Aquestive wins FDA nod for seizure oral film

Shares in Aquestive Therapeutics (NSDQ:AQST) rose today after the company announced FDA approval for its Sympazan oral film for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome.

The clobazam oral film is the first product of its kind to be approved by the FDA as a treatment for seizures associated with LGS, according to Aquestive. Clobazam has previously been available as a tablet and an oral suspension.

LGS, which begins in early childhood, is a severe form of epilepsy that’s characterized by seizures and intellectual disability. Due to physical and behavioral limitations, people with LGS often have trouble taking oral pills or large volumes of suspension.

“Aquestive Therapeutics is pleased to bring Sympazan to the LGS community,” CEO Keith Kendall said in prepared remarks. “Treating LGS can be difficult; patients may have a hard time swallowing oral medications. We’re optimistic Sympazan can help address unmet medical needs and be an important treatment option for this patient population.”

“Sympazan is the beginning of a meaningful CNS franchise for Aquestive,” Kendall added. “We are actively working to advance more redesigned, proprietary treatments that can offer meaningful improvements for patients and caregivers who live with epilepsy and other complex conditions.”

The company plans to launch Sympazan in November. AQST shares were trading at $16.89 apiece in mid-afternoon activity today, up +10.8%.

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