Azurity Gets FDA Nod for Zonisade in Patients With Epilepsy

The FDA has approved Azurity Pharmaceuticals’ Zonisade (zonisamide oral suspension) as an adjunctive therapy for the treatment of partial seizures in epilepsy patients aged 16 years and older.

The approval makes Zonisade the only FDA-approved oral liquid formulation of zonisamide. The oral formulation will benefit patients who have difficulty swallowing or who are unable or unwilling to take tablets, the company said.

The drug’s efficacy and tolerability were established in three clinical trials, but not for individuals under 16 years old.

In a Complete Response Letter to Azurity in 2021, the FDA declined to approve the company’s New Drug Application because the agency was unable to inspect a third-party manufacturing facility due to travel restrictions.