Aquestive’s Anaphylm™ Sublingual Film Receives FDA Priority review for Anaphylaxis Treatment
Table of Contents
- Aquestive’s Anaphylm™ Sublingual Film Receives FDA Priority review for Anaphylaxis Treatment
- Anaphylm™: A Novel Approach to Anaphylaxis Treatment
- Clinical Data and Potential Impact
- Key Features of Anaphylm™
- Aquestive Therapeutics: advancing Patient Care
- Financial Outlook and Forward-looking Statements
- Summary of Anaphylm™ Development
- Evergreen Insights: Understanding Anaphylaxis and its Treatment
- Frequently Asked Questions About Anaphylm™
Aquestive Therapeutics, Inc. (NASDAQ:
AQST) announced that the U.S.Food and Drug Administration (FDA) has accepted its new Drug Application (NDA) for Anaphylm™ (epinephrine) Sublingual Film, a potential breakthrough treatment for anaphylaxis. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 31,2026.If approved, Anaphylm™ would be the first and only device-free, orally delivered epinephrine medicine, offering a novel choice to traditional injectable treatments.
Anaphylm™: A Novel Approach to Anaphylaxis Treatment
Anaphylm™ is designed to address critical barriers to anaphylaxis treatment, primarily the fear of injections and the inconvenience of carrying bulky devices. The sublingual film, about the size of a postage stamp, dissolves rapidly upon contact with saliva, eliminating the need for water or swallowing. Its packaging is thinner than a credit card, making it easily portable in a pocket, wallet, or phone case.
Did You Know? Anaphylaxis affects up to 5% of the U.S.population,and epinephrine is the first-line treatment.
According to a study published in the Journal of Allergy and Clinical Immunology, approximately 30% of individuals with known allergies do not carry epinephrine auto-injectors.
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This highlights the urgent need for more accessible and convenient treatment options.
Clinical Data and Potential Impact
Clinical data has demonstrated Anaphylm’s ability to rapidly deliver epinephrine absorption orally. The acceptance of the NDA by the FDA marks a notable step toward making this life-saving innovation available to patients and caregivers.
Dr. David Stukus, M.D., Professor of Clinical Pediatrics and Director of the Food Allergy Treatment Center at Nationwide Children’s Hospital and The Ohio State University College of medicine, emphasized the importance of availability and ease of use. “Epinephrine can only save lives if people have it available and feel confident using it promptly,” he stated. “This potential drug product addresses the two biggest barriers we hear from patients – fear of administration and the inconvenience of carrying bulky devices. An oral, no-needle approach could be transformative for anaphylaxis care.”
Key Features of Anaphylm™
- Device-Free: Eliminates the need for needles or bulky auto-injectors.
- Oral Delivery: Sublingual film dissolves quickly without water.
- Highly Portable: Thinner than a credit card,easily fits in a pocket or wallet.
- Weather-Resistant Packaging: designed to withstand exposure to rain and sunlight.
Aquestive Therapeutics: advancing Patient Care
Aquestive Therapeutics is dedicated to improving patient lives through innovative science and delivery technologies. The company develops orally administered products to deliver complex molecules,providing novel alternatives to invasive and inconvenient standard-of-care therapies. Aquestive has several commercialized products marketed by its licensees globally and collaborates with pharmaceutical companies to bring new molecules to market using proprietary technologies like PharmFilm®.
Pro Tip: Patients should always consult with their healthcare provider to determine the most appropriate treatment plan for anaphylaxis.
Financial Outlook and Forward-looking Statements
The development and potential approval of Anaphylm™ represent a significant milestone for Aquestive Therapeutics. However, the company’s press release includes forward-looking statements that are subject to risks and uncertainties. these include potential delays or changes in clinical trials, regulatory approval processes, and the commercialization of new products. Investors are advised to review the company’s filings with the U.S. Securities and Exchange Commission for a comprehensive understanding of these risks.
Summary of Anaphylm™ Development
| Milestone | Date | Details |
|---|---|---|
| NDA Submission | 2025 | Aquestive therapeutics submits new Drug Application to FDA for Anaphylm™. |
| FDA Acceptance | June 2025 | FDA accepts NDA and grants priority review. |
| PDUFA Target Action Date | January 31, 2026 | FDA sets target date for decision on Anaphylm™ approval. |
| Potential Approval | January 2026 (if approved) | Anaphylm™ could become the first device-free, orally delivered epinephrine medicine. |
Evergreen Insights: Understanding Anaphylaxis and its Treatment
Anaphylaxis is a severe, potentially life-threatening allergic reaction that can occur within minutes of exposure to an allergen. Common triggers include food, insect stings, medications, and latex. Symptoms can range from hives and swelling to difficulty breathing and a sudden drop in blood pressure. Epinephrine,also known as adrenaline,is the first-line treatment for anaphylaxis,working to reverse the symptoms by constricting blood vessels,relaxing airway muscles,and stimulating the heart.
The current standard of care involves epinephrine auto-injectors, which deliver a pre-measured dose of epinephrine via intramuscular injection. However, these devices can be intimidating for some patients, leading to hesitation in their use. Furthermore, the size and bulk of auto-injectors can make them inconvenient to carry, resulting in many individuals not having access to life-saving medication when needed.
The development of alternative epinephrine delivery methods, such as sublingual films, aims to address these challenges and improve patient adherence to carrying and using epinephrine. By offering a more convenient and user-friendly option, these innovations have the potential to significantly reduce the morbidity and mortality associated with anaphylaxis.
Frequently Asked Questions About Anaphylm™
What are the potential side effects of Anaphylm™?
As with any medication, Anaphylm™ may have potential side effects.Common side effects of epinephrine can include anxiety, dizziness, increased heart rate, and palpitations. Patients should discuss potential side effects with their healthcare provider before using Anaphylm™.
How should Anaphylm™ be stored?
Anaphylm™ is designed with weather-resistant packaging to withstand exposure to rain and sunlight. Though, it should still be stored according to the manufacturer’s instructions to ensure its effectiveness.
Is Anaphylm™ suitable for all patients with anaphylaxis?
Anaphylm™ may not be suitable for all patients with anaphylaxis. Patients should consult with their healthcare provider to determine if Anaphylm™ is the right treatment option for them based on their individual medical history and needs.
How does Anaphylm™ compare to existing epinephrine auto-injectors?
Anaphylm™ offers a device-free, orally delivered alternative to epinephrine auto-injectors. It eliminates the need for injections and is designed to be more convenient and portable. However, it is essential to consult with a healthcare provider to determine the most appropriate treatment option.
What should I do if I experience anaphylaxis symptoms?
If you experience symptoms of anaphylaxis, use your epinephrine medication immediately and seek emergency medical attention.Even if symptoms improve after using epinephrine,it is crucial to go to the nearest emergency room for further evaluation and treatment.
What are your thoughts on this potential new treatment option for anaphylaxis? How might this impact your or your loved ones’ lives? Share your comments below!