FDA Approves Liquid Epilepsy Drug From Azurity After Denial

On the second attempt, Azurity Pharmaceuticals was able to secure an FDA nod for its zonisamide oral suspension, making it the first firm to do so in the United States. In February 2021, Massachusetts-based Azurity acquired the rights to the medicine, which would be marketed as Zonisade. The candidate was getting close to a PDUFA judgement date in May at the time. The FDA was unable to inspect a production facility due to travel limitations connected to the pandemic, so rather than certifying the formulation, it wrote a detailed response letter.

When the FDA investigated the factory at the root of the earlier denial, the odds of the product reaching the market increased. Azurity finally received the long-awaited permission on July 18, putting it in a position to market Zonisade as an adjuvant treatment for partial seizures in epilepsy patients 16 years of age and older.

According to IQVIA data cited by Eton, the market for other zonisamide formulations that are already available accounts for $65 million annually. M.D., of the University of Tennessee Health Science Center, Jim Wheless, sees reasons to believe Zonisade can gain market share.

In a statement, Wheless stated that the provider community continues to pursue dependable formulations of medications that may ease the burden on epilepsy patients and caregivers and help enhance treatment adherence. In patients who have trouble ingesting or who are incapable or reluctant to accept tablets, Zonisade serves a critical unmet need.

With this permission, Azurity may now legally market two of the three medications it obtained when it bought the neurology portfolio from Eton. The topiramate oral solution was approved by the FDA in November 2021. However, the lamotrigine contender received a comprehensive response letter from the FDA in May 2022. When Zonisade debuts, Eton is eligible for a $5 million reward.