After rejection, Azurity gets FDA nod for liquid epilepsy drug

Azurity Pharmaceuticals has won FDA approval for its zonisamide oral suspension at the second time of asking, becoming the first company to secure authorization of a liquid form of the epilepsy drug in the U.S.

Massachusetts-based Azurity picked up the rights for the product, which will be sold as Zonisade, from Eton Pharmaceuticals in February 2021. At that time, the candidate was closing in on a PDUFA decision date in May. However, rather than approving the formulation, the FDA issued a complete response letter, because pandemic-related travel restrictions stopped it from inspecting a manufacturing site.

The chances of the product coming to market improved in January, when the FDA inspected the facility at the heart of the earlier rejection. Monday, Azurity secured the long-awaited approval, positioning it to sell Zonisade as an adjunctive therapy for partial seizures in epilepsy patients aged 16 and up.

Other formulations of zonisamide are already on the market and, according to IQVIA data quoted by Eton, make up a $65 million annual market. The University of Tennessee Health Science Center’s Jim Wheless, M.D., sees reasons to think Zonisade can muscle in on the market. 

“The provider community continues to seek reliable formulations of medicines that may reduce the epilepsy patient and caregiver burden and help improve treatment adherence,” Wheless said in a statement. “Zonisade addresses an important unmet need in patients who have difficulty swallowing or who are unable or unwilling to take tablets.”

The approval means Azurity now has authorization to sell two of the three drugs it acquired when it bought Eton’s neurology portfolio. The FDA approved a topiramate oral solution in November 2021 but issued a complete response letter in relation to the lamotrigine candidate in May 2022. Eton is entitled to receive a $5 million payment when Zonisade launches.