FDA: Effectiveness Of Forest Lung Drug Daxas `Quite Modest'
April 05 2010 - 10:10AM
Dow Jones News
The Food and Drug Administration said Monday that the
effectiveness of a proposed lung drug from Forest Laboratories Inc.
(FRX) was "quite modest."
The drug, roflumilast, is designed to treat chronic obstructive
pulmonary disease, or COPD. If approved the product would be sold
under the brand name Daxas.
The product 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.
In a review of Daxas posted to FDA's Web site on Monday, the
agency also 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, FDA
said.
The agency said, while clinical studies looking at Daxas showed
there was a statistical significant improvement in lung function
compared to groups of patients not taking the drug, "the
differences between the groups in mean change from baseline were
quite modest."
Daxas, an oral 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.
Another company, Nycomed, submitted the Daxas application to FDA
last July, but the application was transferred to Forest in
December, according to FDA.
The agency said Forest proposed a narrower indication for Daxas
as well as a warning regarding neuropsychiatric events.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
jennifer.corbett@dowjones.com
Forest Road Acquisition (NYSE:FRX)
Historical Stock Chart
From May 2024 to Jun 2024
Forest Road Acquisition (NYSE:FRX)
Historical Stock Chart
From Jun 2023 to Jun 2024
