FDA declines to approve Dainippon's epilepsy drug

Last fall, when Dainippon Sumitomo Pharma announced that it had inked a deal to buy Sepracor for $2.6 billion, the Japanese pharma company cited the once-daily epilepsy drug Stedesa as one of the near-term drug prospects it was most excited about. Yesterday afternoon, though, the FDA declined to approve Stedesa, and now Dainippon is attempting to sort out what steps it will have to take next.

Dainippon didn't spell out exactly what the FDA discussed in its complete response letter. And a spokesperson didn't add much when contacted by Bloomberg.

"Sepracor will meet with the FDA to discuss and better understand the complete response letter and the agency's expectations," wrote spokesperson Susan Adler in an e-mail. "This will include whether there is a need to conduct any new studies on Stedesa."

"While we are disappointed by this decision, we are committed to working closely with the FDA to gain approval of Stedesa, which we continue to believe has significant potential to address the continuing unmet need in the treatment of patients with epilepsy," says Saburo Hamanaka, the CEO of the Marlborough, MA-based Sepracor, in a statement. Stedesa was studied in three Phase III trials which involved more than 1,000 patients from 23 countries.

- here's Sepracor's press release
- and here's the piece from Bloomberg