AQST - Aquestive Therapeutics releases positive clinical data on anaphylm for anaphylaxis treatment

2023-05-31 11:07:40 ET

• Aquestive Therapeutics released clinical data from recent pilot studies on Anaphylm, a sublingual film for the treatment of anaphylaxis.
• The studies showed that Anaphylm achieved a maximum blood concentration (Tmax) in a median time of 10 minutes, ranging from 5 to 20 minutes.
• Early drug exposure at 10 minutes (pAUC0-10min) for Anaphylm was similar to Auvi-Q auto-injector and over 4 times higher than manual injection of epinephrine 0.3mg, but lower than EpiPen auto-injector and the generic equivalent.
• Pharmacodynamic effects were observed as early as 2 minutes for both Anaphylm and the auto-injectors.
• The company successfully identified a target range for comparing Anaphylm to approved epinephrine formulations for an upcoming pivotal study.
• Aquestive plans to submit the protocol for the pivotal study to the FDA in the third quarter of 2023.
• Anaphylm demonstrated rapid absorption of epinephrine, emphasizing the importance of quick treatment for anaphylaxis.
• Anaphylm showed higher epinephrine levels than manual injections and maintained significant increases in systolic blood pressure for 1 hour.
• A pilot study compared Anaphylm with different auto-injectors and manual injection, providing data for the upcoming pivotal study.
• Repeat doses of Anaphylm were found to be effective with comparable results to the auto-injectors.
• Anaphylaxis is a serious and potentially fatal hypersensitivity reaction, affecting millions of people in the United States.
• Epinephrine injection is the current standard treatment for anaphylaxis.
• Press Release

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