39.9% vs. 7.8% at 6 g (all P<0.001). A greater percentage of NT2 patients receiving FT218 were rated as much/very much improved at all three doses vs. placebo.

    Efficacy of FT218, a Once-Nightly Sodium Oxybate Formulation, by Stimulant Use: A Post Hoc Analysis from the REST-ON Study

    • FT218 demonstrated statistically significant improvement in EDS at all evaluated doses in narcolepsy patients with or without stimulant use, with improvement over placebo on MWT and CGI-I.
    • The LS mean difference in mean sleep latency (in minutes) on MWT between FT218 and placebo was 6.0 for 9 g (week 13), 5.5 for 7.5 g (week 8), and 5.4 for 6 g (week 3) for patients with concomitant stimulant use (all P≤0.001). For patients not taking stimulants, the LS mean difference was 6.3 for 9 g (P=0.001), 7.1 for 7.5 g (P<0.001), and 4.2 for 6 g (P<0.01).
    • More patients receiving FT218 were rated much/very much improved on CGI-I compared to placebo: 80.5% vs. 35.3% at 9 g, 66.3% vs. 26.5% at 7.5 g, and 39.8% vs. 4.4% at 6 g for patients with stimulant use (all P<0.001); 55.1% vs. 27.2% at 9 g (P<0.05), 54.5% vs. 17.5% at 7.5 g (P=0.006), and 40.0% vs. 7.7% at 6 g (P<0.01) for patients without stimulant use.

    Weight Loss with FT218, a Once-Nightly Sodium Oxybate Formulation for the Treatment of Narcolepsy: Post Hoc Analysis from REST-ON

    • Patients receiving FT218 experienced a significantly greater decrease in weight and body mass index (BMI) from baseline to study end (week 13) compared to placebo.
    • At study end, the mean (SD) change in weight from baseline was –1.3 (3.6) kg for patients receiving FT218 compared to 0.2 (2.6) kg for patients receiving placebo. Overall, 17.8% of patients receiving FT218 compared to 3.8% of patients receiving placebo experienced ≥5% weight loss.
    • At study end, the LS mean (SE) change in BMI from baseline was ‒0.5 (0.13) kg/m2 for patients receiving FT218 and 0.1 (0.13) kg/m2 for patients receiving placebo (P=0.001).

    "Avadel is focused on providing a meaningful solution for people with narcolepsy and we are pleased to share further evidence of the clinical benefit of FT218, taken once at bedtime," said Jennifer Gudeman, PharmD, Vice President of Medical and Clinical Affairs at Avadel. "We leveraged our unique scientific capabilities to develop a proprietary formulation of sodium oxybate to address the limitations of currently available treatments that require twice-nightly dosing. We believe these new analyses, along with previously presented REST-ON positive Phase 3 data, strengthen the body of evidence demonstrating that FT218, if approved, has the potential to be a transformative treatment for people living with narcolepsy."

    Previously released results from the REST-ON trial demonstrated highly statistically significant (p<0.001 compared to placebo) and clinically meaningful improvement across all three co-primary endpoints (MWT, CGI-I and mean weekly cataplexy attacks) with FT218 at 6, 7.5 and 9 g. Secondary endpoint data for FT218 taken once at bedtime demonstrated clinically meaningful results at all tested doses, for reducing disturbed nocturnal sleep; additional post hoc analyses further demonstrated significant increase in time in deep sleep, and significant decrease in light sleep compared to placebo for doses evaluated beginning by week 3 with only a 6-g-dose. As reported at the American Academy of Neurology 2021 meeting, FT218 also demonstrated a significant improvement in the Epworth Sleepiness Scale, a patient reported outcome, and significantly improved patient perceptions of the quality and refreshing nature of sleep at all doses tested beginning by week 3. FT218 taken once at bedtime at 9 g was generally well tolerated with commonly known sodium oxybate adverse reactions occurring at low rates. These findings will also be presented by Avadel at SLEEP 2021 in an oral and poster session (abstract # 488) and two additional posters (abstract # 489 and 490).

    The Company is also hosting a virtual medical booth that houses the posters, an on-demand symposium titled "How Narcolepsy Management Is Evolving: Expert Panel Discussion," and detailed information about its ongoing research and publications. The virtual medical booth can be accessed at http://www.sleep2021.avadelmedicalbooth.com/ until November 30, 2021.

    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 U.S. Food and Drug Administration (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 the Company's future expectations, beliefs, plans, strategies, objectives, results, conditions, financial performance, prospects, or other events. Such forward-looking statements include, but are not limited to, expectations regarding the tolerability or therapeutic benefits of FT218, the timing of 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).

    The Company's 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, the Company's business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results and the results of the Company's 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 the Company's forward-looking statements include: the risk that positive results from the REST-ON trial may not necessarily be predictive of the results of future or ongoing clinical studies; 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 commercial launch of FT218 (if approved) is delayed or never occurs; 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 the Company's 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 the Company's Annual Report on Form 10-K for the year ended December 31, 2020, which was filed with the Securities and Exchange Commission (SEC) on March 9, 2021 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. The Company does not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law.

    Contacts:

    Investor Contact:

    Courtney Turiano

    Stern Investor Relations, Inc.



    (212) 698-8687

    Media Contact:

    Nicole Raisch Goelz

    Real Chemistry



    (408) 568-4292



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  3. DUBLIN, Ireland, June 03, 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 it will present primary and secondary endpoint data, including new post hoc analyses, from the pivotal Phase 3 REST-ON clinical trial at SLEEP 2021, at the 35th Annual Meeting of the Associated Professional Sleep Societies (APSS). This joint meeting of the American Academy of Sleep Medicine and the Sleep Research Society is being held virtually from June 10-13, 2021.

    Avadel will present FT218 efficacy and safety data from six abstracts, which have been…

    DUBLIN, Ireland, June 03, 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 it will present primary and secondary endpoint data, including new post hoc analyses, from the pivotal Phase 3 REST-ON clinical trial at SLEEP 2021, at the 35th Annual Meeting of the Associated Professional Sleep Societies (APSS). This joint meeting of the American Academy of Sleep Medicine and the Sleep Research Society is being held virtually from June 10-13, 2021.

    Avadel will present FT218 efficacy and safety data from six abstracts, which have been published in an online supplement in the journal Sleep. Details of the presentations are as follows:

    Oral Presentation

    Abstract #: 488

    Title: REST-ON: Efficacy of FT218 for Daytime Sleepiness, Sleep Quality, Hallucinations and Sleep Paralysis in Patients with Narcolepsy

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

    Session: O-14: Innovation in the Assessment and Management of Central Hypersomnia

    Date and Time: Sunday, June 13, 2021 at 1:03-1:14 p.m. EDT

    The oral presentation will also be available as a poster.

    Poster Presentations

    Abstract #: 491

    Title: Efficacy of FT218, a Once-Nightly Sodium Oxybate Formulation, by Narcolepsy Subtype: A Post Hoc Analysis from the REST-ON Study

    Presenter: Asim Roy, M.D., Ohio Sleep Medicine Institute



    Abstract #: 492

    Title: Efficacy of FT218, a Once-Nightly Sodium Oxybate Formulation, by Stimulant Use: A Post Hoc Analysis from the REST-ON Study

    Presenter: Asim Roy, M.D., Ohio Sleep Medicine Institute

    Abstract #: 493

    Title: Weight Loss with FT218, a Once-Nightly Sodium Oxybate Formulation for the Treatment of Narcolepsy: Post Hoc Analysis from REST-ON

    Presenter: Anne Marie Morse, D.O., Geisinger Medical Center, Janet Weis Children's Hospital



    Abstract #: 489

    Title: Pivotal Phase 3 Study of FT218, a Once-Nightly Sodium Oxybate Formulation, in Patients with Narcolepsy: REST-ON Primary Results

    Presenter: Clete Kushida M.D., Ph.D., Stanford Sleep Medicine Center

    Abstract #: 490

    Title: Efficacy of FT218 on Polysomnographic Measures of Sleep Continuity in Patients with Narcolepsy: Results from the REST-ON Trial

    Presenter: Yves Dauvilliers, M.D., Ph.D., Sleep and Wake Disorders Centre, Department of Neurology, Gui de Chauliac Hospital

    For registered meeting attendees, posters will be available from June 11 to November 30, 2021, in the e-Poster gallery on the SLEEP 2021 website at https://www.sleepmeeting.org/. Posters also will be housed in Avadel's virtual medical booth, with the three posters covering pre-specified primary and secondary endpoints featured in an interactive format with commentary from Dr. Roy, medical director of the Ohio Sleep Medicine Institute. The booth will also include more detailed information about the Company and its ongoing research and publications.

    In addition to Avadel's virtual medical booth, the Company will support a symposium titled "How Narcolepsy Management Is Evolving: Expert Panel Discussion." The symposium will be moderated by Dr. Thorpy, director of the Sleep-Wake Disorders Center at Montefiore and professor of neurology at Albert Einstein College of Medicine, and will be available on-demand on the SLEEP 2021 website and in the Company's virtual medical booth until November 30, 2021.

    About FT218

    FT218 is an investigational, once-nightly formulation of sodium oxybate that includes Avadel's MicroPump™ controlled-release 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 NDA to the 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 PDUFA target action date of October 15, 2021. FT218 has been granted Orphan Drug Designation from the 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 U.S. Food and Drug Administration (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.

    Contacts:

    Investor Contact:

    Courtney Turiano

    Stern Investor Relations, Inc.



    (212) 698-8687

    Media Contact:

    Nicole Raisch Goelz

    Real Chemistry



    (408) 568-4292



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  4. DUBLIN, Ireland, June 02, 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 it has appointed Jeff Cruikshank as Vice President, Sales; Denise Strauss as Vice President, Marketing and New Product Strategy; and Angela Woods as Vice President, People and Culture.

    These newly-created roles will continue to build the Company's capabilities to support the potential approval and commercialization of once-nightly FT218. As Vice President, Sales, Mr. Cruikshank will lead the development of Avadel's go-to-market customer model including…

    DUBLIN, Ireland, June 02, 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 it has appointed Jeff Cruikshank as Vice President, Sales; Denise Strauss as Vice President, Marketing and New Product Strategy; and Angela Woods as Vice President, People and Culture.

    These newly-created roles will continue to build the Company's capabilities to support the potential approval and commercialization of once-nightly FT218. As Vice President, Sales, Mr. Cruikshank will lead the development of Avadel's go-to-market customer model including the buildout and deployment of the Company's patient-focused sales team. Ms. Strauss, Vice President, Marketing and New Product Strategy, will be responsible for the market preparation and launch of FT218, future new product strategy, and building out the marketing team. Ms. Woods as Vice President, People and Culture, will lead the Company's human resources function, and will be responsible for implementing strategies that support the growth of the organization and cultivating a culture reflective of its vision and core values.

    "We believe once-nightly FT218 has the potential to truly impact the way people with narcolepsy are able to live their lives. As we accelerate our launch preparations and commercialization strategy ahead of the anticipated U.S. regulatory approval, we are thrilled to welcome these three talented biopharma leaders to our growing team," said Greg Divis, Chief Executive Officer of Avadel. "Jeff, Denise and Angela each bring diverse experience to Avadel. Their collective expertise launching innovative therapies in competitive markets and scaling organizations will be invaluable as we progress toward our shared vision of making FT218 available to patients seeking a new treatment option for managing the relentless daytime and nighttime symptoms of narcolepsy."

    New Avadel Leadership Team Members

    • Jeff Cruikshank, Vice President, Sales, is an accomplished leader with more than two decades of experience in sales and marketing, product launches and brand building across various therapeutic areas in both emerging and competitive markets. Prior to joining Avadel, Mr. Cruikshank held positions of increasing leadership in sales and commercial training at Ironwood Pharmaceuticals, Novartis, and Janssen Pharmaceuticals. He earned a bachelor's degree in business administration in management from East Tennessee State University in Johnson City.



    • Denise Strauss, Vice President, Marketing and New Product Strategy, is an industry-leading biopharmaceutical marketer who has successfully launched more than a dozen products and devices in a variety of therapeutic areas, for companies including Genfit, Pfizer, Schering-Plough and Boehringer Ingelheim. During her career, she has been responsible for leading marketing strategy and execution across billion-dollar brands and multi-billion-dollar portfolios. She earned a B.S. in communication from Cornell University and an MBA in marketing from Pace University.



    • Angela Woods, Vice President, People and Culture, is a highly regarded human resources executive with a track record for growing successful, high-performing teams spanning multiple industries, global organizations and diverse workforces. Prior to joining Avadel, she served as Vice President, Human Resources, at Mallinckrodt Pharmaceuticals, where she oversaw the development of talent strategies in support of the company's new product launches, multiple M&A integrations, culture building and business transformation. She earned a B.S. in finance from Southern Illinois University at Carbondale.

    About FT218

    FT218 is an investigational, once-nightly formulation of sodium oxybate that includes Avadel's MicroPump™ controlled-release 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 NDA to the 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 PDUFA target action date of October 15, 2021. FT218 has been granted Orphan Drug Designation from the 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 presentation of additional clinical trial data for FT218, the commercial launch, including timing and success of FT218 (if approved), the market acceptance of FT218 (if approved), and the anticipated contribution of the new hires of the Company to its success and progress. 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).

    The Company's 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, the Company's business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results and the results of the company's 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 the Company's 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 commercial launch of FT218 (if approved) is delayed or never occurs; the risk that the potential market acceptance of FT218 (if approved) may differ materially from projections; and the risk that the impact of the current COVID-19 pandemic on the Company's 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 the Company's Annual Report on Form 10-K for the year ended December 31, 2020, which was filed with the Securities and Exchange Commission (SEC) on March 9, 2021 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. The Company does not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law.

    Investor Contact:

    Courtney Turiano

    Stern Investor Relations, Inc.



    (212) 698-8687

    Media Contact:

    Nicole Raisch Goelz

    Real Chemistry



    (408) 568-4292



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