Cypress Bioscience will have to wait a while longer before it can start marketing its first drug. The San Diego company (NASDAQ: CYPB) and its partner, New York-based Forest Laboratories, said today the FDA wasn’t able to make a final decision by its Oct. 18 deadline on whether to clear milnacipran—already approved outside of the U.S. for depression—for sale as a new drug for fibromyalgia in the United States.
The FDA hasn’t requested any new information from the companies, but did ask the companies to confirm a question it had about some clinical trial data on the treatment. The FDA has been missing some of its deadlines lately, like with Amgen’s romiplostim (Nplate) for a bleeding disorder, so it’s not exactly a shock that the agency stalled this application. The companies said they continue to plan to start selling the drug in the first quarter of 2009.
As we discussed in a profile a couple weeks ago, Cypress sees this as a big opportunity to sell a drug for a pain condition that patient advocates say affects as many as 6 million people in the U.S., with about 90 percent of them being women. Pfizer’s pregabalin (Lyrica) and Eli Lilly’s duloxetine (Cymbalta) are the first drugs approved specifically for this condition. It sounds like the companies remain confident they can answer the FDA’s question about their application, but Cypress will likely have to remain in limbo for at least a few more weeks while the FDA digs through the piles of applications stacking up on its desk.
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