Somaxon buoyed by FDA word on OTC Silenor

Somaxon Pharmaceuticals sees a way forward with its sleep drug Silenor. The drug is a branded version of the long-generic antidepressant doxepin, so it's no surprise that generic rivals are already circling, a little over one year into Silenor's FDA approval. A marketing partnership with Procter & Gamble hasn't delivered a major spike in sales. The potential remedy? A conversion to over-the-counter status.

Somaxon announced today that, in a meeting with FDA and P&G, FDA laid out "a clear path forward toward an OTC version of Silenor." And according to the company, FDA didn't just indicate that Silenor could be developed into an OTC product. The agency also suggested that the sleep drug could win favorable labeling, namely some differentiation language around efficacy, safety and lack of addiction risk.

Meanwhile, Somaxon is scrambling to promote prescription Silenor while suing generics makers left and right. The company brought in a new SVP for sales and marketing, Michael Allen, to replace Jeff Raser, who's pursuing "other interests." Somaxon plans to put its contract sales reps from Publicis on the payroll. And it's wrapping up its co-promotion deal with P&G at year's end. The consumer goods giant remains in the mix on the OTC project; it has 120 days to negotiate for those rights before Somaxon starts courting other partners.

The problem remains, however, that Silenor is even more of a me-too drug than the average me-too drug. Though the company markets 3 mg and 6 mg doses of Silenor, much lower strengths than the lowest available 10 mg dose of doxepin, the fact remains that doxepin has been used as a sleep remedy for years, as Daniel Carlat points out at his blog. And Silenor competes with some well established insomnia drugs, several of which have gone off patent.

- see the release from Somaxon