Analysts are raising the prospect that new FDA questions concerning Neurocrine's lead drug candidate--the sleep drug indiplon--may force the company to choose between launching expensive new trials or abandoning the drug. The agency's concerns have centered on Neurocrine's request to approve a 15 milligram dose of the drug when the majority of its data is based on the results from higher doses. The FDA has already issued a non-approvable letter for the higher doses, which caused Neurocrine's stock to plunge. The agency has issued approvable letters for five and 10 mg doses, but analysts say the drug's chances at achieving blockbuster status revolve around the 15 mg dose. Lower doses induce sleep but do not maintain it. Pfizer is Neurocrine's marketing partner on indiplon. Executives at the San Diego-based company are seeking a meeting with the FDA to further explore its concerns.
- here's the article on indiplon from the San Diego Union-Tribune