Forest Laboratories and Spain's Almirall say that a planned NDA filing for their new COPD drug will be delayed for an uncertain amount of time after the FDA made it clear that the developers will need to conduct additional studies on aclidinium bromide. The drug has been considered a potential competitor to Boehringer Ingelheim's blockbuster Spiriva.

The drug developers had planned on filing an NDA later this year or in early 2010 but they now say they don't know exactly when they will be able to push for marketing approval. The new studies will involve higher doses delivered more frequently.

Analysts have been fretting over this drug since last fall, after two late-stage studies failed to make a clearly convincing case for the therapy. One study involving more than 1,600 patients did not reach a statistically significant point at week 52 but did hit that goal at all previous time points. Almirall's director of medical and regulatory affairs told PharmaTimes last October that the developers were discussing a new trial to determine optimal dosing.

- read the release [1]
- check out the report [2] from Dow Jones
- here's the story [3] from PharmaTimes

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