Cypress Fibromyalgia Drug Stalled by FDA

10/20/08Follow @xconomy

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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  • http://www.pnf.org Frank Cook

    I am writing to you from the Pacific Northwest Foundation about a case study that may be of interest to your concerns regarding fibromyalgia. While this was not a study undertaken by the Foundation, it was a case with which we have had access to in virtually every detail. This includes the chart notes (with the patient’s approval) as well as the observations and insights of the patient’s health care provider.

    The case involves an adult female who had been disabled for eight years with diagnosed fibromyalgia. Within four months of treatment, she was able to backpack, regularly work a full day and have little or no pain.

    As with all our studies, it is our hope to stimulate additional efforts to determine if these results were an aberration or have wider implications. To this end, we wanted to make you aware of the cast study (which can be found online at http://pnf.org/html/fibromyalgia.html), in the hope that it might prove useful as a starting point for research within your organization.

    Thanks and kind regards,

    Frank Cook
    Pacific Northwest Foundation

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