U.S. FDA declines to approve Eton Pharma’s anti-seizure drug

(Reuters) – Eton Prescribed drugs Inc stated on Friday the U.S. Meals and Drug Administration declined to approve its anti-seizure drug lamotrigine, sending the drugmaker’s shares down 13% in prolonged buying and selling.

Eton was notified that its privately held companion Azurity Prescribed drugs obtained an entire response letter from the well being regulator for lamotrigine, it stated in a regulatory submitting.

Lamotrigine was one of many three medication in Eton’s neurology portfolio that the drugmaker bought to Azurity Prescribed drugs final yr for as much as $45 million in milestone funds.

The drug is a liquid type of a extensively accessible anticonvulsant or antiepileptic oral pill, which additionally goes by the title lamotrigine. It helps stabilize electrical exercise contained in the mind and makes it more durable for sure neurons to get stimulated, thus stopping seizures.

The drugmaker didn’t disclose the main points of the whole response letter and added that it was assessing the FDA’s feedback together with its companion.

Eton and Azurity didn’t instantly reply to Reuters’ requests for extra particulars on the whole response letter.

In 2020, the FDA declined to approve the usage of the drug, citing the necessity for a further research to point out that sufferers can put together and administer the oral suspension safely and successfully.

The drugmaker’s companion submitted outcomes from the extra research to the FDA within the fourth quarter of 2021.

(Reporting by Bhanvi Satija and Mrinalika Roy in Bengaluru; Modifying by Amy Caren Daniel)