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.”

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.