Shares of Labopharm, Inc.(NASDAQ: DDSS) surged 50 percent in trading Wednesday after the company announced that the manufacturer of the active ingredient in Labopharm’s novel anti-depression medication had been given the green light from the US Food and Drug Administration (FDA) to reopen its manufacturing facility, which had been closed following FDA inspection in June and July of this year.
In a letter received by Labopharm, the FDA states that Angelini, the manufacturer of the active pharmaceutical ingredient (API) for Labopharm’s novel trazodone formulation, has sufficiently addressed all the deficiencies cited during inspections in June and July. The letter also states that the FDA now classifies the manufacturing facility as acceptable.
The letter received today from the FDA comes after another received by the Company on July 17, 2009, in which the FDA informed the Labopharma that it’s new drug application for its novel trazodone formulation could not be approved in its present form due to the deficiencies at the API supplier’s manufacturing facility, although it was stated that the deficiencies were not efficacy or safety issues.
Trazodone, Labopharma’s second product, is a psychoactive compound with anti-depressant and sedative properties that also encompasses the Company’s proprietary controlled-release technologies. Trazodone is currently awaiting FDA approval.
Labopharm Inc. is an emerging biopharmaceutical company that specializes in improving and optimizing existing small-capsule drugs using proprietary time-release technologies. The Company’s first product, a once-daily time-release treatment for chronic pain is sold in 17 countries worldwide in major markets such as US, Canada, and Europe.