AQST - Aquestive wins FDA tentative approval for ant-seizure medication

• Aquestive Therapeutics ( NASDAQ: AQST ), a company focused on different formulations of drugs announced Wednesday that the FDA granted tentative approval for Libervant (diazepam) Buccal Film for acute treatment of seizure in epilepsy patients aged 12 years and older.
• Specifically, Libervant is indicated for intermittent, stereotypic episodes of frequent seizure activity that is different from the usual seizure pattern of epilepsy patients.
• However, the Libervant’s full FDA apporval and subsequent U.S. market launch depends on the expiration or ineligibility of the orphan drug market exclusivity granted for Valtoco a diazepam nasal spray product.
• Welcoming the FDA decision, Daniel Barber, Chief Executive Officer of AQST highlighted the market opportunity for alternative diazepam options.
• “A significant unmet need exists for additional alternate delivery options given the ongoing shortage of diazepam rectal gel, which continues to represent a substantial portion of the current diazepam rescue market,” he added.

For further details see: