AQST - Aquestive Therapeutics receives positive FDA response for AQST-109 epinephrine for severe allergic reaction
- Aquestive Therapeutics ( NASDAQ: AQST ) said on Tuesday it had received positive feedback from the U.S. Food and Drug Administration for its initial End-of-Phase 2 (EoP2) meeting request to discuss Chemistry, Manufacturing, and Controls for its AQST-109 epinephrine sublingual film to treat severe allergic reaction including anaphylaxis.
- ( AQST ) has risen ~3% premarket.
- "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," the company said.
- The company's drug, AQST-109, has been designed to minimize exposure to air and light until opened for use.
- 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.
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Aquestive Therapeutics receives positive FDA response for AQST-109 epinephrine for severe allergic reaction