This section highlights FDA-related milestones and regulatory updates for drugs developed by Aquestive Therapeutics (AQST).
Over the past two years, Aquestive Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Anaphylm, epinephrine, and Libervant. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Anaphylm - FDA Regulatory Timeline and Events
Anaphylm is a drug developed by Aquestive Therapeutics for the following indication: For epinephrine prodrug candidate product.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Anaphylm
- Announced Date:
- June 25, 2025
- Indication:
- For epinephrine prodrug candidate product
Announcement
Aquestive Therapeutics, Inc announced that two poster presentations highlighting results from the investigational use of Anaphylm™ (epinephrine) Sublingual Film in the treatment of severe allergic reactions, including anaphylaxis, will be presented at the Center for Food Allergy and Asthma Research (CFAAR) Food Allergy Summit , which will be held June 27-29 in Chicago, Ill.
AI Summary
Aquestive Therapeutics, Inc. announced that two poster presentations will feature data on the investigational use of Anaphylm™ (epinephrine) Sublingual Film for treating severe allergic reactions, including anaphylaxis. These posters will be presented at the Center for Food Allergy and Asthma Research (CFAAR) Food Allergy Summit in Chicago, Illinois, from June 27-29, 2025. Scheduled for June 28 between 5:00 PM and 7:30 PM CST, one poster highlights the film’s physicochemical stability under extreme temperatures, while the other details its rapid and consistent pharmacokinetic and pharmacodynamic responses.
Anaphylm is an innovative, polymer matrix-based epinephrine prodrug designed for easy, water-free administration. If approved by the U.S. Food and Drug Administration, it would become the first and only oral epinephrine option for severe allergic reaction treatment in the United States.
Read Announcement- Drug:
- Anaphylm
- Announced Date:
- June 16, 2025
- Estimated Event Date Range:
- January 31, 2026 - January 31, 2026
- Target Action Date:
- January 31, 2026
- Indication:
- For epinephrine prodrug candidate product
Announcement
Aquestive Therapeutics, Inc. announced that FDA assigns PDUFA target action date of January 31, 2026
AI Summary
Aquestive Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for Anaphylm™, a novel treatment for severe allergic reactions such as anaphylaxis. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of January 31, 2026, meaning it aims to complete its review by that time. This date marks an important milestone as the agency evaluates whether Anaphylm can become an approved, convenient oral option for epinephrine delivery.
If approved, Anaphylm would be the first orally delivered epinephrine treatment available in the United States, potentially replacing bulky, device-based alternatives. Aquestive Therapeutics believes that this innovative approach will help patients manage life-threatening allergic reactions more easily and reliably, fitting smoothly into their everyday lives.
Read Announcement - Drug:
- Anaphylm
- Announced Date:
- June 16, 2025
- Indication:
- For epinephrine prodrug candidate product
Announcement
Aquestive Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's New Drug Application (NDA) for Anaphylm™ in the treatment of Type 1 allergic reactions, including anaphylaxis
AI Summary
Aquestive Therapeutics, Inc. announced that the FDA has accepted its New Drug Application (NDA) for Anaphylm™, a treatment for Type 1 allergic reactions, including anaphylaxis. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of January 31, 2026, for its review. If approved, Anaphylm will become the first and only orally delivered epinephrine option, offering a groundbreaking, device-free solution for managing severe allergic reactions. Designed to be as thin as a credit card, this innovative product can easily fit in a phone case, wallet, or pocket and does not require special storage conditions. With clinical data showing rapid epinephrine absorption, Anaphylm aims to overcome challenges associated with conventional epinephrine treatments, potentially providing patients with a more accessible and convenient method of administration during allergic emergencies.
Read Announcement- Drug:
- Anaphylm
- Announced Date:
- February 12, 2025
- Indication:
- For epinephrine prodrug candidate product
Announcement
Aquestive Therapeutics, Inc. announced that multiple presentations highlighting results from the investigational use of Anaphylm epinephrine sublingual film in the treatment of severe allergic reactions, including anaphylaxis, will be featured at the 2025 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting.
AI Summary
Aquestive Therapeutics announced that results from investigational studies using its Anaphylm epinephrine sublingual film to treat severe allergic reactions, including anaphylaxis, will be showcased at the 2025 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting in San Diego. The presentations will detail how Anaphylm delivers consistent epinephrine absorption and reliable pharmacokinetic and pharmacodynamic responses. Data from the studies showed that patients experienced a median symptom resolution time of 12 minutes, compared to 74 minutes without treatment, and rapid improvement in angioedema symptoms. Additionally, findings highlighted that Anaphylm maintains its stability and potency under real-world conditions such as extreme temperatures, freezing, and water submersion. These results support Anaphylm’s potential as a portable, non-injectable treatment option for managing life-threatening allergic reactions.
Read Announcement- Drug:
- Anaphylm
- Announced Date:
- December 2, 2024
- Indication:
- For epinephrine prodrug candidate product
Announcement
Aquestive Therapeutics, Inc announced receipt of positive feedback from the U.S. Food and Drug Administration (FDA) prior to its planned NDA submission for Anaphylm™ (epinephrine) Sublingual Film.
AI Summary
Aquestive Therapeutics, Inc. received positive feedback from the U.S. Food and Drug Administration (FDA) regarding its plans for submitting a New Drug Application (NDA) for its Anaphylm™ (epinephrine) Sublingual Film. The FDA agreed with the planned content and format of the NDA submission, noting that no additional adult clinical trials are required before filing. The agency also provided guidance on including extra data views, especially focusing on pharmacokinetic sustainability for a single dose, and suggested minor modifications for the pediatric trial, which the company has already addressed without expecting any delays. Anaphylm, if approved, could be the first and only epinephrine product delivered by a simple sublingual film, offering a potential new treatment option for severe allergic reactions, including anaphylaxis, and presenting a transformative alternative to traditional epinephrine medical devices.
Read Announcement- Drug:
- Anaphylm
- Announced Date:
- July 25, 2024
- Indication:
- For epinephrine prodrug candidate product
Announcement
Aquestive Therapeutics, Inc today released positive topline PK data from the self-administration study of Anaphylm™ (epinephrine) Sublingual Film. Anaphylm has the potential to be the first and only non-invasive, orally delivered epinephrine for the treatment of severe life-threatening allergic reactions, including anaphylaxis, if approved by the United States Food and Drug Administration (FDA).
AI Summary
Aquestive Therapeutics, Inc. announced positive topline pharmacokinetic (PK) results from its self-administration study of Anaphylm™ (epinephrine) Sublingual Film. The study demonstrated that when Anaphylm is self-administered, its PK profile is comparable to when a healthcare provider administers it. Both administration methods achieved rapid and substantial epinephrine absorption, with the median time to maximum concentration—15 minutes—significantly faster than the 50 minutes seen with traditional intramuscular injections. This data supports Anaphylm’s potential as the first non-invasive, orally delivered epinephrine treatment for severe allergic reactions, including anaphylaxis. The ease of use, portability, and needle-free design make it especially promising for real-world emergency situations where quick and effective self-administration is critical, pending FDA approval.
Read Announcement- Drug:
- Anaphylm
- Announced Date:
- July 25, 2024
- Estimated Event Date Range:
- July 1, 2024 - September 30, 2024
- Target Action Date:
- Q3 2024
- Indication:
- For epinephrine prodrug candidate product
Announcement
Aquestive Therapeutics, Inc announced that the company Continues to anticipate requesting a pre-New Drug Application (NDA) meeting before the end of the third quarter
AI Summary
Aquestive Therapeutics, Inc announced that it continues to anticipate requesting a pre-New Drug Application (NDA) meeting with the FDA before the end of the third quarter. The company is developing its innovative Anaphylm Sublingual Film, which could become the first non-invasive, orally delivered epinephrine treatment for severe allergic reactions, including anaphylaxis. Recent study results showed that epinephrine absorption is similar whether the medication is self-administered or given by a healthcare provider, demonstrating the product’s potential for rapid and reliable action in emergency situations.
This upcoming pre-NDA meeting is a critical step as Aquestive moves forward with clinical studies and regulatory planning. The company’s strategy is to gather the necessary data and file its NDA soon, aiming for a full product launch by late 2025 or early 2026, which has caught the attention of both patients and industry experts.
Read Announcement- Drug:
- Anaphylm
- Announced Date:
- June 25, 2024
- Estimated Event Date Range:
- July 1, 2024 - September 30, 2024
- Target Action Date:
- Q3 2024
- Indication:
- For epinephrine prodrug candidate product
Announcement
Aquestive Therapeutics, Inc announced that it Remains on track to complete Anaphylm supportive clinical studies and expects to request pre-NDA meeting with FDA in the third quarter 2024
AI Summary
Aquestive Therapeutics, Inc. announced it remains on track to complete supportive clinical studies for its product candidate, Anaphylm Sublingual Film, designed to treat severe allergic reactions such as anaphylaxis. The company plans to request a pre-NDA meeting with the FDA in the third quarter of 2024, anticipating that the supportive adult study results will strengthen its New Drug Application filing shortly after completion of its pediatric study.
The advancement of these studies supports the goal of providing a non-invasive, easy-to-carry epinephrine treatment that performs consistently regardless of liquid temperature or pH. Aquestive believes that the data and upcoming clinical milestones will help demonstrate Anaphylm’s potential as a reliable alternative to traditional autoinjectors, addressing an important unmet need in the severe allergy community.
Read Announcement- Drug:
- Anaphylm
- Announced Date:
- June 25, 2024
- Indication:
- For epinephrine prodrug candidate product
Announcement
Aquestive Therapeutics, Inc announced that Continues to anticipate filing a New Drug Application (NDA) shortly after completion of its pediatric study of Anaphylm
AI Summary
Aquestive Therapeutics, Inc. announced a key milestone in advancing its product candidate, Anaphylm™ (epinephrine) Sublingual Film. The company stated it continues to anticipate filing a New Drug Application (NDA) shortly after completing its pediatric study. This study, scheduled for the fourth quarter of 2024 pending agreement with the FDA, is designed to further evaluate the safety and effectiveness of Anaphylm for young patients.
Additionally, Aquestive plans to request a pre-NDA meeting with the FDA once topline data from other supportive clinical studies is received. This strategic approach aims to strengthen the overall clinical program and move the product closer to approval. Anaphylm is being developed as an easy-to-carry, non-invasive treatment for severe allergic reactions, offering a promising new option for patients who risk life-threatening anaphylaxis.
Read Announcement- Drug:
- Anaphylm
- Announced Date:
- June 25, 2024
- Indication:
- For epinephrine prodrug candidate product
Announcement
Aquestive Therapeutics, Inc. today released positive topline pharmacokinetic (PK) data from the temperature / pH study of its product candidate Anaphylm™ (epinephrine) Sublingual Film.
AI Summary
Aquestive Therapeutics, Inc. announced positive topline pharmacokinetic (PK) data from its temperature and pH study evaluating Anaphylm™ (epinephrine) Sublingual Film. The study tested how different liquids—such as hot water, cold water, acidic lemon water, and alkaline baking soda water—affect the PK profile of the product. Results showed no statistically significant differences in the maximum concentration (Cmax) and overall exposure (AUC) of epinephrine when compared with room temperature water, suggesting that the film’s performance is stable under varied conditions. This finding supports Anaphylm’s potential to be easily incorporated into daily routines for patients at risk of severe allergic reactions. The company is moving forward with its supportive clinical studies and expects to request a pre-New Drug Application meeting with the FDA in the third quarter of 2024, paving the way for future regulatory steps.
Read Announcement- Drug:
- Anaphylm
- Announced Date:
- May 28, 2024
- Indication:
- For epinephrine prodrug candidate product
Announcement
Aquestive Therapeutics, Inc. announced that two encore poster presentations highlighting the positive pharmacokinetic (PK) and pharmacodynamic (PD) data from two completed clinical studies for Anaphylm™ (epinephrine) sublingual film will be presented at the Eastern Allergy Conference (EAC).
AI Summary
Aquestive Therapeutics, Inc. announced that two encore poster presentations will showcase positive pharmacokinetic (PK) and pharmacodynamic (PD) data from two completed clinical studies for its Anaphylm™ (epinephrine) sublingual film. These posters will be presented at the Eastern Allergy Conference (EAC), held from May 30 to June 2, 2024, in Palm Beach, Florida. One poster, led by Dr. Gary Slatko, focuses on PD results comparing sublingual film administration with traditional methods like manual injections and auto-injectors. The second presentation, headed by Dr. David Golden, reviews both PK and PD data. The findings highlight Anaphylm’s potential to transform the treatment of severe allergic reactions, including anaphylaxis, offering a convenient, orally administered alternative to current emergency treatments.
Read Announcement
epinephrine - FDA Regulatory Timeline and Events
epinephrine is a drug developed by Aquestive Therapeutics for the following indication: Topical Gel for the treatment of Alopecia areata.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- epinephrine
- Announced Date:
- April 1, 2025
- Indication:
- Topical Gel for the treatment of Alopecia areata
Announcement
Aquestive Therapeutics, Inc released topline results from its pediatric study for Anaphylm (epinephrine) sublingual film in patients aged seven to seventeen and weighing over 30 kgs with a personal history of allergic reactions.
AI Summary
Aquestive Therapeutics, Inc. announced positive topline results from its pediatric study for Anaphylm™ (epinephrine) sublingual film. The study evaluated the treatment in patients aged seven to seventeen who weighed over thirty kilograms and had a personal history of allergic reactions. The data showed that Anaphylm has a consistent pharmacokinetic profile in this group, similar to results seen in adult studies. Moreover, the study demonstrated that the treatment is safe and well-tolerated, with no serious adverse events reported. These positive outcomes are a crucial part of the data being submitted in the New Drug Application (NDA) to the FDA. If the application is accepted—expected in the second quarter of 2025—it could lead to a broader label for pediatric use and contribute to providing a convenient, non-invasive option for patients facing severe allergic reactions.
Read Announcement- Drug:
- epinephrine
- Announced Date:
- September 27, 2024
- Indication:
- Topical Gel for the treatment of Alopecia areata
Announcement
Aquestive Therapeutics today hosted a virtual investor day highlighting the Company's pipeline inclusive of Anaphylm™ (epinephrine) Sublingual Film and AQST-108 (epinephrine) Topical Gel, both product candidates emerging from the Company's Adrenaverse™ epinephrine prodrug platform.
AI Summary
Aquestive Therapeutics hosted a virtual investor day to showcase its innovative product pipeline. The company highlighted two key product candidates emerging from its Adrenaverse epinephrine prodrug platform. The first candidate is Anaphylm™ (epinephrine) Sublingual Film, a fast-dissolving film designed to quickly manage severe allergic reactions without the need for water or swallowing. The film’s compact design makes it easy to carry and ensures proper administration even in challenging conditions.
The second product candidate is AQST-108 (epinephrine) Topical Gel, which is being developed to support treatments such as Alopecia areata. This gel is designed to deliver epinephrine directly to the skin, allowing for sustained local exposure while minimizing systemic effects. Company executives and experts discussed the promising potential of these therapies to improve epinephrine delivery and address critical unmet medical needs.
Read Announcement
Libervant (diazepam) - FDA Regulatory Timeline and Events
Libervant (diazepam) is a drug developed by Aquestive Therapeutics for the following indication: Epileptic seizures.
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Libervant (diazepam)
- Announced Date:
- January 13, 2025
- Indication:
- Epileptic seizures
Announcement
Aquestive Therapeutics, Inc provided an update on recent business developments and outlined key objectives for 2025.
AI Summary
Aquestive Therapeutics, Inc. recently updated investors on its latest business developments and shared key objectives for 2025. The company is focused on positioning its innovative pipeline for future success. One major goal is to prepare for the submission of the New Drug Application for its Anaphylm (epinephrine) Sublingual Film in the first quarter of 2025, aiming to address unmet needs in severe allergy management.
Additional objectives include advancing its global development strategy for Anaphylm and initiating a Phase 2a clinical trial for AQST-108 in patients with alopecia areata. Aquestive is also working to increase sales of its Libervant buccal film for pediatric patients and shifting its revenue streams from legacy products to newer growth opportunities. These initiatives reflect the company's commitment to innovative science and improving patient care going forward.
Read Announcement- Drug:
- Libervant (diazepam)
- Announced Date:
- December 19, 2024
- Indication:
- Epileptic seizures
Announcement
Aquestive Therapeutics, Inc. announced the U.S. Food and Drug Administration (FDA) has granted seven years of orphan drug exclusivity (ODE) to Libervant® (diazepam) Buccal Film for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy between two to five years of age.
AI Summary
Aquestive Therapeutics announced that the FDA has granted seven years of orphan drug exclusivity for Libervant® (diazepam) Buccal Film. This designation is for its use in treating intermittent, stereotypic episodes of frequent seizure activity, known as seizure clusters, in pediatric epilepsy patients ages 2 to 5. The exclusivity highlights the FDA’s recognition that the buccal administration of Libervant® offers a significant improvement in ease of use compared to traditional rectal methods. As the first and only orally administered rescue therapy for this age group, Libervant® provides a non-invasive treatment option that can be vital during acute seizure events. This market exclusivity, valid until April 2031, supports further development and access, ensuring that young patients and their caregivers benefit from this innovative and user-friendly treatment option during emergency situations.
Read Announcement- Drug:
- Libervant (diazepam)
- Announced Date:
- April 29, 2024
- Indication:
- Epileptic seizures
Announcement
Aquestive Therapeutics, Inc. announced the U.S. Food and Drug Administration (FDA) has approved Libervant™ (diazepam) Buccal Film for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy between 2 to 5 years of age.
AI Summary
Aquestive Therapeutics recently received FDA approval for Libervant™ (diazepam) Buccal Film, a new treatment for acute seizure clusters in young children. The FDA authorized its use in patients with epilepsy ages 2 to 5 who experience intermittent, stereotypic episodes of frequent seizure activity that differ from their usual pattern. Libervant is unique as the first orally administered rescue medication available for this age group, offering a convenient and effective alternative to device-based treatments like rectal gels. The film is applied to the inside of the cheek, where it dissolves quickly and delivers a consistent dose of diazepam, helping to manage acute repetitive seizures. Aquestive emphasized its commitment to making Libervant immediately available for non-Medicaid prescriptions and plans to expand its distribution in the coming weeks to better serve this vulnerable patient population.
Read Announcement- Drug:
- Libervant (diazepam)
- Announced Date:
- April 12, 2024
- Indication:
- Epileptic seizures
Announcement
Aquestive Therapeutics, Inc. announced a poster presentation highlighting the crossover study for the Company's product candidate, Libervant™ (diazepam) Buccal Film for treatment of children with epilepsy aged two to five, will be presented at the 76th Annual Meeting of the American Academy of Neurology (AAN) in Denver from April 13 to 18, offering both in-person attendance and live online participation in a hybrid format.
AI Summary
Aquestive Therapeutics, Inc. is set to share key clinical findings at the 76th Annual Meeting of the American Academy of Neurology in Denver from April 13 to 18. The company will present a poster detailing a crossover study on its product candidate, Libervant™ (diazepam) Buccal Film. This innovative study examines how seizures may affect the absorption of diazepam from a film designed to treat children with epilepsy aged two to five.
The presentation, scheduled for April 17, will be accessible in a hybrid format, allowing both in-person attendance and live online participation. Libervant aims to provide a less invasive, oral alternative to device-based products currently used to manage seizure clusters in young pediatric patients, showcasing a promising step forward in pediatric epilepsy care.
Read Announcement
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