Previous to the The Food and Drug Administration advisory panel meeting, the regulators office stated that Nycomed A/S drug, Daxas (roflumilast) to treat patients with chronic obstructive pulmonary disease (COPD) offers a slight improvement in lung function, but commented upon the psychiatric severe side effects associated with the drug.

Specifically, regulators officials remarked that during clinical trials, three suicides and two attempted suicides among patients given Daxas, compared to none with the placebo group.

On the other hand, FDA experts were harsh on Nycomed´s U.S. partner, Forest Laboratories Inc. to narrow the proposed use of Daxas from a broad treatment for COPD to reducing exacerbations of the disease. The agency believes Forest´s decision could be understood as a bypass of the drug´s real efficacy.

Forest offered the agency, to include a label prospect warning on neuropsychiatric problems associated with the drug´s consumption.

Daxas is an oral product, that belongs to a family of drugs known as PDE4 inhibitors, linked to inflammation.

Lazard Capital Markets analyst, Bill Tanner, asses the drug´s annual revenue, if approved, in almost 500 million dollars.