Aquestive Therapeutics Inc. (AQST) Receives Positive FDA Written Response for AQST-109 Epinephrine Sublingual Film

Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company advancing current standards of care to solve patients’ problems through simplifying complex delivery methods, today announced positive written feedback from the U.S. Food and Drug Administration (FDA) for its initial End-of-Phase 2 (EoP2) meeting request to discuss Chemistry, Manufacturing, and Controls (CMC) for its AQST-109 epinephrine sublingual film for the treatment of severe allergic reaction including anaphylaxis.

On August 2, 2022, Aquestive requested an EoP2 meeting to obtain guidance and/or concurrence on specific questions relating to both drug substance and drug product characterization, control, and stability for its drug candidate AQST-109 epinephrine sublingual film. In lieu of a meeting, the FDA provided a formal written response to the Company’s questions.

“We are excited by the FDA’s written response confirming our approach and supporting the characterization of our novel drug platform – a factor that will accompany our NDA filing for this product,” said Daniel Barber, Chief Executive Officer of Aquestive. “The positive Agency response reinforces our development plans and approach as we continue to progress the AQST-109 program, including in critical areas such as assigning shelf life. We are looking forward to our next scheduled interaction with the FDA later this quarter where we will discuss the results of our EPIPHAST studies and our clinical development plan.”

Stability and shelf life are well-documented topics for acute rescue products containing epinephrine. Epinephrine is known to degrade quickly and, as the EpiPen® label currently indicates, “[e]pinephrine solution deteriorates rapidly on exposure to air or light.” AQST-109 has been designed to minimize exposure to air and light until opened for use. The FDA’s written response indicates that Aquestive’s approach to characterizing these and other attributes of AQST-109 “appear reasonable” in the context of a potential future filing.

Aquestive has also requested an EoP2 meeting with the FDA to obtain guidance and/or concurrence on specific questions relating to the clinical components of a potential AQST-109 filing. At this meeting, Aquestive anticipates receiving feedback on its EPIPHAST study data as well as the proposed clinical development plan for AQST-109. This meeting has been granted by the FDA and is scheduled to occur prior to the end of 2022.

About AnaphylaxisAnaphylaxis is a serious systemic hypersensitivity reaction with rapid onset and potentially fatal. As many 49 million people in the United States are at chronic risk for acute anaphylactic episodes. Lifetime prevalence may be higher than 5%. Chronic allergic illness costs the US healthcare system more than $18 billion annually. The frequency of hospital admissions for anaphylaxis has increased 500-700% in the last 10-15 years. 52% of patients, who had previously experienced anaphylaxis, had never received an epinephrine autoinjector prescription, and 60% did not have an autoinjector currently available. The most common causes of reactions that can include anaphylaxis are medications, foods (such as peanuts), and venom from insect stings. Epinephrine injection is the current standard of treatment intended to reverse the potentially severe manifestation of anaphylaxis, which may include red rash, throat swelling, respiratory problems, gastrointestinal distress, and loss of consciousness.

You May Also Be Interested In

• Indivior's (INDV) SUBLOCADE Rapid Induction/Alternative Injection Site Prior Approval Supplement (PAS) Receives FDA Priority Review
• Inozyme Pharma Inc. (INZY) Appoints Erik Harris to its Board
• Quantum BioPharma (QNTM) Provides Update from Celly Nutrition Signing a Master Distribution Agreement with FUSION Distribution Group across Puerto Rico, The Caribbean, and Parts of Central and South A