The FDA Can't See the Forest or the Trees

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It's been over a month since Forest Laboratories (NYSE: FRX) and Cypress Bioscience (Nasdaq: CYPB) said that the Food and Drug Administration was indefinitely delaying its decision about whether to approve their fibromyalgia treatment, milnacipran.

The companies certainly wish the FDA would do something, but they're not sitting on their hands, waiting demurely. In true in-your-face fashion, Forest and Cypress released data from a third phase 3 trial, which confirmed the results of the two trials that the FDA is currently reviewing. Of course the companies were nice about it -- no need to piss off the FDA reviewers -- but I can only imagine that the executives were smiling as they issued the press release.

The companies didn't offer much data from the trial -- they're likely saving it for a scientific meeting. Hopefully the FDA won't need it, either; a request for the data could further delay the approval process, which is already nearly two months beyond the PDUFA date.

Forest and Cypress must be annoyed, but they've got company -- Eli Lilly's (NYSE: LLY) prasugrel is currently suffering a delay and CV Therapeutics' (Nasdaq: CVTX) Ranexa recently had to endure a wait. The indefinite delay -- as opposed to the more standard three-month kind -- makes launching milnacipran difficult, to say the least. The drug will enter the market against established players like Eli Lilly's Cymbalta and Pfizer's (NYSE: PFE) Lyrica. How can the companies hit the ground running if they don't know when an approval might be handed down?

I think we're likely to see an eventual approval. Hopefully this latest release of data reminds the FDA that it's got an application gathering dust. I'll join in the company's call: Approve the thing already.

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