IMPL Impel NeuroPharma Inc.
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
INP107 (Levodopa/Carbidopa)
Morning OFF Episodes in Parkinson’s
|
Phase 1
Phase 1
|
Phase 1 trial completed. PK study for pivotal dose selection to be initiated in 2022.
|
|
INP105 (Olanzapine) - CALM 201
Acute Agitation
|
Phase 2
Phase 2
|
Phase 2 trial to be initiated late 4Q 2021.
|
|
TRUDHESA (Dihydroergotamine)
Migraine
|
Approved
Approved
|
Approved September 3, 2021.
|
Latest News
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Launched Trudhesa™ (dihydroergotamine mesylate) Nasal Spray (0.725 mg per spray) for the Acute Treatment of Migraine with and without Aura in Adults
Mobilized 60-Person Salesforce with a Targeted Focus on High-Prescribing Neurologists, Headache Specialists and Primary Care Physicians
Increased Cash Position and Extended Runway into 2023 with Follow-on Equity Offering of 3.45 Million Shares Valued at $51.8 Million
Company Plans to Initiate Phase 2a Proof-of-Concept Trial Evaluating INP105 in Agitation and Aggression in Autism in Late Q4 2021
Impel to Host Investor Conference Call Today at 8:30 a.m. ET
SEATTLE, Nov. 15, 2021 (GLOBE NEWSWIRE) -- Impel NeuroPharma (NASDAQ:IMPL), a commercial-stage pharmaceutical company developing transformative therapies for people suffering from diseases with high unmet medical needs, with an initial focus on the central nervous system, today reported financial results for the third quarter ended September 30, 2021 and provided a corporate update.
"With the approval and timely launch of Trudhesa, the third quarter was truly transformational for Impel. We are delighted by the early uptake and prescription trends we are seeing in the marketplace since our commercial launch in early October," said Adrian Adams, chairman and chief executive officer of Impel NeuroPharma. "Following the recent follow-on equity offering, we are confident that Impel's strengthened balance sheet will provide us not only with the resources to continue our successful commercialization of Trudhesa, but also the continued development of INP105 for the potential treatment of agitation and aggression in autism."
Recent Corporate Highlights
- On September 3, the company announced that the U.S. Food and Drug Administration (FDA) approved Trudhesa (dihydroergotamine mesylate) nasal spray (0.725 mg per spray) for the acute treatment of migraine with or without aura in adults. Trudhesa was previously known as INP104. The IR call webcast recording can be accessed here.
- On September 9, the company closed a public offering of 3,450,000 shares of its common stock at a price to the public of $15.00 per share. All of the shares of common stock were offered by Impel. The gross proceeds from the offering, before deducting underwriting discounts and commissions, and other offering expenses payable by Impel, were $51.8 million. Cowen and Guggenheim Securities acted as joint bookrunning managers for the proposed offering. Wedbush PacGrow was a lead manager.
- Key endpoint results from the pivotal Phase 3 STOP 301 study of Trudhesa were presented at the 2021 PainWEEK Conference and the International Headache Congress IHS and EHF Joint Congress 2021, underscoring the need for a non-oral treatment option for acute migraine. The presentations also looked at the exploratory efficacy data from STOP 301 suggesting improvements in migraine-related disability as assessed by the MIDAS questionnaire.
- On September 23, the company announced Trudhesa's availability through Trudhesa Direct™, a streamlined, customized, end-to-end process that provides hassle-free prescribing, savings, and home delivery. The digital pharmacy partners, Carepoint Pharmacy and Phil Inc., facilitate the process beginning with e-prescribing and automatic enrollment of eligible, commercially insured patients in the Trudhesa Direct™ Savings Program to obtain Trudhesa.
- The clinical development program evaluating INP105 in agitation and aggression in autism is progressing on track; the company plans to initiate a Phase 2a proof-of-concept trial, known as the CALM 201 Study, in late Q4 2021.
Third Quarter 2021 Financial Results
- Product Revenue, Net: We recorded net product revenues in the third quarter of 2021 following the approval of Trudhesa on September 2, 2021. Although the product was not commercially launched in the U.S. until October 4, 2021, we recognized $0.1 million of product revenue, net of sales allowances and rebates, related to sales of Trudhesa during the three months ending September 31, 2021.
- Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2021 were $5.9 million, which compares with $6.1 million for the third quarter of 2020. The decrease in R&D spending was due primarily to the decrease in Trudhesa clinical expenses as the Phase 3 study was closed.
- Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the third quarter of 2021 were $16.3 million, which compares with $2.9 million for the third quarter of 2020. The increase in SG&A was primarily due to the ramp up in spending to support the commercial and marketing preparation for the Trudhesa launch.
- GAAP Net Loss: For the third quarter of 2021, Impel reported a net loss of $25.0 million, compared to a net loss of $9.2 million for same period in 2020.
- GAAP Net Loss Per Share: GAAP Net Loss Per Share totaled $1.24 per share in the third quarter of 2021 and $15.56 in the third quarter of 2020. The weighted average share count used in our GAAP net loss per share calculation in the third quarter of 2020 does not reflect the issuance of 5.3 million shares of common stock in our IPO, 0.07 million shares upon conversion of our convertible preferred stock warrants, and 12.6 million shares upon the April 2021 conversion of our preferred stock.
- Non-GAAP Net Loss Per Share: Non-GAAP Net Loss Per Share was $1.23 for the third quarter of 2021, and $0.49 for the third quarter of 2020. Non-GAAP Pro Forma Net Loss Per Share gives effect to our reverse stock split, the shares of common stock issued in our IPO, and the conversion of our convertible preferred stock and our convertible notes into shares of common stock as if such conversions occurred at the beginning of each period presented. Non-GAAP Net Loss Per Share excludes the effect of accretion on our redeemable convertible preferred stock and interest expense on our convertible notes, all of which converted to shares of common stock in our April 2021 IPO. Please refer to the section in this press release titled "Reconciliation of GAAP and Non-GAAP Results" for details.
- Cash Balance: As of September 30, 2021, the company had cash and cash equivalents of $111.3 million.
Conference Call Information
Impel NeuroPharma's Executive Management will host a live conference call and webcast at 8:30 a.m. ET today to discuss the third quarter 2021 financial results and provide a corporate update. The conference call may be accessed by dialing 877-295-2648 (domestic) or 470-495-9487 (international) and referring to conference ID 8366131. A live webcast of the event will be available on the Investors section of the Impel NeuroPharma website at https://investors.impelnp.com/. A replay of the webcast and accompanying slides will be available on the Impel NeuroPharma website following the event.Non-GAAP Financial Measures
We have provided in this press release certain financial information that has not been prepared in accordance with generally accepted accounting principles in the United States ("GAAP"). Our management uses these non-GAAP financial measures internally in analyzing our financial results and believes that use of these non-GAAP financial measures is useful to investors as an additional tool to evaluate ongoing operating results and trends and in comparing our financial results with other companies in our industry, many of which present similar non-GAAP financial measures. Non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable financial measures prepared in accordance with GAAP and should be read only in conjunction with our consolidated financial statements prepared in accordance with GAAP. A reconciliation of our historical non-GAAP financial measures to the most directly comparable GAAP measures has been provided in the financial statement tables included in this press release, and investors are encouraged to review these reconciliations.About Impel NeuroPharma
Impel NeuroPharma, Inc. is a commercial-stage biopharmaceutical company developing transformative therapies for people suffering from diseases with high unmet medical needs, with an initial focus on diseases of the central nervous system. Impel offers and is developing treatments that pair its proprietary Precision Olfactory Delivery (POD®) technology with well-established therapeutics. In addition to Trudhesa™ (dihydroergotamine mesylate) nasal spray, which is approved in the United States for the acute treatment of migraine with or without aura in adults, Impel is also developing INP105 for the acute treatment of agitation and aggression in patients with autism, and INP107 for OFF episodes in Parkinson's disease.Trudhesa™ Indication and Important Safety Information
Indication
Trudhesa™ is used to treat an active migraine headache with or without aura in adults. Do not use Trudhesa to prevent migraine when you have no symptoms. It is not known if Trudhesa is safe and effective in children.Important Safety Information
Serious or potentially life-threatening reductions in blood flow to the brain or extremities due to interactions between dihydroergotamine (the active ingredient in Trudhesa) and strong CYP3A4 inhibitors (such as protease inhibitors and macrolide antibiotics) have been reported rarely. As a result, these medications should not be taken together. Do not use Trudhesa if you:
- Have any disease affecting your heart, arteries, or blood circulation.
- Are taking certain anti-HIV medications known as protease inhibitors (such as ritonavir or nelfinavir).
- Are taking a macrolide antibiotic such as clarithromycin or erythromycin.
- Are taking certain antifungals such as ketoconazole or itraconazole.
- Have taken certain medications such as triptans or ergot-type medications for the treatment or prevention of migraine within the last 24 hours.
- Have taken any medications that constrict your blood vessels or raise your blood pressure.
- Have severe liver or kidney disease.
- Are allergic to ergotamine or dihydroergotamine.
Before taking Trudhesa, tell your doctor if:
- You have high blood pressure, chest pain, shortness of breath, heart disease; or risk factors for heart disease (such as high blood pressure, high cholesterol, obesity, diabetes, smoking, strong family history of heart disease or you are postmenopausal, or male over 40); or problems with blood circulation in your arms, legs, fingers, or toes.
- You have or had any disease of the liver or kidney.
- You are taking any prescription or over-the-counter medications, including vitamins or herbal supplements.
- You are pregnant, planning to become pregnant or are nursing, or have ever stopped medication due to an allergy or bad reaction.
- This headache is different from your usual migraine attacks.
The use of Trudhesa should not exceed dosing guidelines and should not be used on a daily basis. Serious cardiac (heart) events, including some that have been fatal, have occurred following the use of dihydroergotamine mesylate, particularly with dihydroergotamine for injection, but are extremely rare.
You may experience some nasal congestion or irritation, altered sense of taste, sore throat, nausea, vomiting, dizziness, and fatigue after using Trudhesa.
Contact your doctor immediately if you experience:- Numbness or tingling in your fingers and toes
- Severe tightness, pain, pressure, heaviness, or discomfort in your chest
- Muscle pain or cramps in your arms or legs
- Cold feeling or color changes in 1 or both legs or feet
- Sudden weakness
- Slurred speech
- Swelling or itching
The risk information provided here is not comprehensive. To learn more, talk about Trudhesa with your healthcare provider or pharmacist. The FDA-approved product labeling can be found at www.trudhesa.com or 1-800-555-DRUG. You can also call 1-833-TRUDHESA (1-833-878-3437) for additional information.
About INP105
INP105 is an upper nasal formulation of olanzapine administered using Impel's novel Precision Olfactory Delivery, or POD®, technology and being developed for the potential treatment of agitation and aggression associated with autism spectrum disorder (ASD). The POD is a novel, simple-to-use device designed to deliver consistent and predictable doses of drug. INP105 delivers olanzapine to the richly vascularized upper nasal space offering rapid, consistent, and optimized bioavailability that can be administered by the patient or a caregiver. Olanzapine is the most used treatment for acute agitation, but its use is limited to intramuscular injection and in a hospital setting. INP105 is intended to be a preferred choice for the safe and rapid treatment of acute agitation and, because it is designed to be non-invasive, it has the potential to expand the treatment setting beyond the emergency room, such as inpatient treatment or community care facilities and the patient's home.Cautionary Note on Forward-Looking Statements
This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, the potential clinical benefits of Trudhesa™, the market opportunities of Trudhesa within the migraine market, the speed of uptake and market growth of Trudhesa, and the timing of announcements of clinical results and clinical development activities of Impel's product candidates. Forward-looking statements can be identified by words such as: "believe," "may," "will," "potentially," "estimate," "continue," "anticipate," "intend," "could," "would," "project," "plan," "expect" or the negative or plural of these words or similar expressions. These statements are subject to numerous risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including but not limited to, Impel's ability to maintain regulatory approval of Trudhesa, its ability to execute its commercialization strategy for Trudhesa, its ability to develop, manufacture and commercialize its other product candidates including plans for future development of its POD devices and plans to address additional indications for which Impel may pursue regulatory approval, whether results of preclinical studies or clinical trials will be indicative of the results of future trials, and the effects of COVID-19 on its clinical programs and business operations. Many of these risks are described in greater detail in Impel's filings with the Securities and Exchange Commission. Any forward-looking statements in this press release speak only as of the date of this press release. Impel assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.Impel, POD and the Impel logo are trademarks of Impel NeuroPharma, Inc. To learn more about Impel NeuroPharma, please visit our website at https://impelnp.com/.
IMPEL NEUROPHARMA, INC.
Condensed Consolidated Balance Sheet
(In thousands, except share and per share data)September 30, 2021 December 31, 2020 Assets Current assets: Cash and cash equivalents $ 111,289 $ 7,095 Trade receivables, net 981 — Inventory 1,548 — Prepaid expenses and other current assets 4,385 1,077 Total current assets 118,203 8,172 Property and equipment, net 3,278 3,700 Other assets — 187 Total assets $ 121,481 $ 12,059 Liabilities, redeemable convertible preferred stock and stockholders' equity (deficit) Current liabilities: Accounts payable $ 8,700 $ 4,314 Accrued liabilities 6,692 3,173 Current portion of term debt — 417 Common stock warrant liabilities 918 — Redeemable convertible preferred stock warrant liabilities — 2,622 Total current liabilities 16,310 10,526 Long-term debt 29,285 7,994 Total liabilities 45,595 18,520 Commitments and contingencies (Note 5) Redeemable convertible preferred stock, $0.001 par value; — and 204,198,489 shares authorized at September 30, 2021 and December 31, 2020 respectively; — and 202,009,981 shares issued and outstanding at September 30, 2021 and December 31, 2020 respectively; aggregate liquidation preference of $128,922 at December 31, 2020 — 127,039 Stockholders' equity (deficit): Preferred stock, $0.001 par value; 10,000,000 and — shares authorized at September 30, 2021 and December 31, 2020, respectively — — Common stock, $0.001 par value; 300,000,000 and 266,833,885 shares authorized at September 30, 2021 and December 31, 2020, respectively; 23,037,298 and 755,478 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively 23 - Additional paid-in capital 265,919 4,762 Accumulated deficit (190,056 ) (138,262 ) Total stockholders' equity (deficit) 75,886 (133,500 ) Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficit) $ 121,481 $ 12,059 Impel NeuroPharma Inc.
Condensed Consolidated Statement of Operations and Comprehensive Loss
(in thousands)For the Three Months Ended
September 30,For the Nine Months Ended
September 30,2021 2020 2021 2020 Product revenue, net $ 91 $ — $ 91 $ — Cost of goods sold 250 — 250 — Gross profit (159 ) — (159 ) — Operating expenses: Research and development 5,929 6,133 16,103 19,524 Selling, general and administrative 16,338 2,866 30,971 12,240 Total operating expenses 22,267 8,999 47,074 31,764 Loss from operations (22,426 ) (8,999 ) (47,233 ) (31,764 ) Other (expense) income, net (2,595 ) (93 ) (4,561 ) (9 ) Loss before income taxes (25,021 ) (9,092 ) (51,794 ) (31,773 ) Provision (benefit) for income taxes — 1 — 1 Net loss and comprehensive loss $ (25,021 ) $ (9,093 ) $ (51,794 ) $ (31,774 ) Accretion on redeemable convertible preferred stock — 130 129 386 Net loss attributable to common stockholders $ (25,021 ) $ (9,223 ) $ (51,923 ) $ (32,160 ) Net loss per share attributable to common stockholders, basic and diluted $ (1.24 ) $ (15.56 ) $ (4.42 ) $ (73.16 ) Weighted-average shares used in computing net loss per share attributable to common
stockholders, basic and diluted20,150,990 592,550 11,746,923 439,575 Impel Neuropharma, Inc.
Earnings Per Share
(in thousands, except share and per share amounts)For the Three Months Ended
September 30,For the Nine Months Ended
September 30,2021 2020 2021 2020 GAAP Basic and Diluted EPS Numerator: Net loss and comprehensive loss $ (25,021 ) $ (9,093 ) $ (51,794 ) $ (31,774 ) Add: Accretion of preferred stock to redemption value - 130 129 386 Net loss attributable to common shareholders $ (25,021 ) $ (9,223 ) $ (51,923 ) $ (32,160 ) Denominator: Weighted-average common shares outstanding, basic and diluted 20,150,990 592,550 11,746,923 439,575 Net loss per share attributable to common shareholders, basic and diluted $ (1.24 ) $ (15.56 ) $ (4.42 ) $ (73.16 ) For the Three Months Ended
September 30,For the Nine Months Ended
September 30,2021 2020 2021 2020 Non-GAAP loss per share information: Numerator: Historical net loss attributable to common shareholders $ (25,021 ) $ (9,223 ) $ (51,923 ) $ (32,160 ) Accretion of preferred stock to redemption value - 130 129 386 Change in fair value of convertible notes - - 839 0 Change in fair value of redeemable convertible preferred stock warrant liabilities - (35 ) 222 (80 ) Interest expense on convertible notes - - 55 - Non-GAAP pro forma net loss attributable to common stockholders $ (25,021 ) $ (9,128 ) $ (50,678 ) $ (31,854 ) Denominator: Common shares outstanding: Weighted average common shares outstanding 20,150,990 592,550 11,746,923 439,575 Shares issued in IPO - 5,333,334 2,266,179 5,333,334 Common shares issued upon conversion of preferred stock - 12,592,799 5,356,311 12,592,799 Automatic exchange of Avenue warrant - - 45,747 - Issuance of shares of common stock pursuant to the cash and net exercise of warrants - 67,897 26,138 68,175 Shares issued upon conversion of convertible notes - - 237,772 - Weighted-average number of common shares outstanding used to compute pro forma net loss per share, as adjusted, basic and diluted 20,150,990 18,586,580 19,679,070 18,433,883 Pro forma net loss per share attributable to common shareholders, basic and diluted $ (1.24 ) $ (0.49 ) $ (2.58 ) $ (1.73 ) Contact:
Investor Relations:
Christina Tartaglia
Stern Investor Relations
Phone: (1) 212-362-1200
Email: [email protected]Media Relations:
Melyssa Weible
Elixir Health Public Relations
Phone: (1) 201-723-5805
Email: [email protected]
- On September 3, the company announced that the U.S. Food and Drug Administration (FDA) approved Trudhesa (dihydroergotamine mesylate) nasal spray (0.725 mg per spray) for the acute treatment of migraine with or without aura in adults. Trudhesa was previously known as INP104. The IR call webcast recording can be accessed here.
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SEATTLE, Nov. 09, 2021 (GLOBE NEWSWIRE) -- Impel NeuroPharma, Inc. (NASDAQ:IMPL), a commercial-stage biopharmaceutical company developing transformative therapies for people suffering from diseases with high unmet medical needs, with an initial focus on the central nervous system (CNS), today announced that Adrian Adams, Chairman and CEO, will participate in a fireside chat at the Guggenheim Securities 3rd Annual Neuro/Immunology Conference on Tuesday, November 16, 2021 at 1:40 p.m. ET.
A live webcast of the event will be available on the Investors section of the Impel NeuroPharma website at https://investors.impelnp.com/. A replay of the presentation will be available on the Impel NeuroPharma website following the event.
About Impel NeuroPharma
Impel NeuroPharma, Inc. is a commercial-stage biopharmaceutical company developing transformative therapies for people suffering from diseases with high unmet medical needs, with an initial focus on diseases of the central nervous system. Impel offers and is developing treatments that pair its proprietary Precision Olfactory Delivery (POD®) technology with well-established therapeutics. In addition to Trudhesa™ (dihydroergotamine mesylate) nasal spray, which is approved in the United States for the acute treatment of migraine with or without aura in adults, Impel is also developing INP105 for the acute treatment of agitation and aggression in patients with autism, and INP107 for OFF episodes in Parkinson's disease.
Investor Relations:
Christina Tartaglia
Stern Investor Relations
Phone: (1) 212-362-1200
Email: [email protected]Media Relations:
Melyssa Weible
Elixir Health Public Relations
Phone: (1) 201-723-5805
Email: [email protected]
-
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SEATTLE, Nov. 08, 2021 (GLOBE NEWSWIRE) -- Impel NeuroPharma, Inc. (NASDAQ:IMPL), a commercial-stage biopharmaceutical company developing transformative therapies for people suffering from diseases with high unmet medical needs, with an initial focus on the central nervous system (CNS), today announced that management will host a live webcast on Monday, November 15, 2021 at 8:30 a.m. ET to report its third quarter 2021 financial results and provide a business update.
The conference call may be accessed by dialling 877-295-2648 (domestic) or 470-495-9487 (international) and referring to conference ID 8366131. A live webcast of the event will be available on the Investors section of the Impel NeuroPharma website at https://investors.impelnp.com/. A replay of the webcast and accompanying slides will be available on the Impel NeuroPharma website following the event.
About Impel NeuroPharma
Impel NeuroPharma, Inc. is a commercial-stage biopharmaceutical company developing transformative therapies for people suffering from diseases with high unmet medical needs, with an initial focus on diseases of the central nervous system. Impel offers and is developing treatments that pair its proprietary Precision Olfactory Delivery (POD®) technology with well-established therapeutics. In addition to Trudhesa™ (dihydroergotamine mesylate) nasal spray, which is approved in the United States for the acute treatment of migraine with or without aura in adults, Impel is also developing INP105 for the acute treatment of agitation and aggression in patients with autism, and INP107 for OFF episodes in Parkinson's disease.
Investor Relations:
Christina Tartaglia
Stern Investor Relations
Phone: (1) 212-362-1200
Email: [email protected]Media Relations:
Melyssa Weible
Elixir Health Public Relations
Phone: (1) 201-723-5805
Email: [email protected]
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SAN FRANCISCO, Sept. 29, 2021 /PRNewswire/ -- Phil, Inc. announces partnership with Impel NeuroPharma, Inc. (NASDAQ: IMPL) in support of Trudhesa™ (dihydroergotamine mesylate) nasal spray (0.725 mg per spray) to provide technology-powered patient support and distribution services through Phil's proprietary workflow to enhance the patient's access to therapy. Trudhesa is indicated for the acute treatment of migraine with or without aura in adults.
"Phil provides an efficient and value-driven experience for patients to get timely and affordable access to their medications," said Deepak Thomas, founder and CEO of Phil. "The challenges in this space reach far beyond the patient, and our goal is to simplify this complex ecosystem to deliver positive outcomes for all stakeholders."
"Every step of our Trudhesa development program has been guided by the needs of people living with migraine," said Adrian Adams, Chairman and Chief Executive Officer, Impel NeuroPharma. "That's why we're excited to partner with Phil on Trudhesa Direct™, a streamlined, customized, end-to-end process that will automatically enroll eligible, commercially-insured patients in a savings program to obtain and conveniently ship the medication straight to their home at no additional cost. This partnership will create a customized and seamless experience for patients who choose Trudhesa for rapid, sustained and consistent migraine relief."
About Trudhesa™ (dihydroergotamine mesylate) Nasal Spray
Trudhesa™ (dihydroergotamine mesylate) nasal spray (0.725 mg per spray) is approved by the U.S. Food and Drug Administration for the acute treatment of migraine with or without aura in adults in the U.S. Using Impel's proprietary Precision Olfactory Delivery (POD®) Technology, Trudhesa gently delivers dihydroergotamine mesylate (DHE)—a proven, well-established therapeutic —quickly to the bloodstream through the vascular-rich upper nasal space. Trudhesa bypasses the gut and potential absorption issues, offering the potential for rapid, sustained, and consistent relief without injection or infusion, even when administered hours after the start of a migraine attack.iTrudhesa Indication and Important Safety Information
Indication
Trudhesa is used to treat an active migraine headache with or without aura in adults. Do not use Trudhesa to prevent migraine when you have no symptoms. It is not known if Trudhesa is safe and effective in children.
Important Safety Information
Serious or potentially life-threatening reductions in blood flow to the brain or extremities due to interactions between dihydroergotamine (the active ingredient in Trudhesa) and strong CYP3A4 inhibitors (such as protease inhibitors and macrolide antibiotics) have been reported rarely. As a result, these medications should not be taken together.
Do not use Trudhesa if you:
- Have any disease affecting your heart, arteries, or blood circulation
- Are taking certain anti-HIV medications known as protease inhibitors (such as ritonavir or nelfinavir)
- Are taking a macrolide antibiotic such as clarithromycin or erythromycin
- Are taking certain antifungals such as ketoconazole or itraconazole
- Have taken certain medications such as triptans or ergot-type medications for the treatment or prevention of migraine within the last 24 hours
- Have taken any medications that constrict your blood vessels or raise your blood pressure
- Have severe liver or kidney disease
- Are allergic to ergotamine or dihydroergotamine
Before taking Trudhesa, tell your doctor if:
- You have high blood pressure, chest pain, shortness of breath, heart disease; or risk factors for heart disease (such as high blood pressure, high cholesterol, obesity, diabetes, smoking, strong family history of heart disease or you are postmenopausal, or male over 40); or problems with blood circulation in your arms, legs, fingers, or toes.
- You have or had any disease of the liver or kidney.
- You are taking any prescription or over-the-counter medications, including vitamins or herbal supplements.
- You are pregnant, planning to become pregnant or are nursing, or have ever stopped medication due to an allergy or bad reaction.
- This headache is different from your usual migraine attacks.
The use of Trudhesa should not exceed dosing guidelines and should not be used on a daily basis.
Serious cardiac (heart) events, including some that have been fatal, have occurred following the use of dihydroergotamine mesylate, particularly with dihydroergotamine for injection, but are extremely rare.
You may experience some nasal congestion or irritation, altered sense of taste, sore throat, nausea, vomiting, dizziness, and fatigue after using Trudhesa.
Contact your doctor immediately if you experience:
- Numbness or tingling in your fingers and toes
- Severe tightness, pain, pressure, heaviness, or discomfort in your chest
- Muscle pain or cramps in your arms or legs
- Cold feeling or color changes in 1 or both legs or feet
- Sudden weakness
- Slurred speech
- Swelling or itching
The risk information provided here is not comprehensive. To learn more, talk about Trudhesa with your healthcare provider or pharmacist. The FDA-approved product labeling can be found at www.trudhesa.com or 1-800-555-DRUG. You can also call 1-833-TRUDHESA (1-833-878-3437) for additional information.
About Impel NeuroPharma
Impel NeuroPharma, Inc. is a commercial-stage biopharmaceutical company developing transformative therapies for people suffering from diseases with high unmet medical needs, with an initial focus on diseases of the central nervous system. Impel offers and is developing treatments that pair its proprietary Precision Olfactory Delivery (POD®) technology with well-established therapeutics. In addition to Trudhesa™ (dihydroergotamine mesylate) nasal spray, which is approved in the United States for the acute treatment of migraine with or without aura in adults, Impel is also developing INP105 for the acute treatment of agitation and aggression in patients with autism, and INP107 for OFF episodes in Parkinson's disease.Impel, POD, Trudesa and Trudhesa Direct are trademarks of Impel NeuroPharma, Inc.
About Phil, Inc:
Phil is a software therapy deployment platform, offering pharmaceutical manufacturers a modern alternative to traditional access, affordability and distribution options. Through its digital stakeholder experiences, patient access services, market access solutions and distribution models, pharma manufacturers are able to deliver affordable and timely therapy access to patients. For more information on Phil, visit phil.us.Contact Phil at: https://phil.us/manufacturers
i Impel Neuropharma. (2020). INP104-301. Table 3.8.2.
View original content to download multimedia:https://www.prnewswire.com/news-releases/phil-announces-partnership-with-impel-neuropharma-in-support-of-trudhesa-dihydroergotamine-mesylate-nasal-spray-for-the-acute-treatment-of-migraine-301388325.htmlSOURCE Phil Inc.
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SCHAUMBURG, Ill., Sept. 28, 2021 /PRNewswire/ -- Carepoint Pharmacy announces that it will partner with Impel NeuroPharma, Inc. (NASDAQ: IMPL) to begin dispensing Trudhesa™ (dihydroergotamine mesylate) nasal spray (0.725 mg per spray) for the acute treatment of migraine with or without aura in adults. Trudhesa, approved by the U.S. Food and Drug Administration (FDA) on September 2, 2021, uses Impel's proprietary Precision Olfactory Delivery (POD®) technology to gently deliver dihydroergotamine mesylate (DHE)—a proven, well-established therapeutic—quickly to the bloodstream through the vascular-rich upper nasal space. Trudhesa bypasses the gut and potential absorption issues, offering rapid, sustained, and consistent symptom relief without injection or infusion, even when administered hours after the onset of a migraine attack.
Carepoint Pharmacy's unique end-to-end digital pharmacy solutions will support people with migraine throughout the country through this partnership. Carepoint Pharmacy is only one of two digital pharmacies selected to dispense Trudhesa as part of a limited distribution network.
"Our company was built to provide patients with a simple and patient-first pharmacy experience that makes getting prescriptions easy, fast and reliable. When you're dealing with the unpredictability of a condition like migraine, we offer assurance that your medication will arrive quickly, straight to your home, for convenience you can trust," said Bhavesh Patel, PharmD, Chief Executive Officer, Carepoint Pharmacy.
"At Impel, the needs of patients drive our quest to innovate and when we seek our partners, we look for those who put patients first," said Adrian Adams, Chairman and Chief Executive Officer, Impel NeuroPharma. "Today, we are thrilled to partner with Carepoint Pharmacy to make Trudhesa available to people with migraine via Trudhesa Direct™, providing an option that offers the rapid, sustained, and consistent relief they are looking for. Eligible, commercially-insured patients are automatically enrolled in a savings program and the medication is shipped straight to their home at no additional cost. Together with Carepoint Pharmacy, we look forward to providing an unparalleled experience for people with migraine who choose Trudhesa for symptom relief."
Trudhesa Indication and Important Safety Information
Indication
Trudhesa is used to treat an active migraine headache with or without aura in adults. Do not use Trudhesa to prevent migraine when you have no symptoms. It is not known if Trudhesa is safe and effective in children.
Important Safety Information
Serious or potentially life-threatening reductions in blood flow to the brain or extremities due to interactions between dihydroergotamine (the active ingredient in Trudhesa) and strong CYP3A4 inhibitors (such as protease inhibitors and macrolide antibiotics) have been reported rarely. As a result, these medications should not be taken together.
Do not use Trudhesa if you:
- Have any disease affecting your heart, arteries, or blood circulation
- Are taking certain anti-HIV medications known as protease inhibitors (such as ritonavir or nelfinavir)
- Are taking a macrolide antibiotic such as clarithromycin or erythromycin
- Are taking certain antifungals such as ketoconazole or itraconazole
- Have taken certain medications such as triptans or ergot-type medications for the treatment or prevention of migraine within the last 24 hours
- Have taken any medications that constrict your blood vessels or raise your blood pressure
- Have severe liver or kidney disease
- Are allergic to ergotamine or dihydroergotamine
Before taking Trudhesa, tell your doctor if:
- You have high blood pressure, chest pain, shortness of breath, heart disease; or risk factors for heart disease (such as high blood pressure, high cholesterol, obesity, diabetes, smoking, strong family history of heart disease or you are postmenopausal, or male over 40); or problems with blood circulation in your arms, legs, fingers, or toes.
- You have or had any disease of the liver or kidney.
- You are taking any prescription or over-the-counter medications, including vitamins or herbal supplements.
- You are pregnant, planning to become pregnant or are nursing, or have ever stopped medication due to an allergy or bad reaction.
- This headache is different from your usual migraine attacks.
The use of Trudhesa should not exceed dosing guidelines and should not be used on a daily basis.
Serious cardiac (heart) events, including some that have been fatal, have occurred following the use of dihydroergotamine mesylate, particularly with dihydroergotamine for injection, but are extremely rare.
You may experience some nasal congestion or irritation, altered sense of taste, sore throat, nausea, vomiting, dizziness, and fatigue after using Trudhesa.
Contact your doctor immediately if you experience:
- Numbness or tingling in your fingers and toes
- Severe tightness, pain, pressure, heaviness, or discomfort in your chest
- Muscle pain or cramps in your arms or legs
- Cold feeling or color changes in 1 or both legs or feet
- Sudden weakness
- Slurred speech
- Swelling or itching
The risk information provided here is not comprehensive. To learn more, talk about Trudhesa with your healthcare provider or pharmacist. The FDA-approved product labeling can be found at www.trudhesa.com or 1-800-555-DRUG. You can also call 1-833-TRUDHESA (1-833-878-3437) for additional information.
About Impel NeuroPharma
Impel NeuroPharma, Inc. is a commercial-stage biopharmaceutical company developing transformative therapies for people suffering from diseases with high unmet medical needs, with an initial focus on diseases of the central nervous system. Impel offers and is developing treatments that pair its proprietary Precision Olfactory Delivery (POD®) technology with well-established therapeutics. In addition to Trudhesa™ (dihydroergotamine mesylate) nasal spray, which is approved in the United States for the acute treatment of migraine with or without aura in adults, Impel is also developing INP105 for the acute treatment of agitation and aggression in patients with autism, and INP107 for OFF episodes in Parkinson's disease.Imple, POD, Trudhesa, and Trudhesa Direct are trademarks of Impel NeuroPharma, Inc. To learn more about Impel NeuroPharma, please visit https://impelnp.com/.
About Carepoint Pharmacy
Carepoint Pharmacy is a full-service, digital pharmacy that offers prescription fulfillment and delivery to patients in all 50 states and Washington D.C. With six owned and operated pharmacies, Carepoint's accreditations include URAC Mail Order Pharmacy, URAC Specialty Pharmacy, and NABP Digital Pharmacy. To learn more about Carepoint Pharmacy, please visit https://carepoint.pharmacy/.Media Contact:
Pritesh Patel
[email protected]
855-237-9112SOURCE Carepoint Pharmacy
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