The US FDA has declined to approve the anti-seizure drug, lamotrigine, by Eton Pharmaceuticals Inc. Lamotrigine was one of the three drugs in Eton’s neurology portfolio that the drugmaker sold to Azurity Pharmaceuticals last year for up to $45 million in milestone payments. 

The drug is available as a liquid form of an anticonvulsant or an antiepileptic oral tablet. It is used in stabilizing electrical activity inside the brain, making it difficult for some neurons to get activated, thereby preventing seizures. 

Earlier in 2020, the FDA had declined the approval of the drug, asking for an additional study to demonstrate that patients can safely and effectively prepare and self-administer the oral suspension. This time, the drugmaker has not disclosed the details of the response letter from the FDA and is working with partner Azurity to assess the FDA’s comments. 

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