- The FDA has notified Aquestive Therapeutics Inc (NASDAQ:AQST) that the agency is still considering the regulatory issues related to the approvability of Libervant and will not be ready to take action by December 23, 2021.
- The agency did note that no additional information is needed. It also said that it is currently unable to estimate the timing of an expected action.
- Libervant is a buccally (inside of the cheek) administered soluble film formulation of diazepam, a benzodiazepine intended for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity in patients with epilepsy 12 years of age and older.
- Related content: Benzinga's Full FDA Calendar.
- The Company continues to advance AQST-109 as it began the EPIPHAST study for allergic reactions. The results are expected to be available in 1H of 2022.
- AQST-109 is a polymer matrix-based film that can be applied sublingually (under the tongue) for the rapid delivery of epinephrine. The product is similar to a postage stamp and begins to dissolve on contact.
- No water or swallowing is required for administration.
- Price Action: AQST shares are down 32.5% at $4.20 during the premarket session on the last check Tuesday.
