Labopharm Inc. (DDSS) has received U.S. Food and Drug Administration approval for its once-daily formulation of the antidepressant trazodone for adults.
The FDA had been expected to make an approval decision by Feb. 11.
Labopharm's OLEPTRO Extended Release Tablets have been approved for the treatment of major depressive disorder in adults.
The Canadian specialty-pharma company said it's actively exploring several alternatives for the U.S. commercialization of OLEPTRO and expects the drug to be available for prescription in the U.S. later this year.
Labopharm said it will conduct a post-approval pediatric study. The FDA has asked it to provide data from a long-term maintenance study and an additional in-vitro alcohol dissolution study.
On Nasdaq Tuesday, Labopharm closed at $2.61, down 1.9%. In pre-market trading Wednesday, it's up about 15%.
-By Judy McKinnon, Dow Jones Newswires; 416-306-2100; firstname.lastname@example.org