UPDATE:FDA: Effectiveness Of Forest's Lung Drug 'Quite Modest'

The Food and Drug Administration said Monday that the effectiveness of a proposed new type of lung drug from Forest Laboratories Inc. (FRX) is "quite modest."

The drug, roflumilast, is designed to treat chronic obstructive pulmonary disease, or COPD, which is a group of lung conditions such as emphysema and chronic bronchitis that cause a narrowing of airways in the lungs, making it difficult to breathe. COPD is the fourth-leading cause of death in the U.S.

The product, which would be sold under the brand name Daxas, faces a review Wednesday by the FDA's pulmonary-allergy advisory committee, which is composed of non-FDA medical experts. The panel is being asked to make recommendations about whether it thinks the agency should approve Daxas. The FDA isn't required to follow the advice of its panels but usually does.

Daxas, a tablet that would be taken once daily, works by inhibiting an enzyme called phosphodiesterase 4, which is believed to play a role in the inflammatory process involved with airway constriction. It would fall into a category of drugs known as PDE-4 inhibitors.

So far, companies have struggled to develop PDE-4 inhibitor products. In 2003, an FDA panel voted against approval of a similar drug, cilomilast, which was being developed by GlaxoSmithKline PLC (GSK).

Another company, Nycomed, submitted the Daxas application to the FDA last July, but the application was transferred to Forest in December, according to the FDA. The FDA said Forest amended the application and proposed a narrower indication for the product as well as a warning regarding neuropsychiatric events.

In a review of Daxas posted to the FDA's Web site on Monday, the agency said there were more psychiatric side effects seen in clinical studies of the drug and gastrointestinal side effects such as diarrhea and nausea.

"Of significant concern are the occurrence of three completed suicides and two suicide attempts" among patients receiving Daxas compared to no suicides or attempts in the placebo group, the FDA said.

The agency said, while clinical studies looking at Daxas showed there was a statistically significant improvement in a measure of lung function compared to groups of patients not taking the drug, "the differences between the groups in mean change from baseline were quite modest."

The FDA's review of Daxas focused on eight studies. In some of the studies Daxas was added to salmetrol, sold as Serevent by GlaxoSmithKline or Spiriva, co-marketed by Boehringer Ingelheim GMBH and Pfizer Inc. (PFE), which are other drugs approved to treat COPD.

In a document prepared for Wednesday's meeting that was also posted to the FDA's Web site, Forest said Daxas "represents a significant addition to the armamentarium" of COPD treatments.

The company said studies showed that Daxas resulted in a statistically significant and clinically meaningful reduction of moderate and severe exacerbations and in an improvement of lung function in moderate as well as in severe COPD cases with chronic bronchitis.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com

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