An FDA advisory panel does not recommend approval for Nycomed A/S and Forest Laboratories Inc. experimental drug Daxas (Roflumilast) indicated to treat chronic obstructive pulmonary disease (COPD).

The FDA expert panel voted 10 to 5 against Daxas approval, they argued Forest Laboratories had not provided substantial evidence to support effectiveness to reduce chronic obstructive pulmonary disease (COPD). In a previous vote experts had assured the drug was effective 9 to 6.

In fact, some of the panelists said that Daxas benefits were scarce and the product did not have side effects.

The oral pill is key for Forest´s future, as its lead selling drug, Lexapro will conclude its patent by 2012.

Before the meeting, the FDA had warned Forest Labs. About the eventual label of the product as well as concern on alleged severe neuropsychiatric problems detected during trial

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