Slammed by FDA rejection, Aquestive vows to refile by end of year
Aquestive Therapeutics is still reeling from a precipitous drop in its stock price after the FDA rejected its oral film for seizure control.
Libervant, a buccal film formulation of the generic drug diazepam, would have been the biotech’s second commercial treatment for epilepsy following Sympazan (clobazam), which is approved specifically for Lennox-Gastaut syndrome.
According to a release out Friday, regulators are mainly worried about pharmacokinetics, citing in the complete response letter a study where “certain weight groups showed a lower drug exposure level than desired.”
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