Headquartered in Laval, Quebec, Canada, Labopharm Inc. is optimizing the performance of existing small molecule drugs using their proprietary controlled-release technologies. The Company’s lead product is being commercially launched in key markets globally. This product is a unique once-daily formulation of tramadol. Their second product, a novel formulation of trazodone for the treatment of major depressive disorder, is under regulatory review by the FDA.
The Company also has a pipeline of follow-on products in both pre-clinical and clinical development. Their corporate mission is to become an integrated, international, specialty pharmaceutical company with the capability to internally develop and commercialize their own products.
Labopharm has developed a novel once-daily formulation of 150 mg and 300 mg of trazodone hydrochloride. This is a serotonin-antagonist reuptake inhibitor (SARI) for the treatment of major depressive disorder (MDD). This formulation is to address the needs of patients suffering depression to provide them an effective and convenient treatment option. In a Phase III placebo controlled study of patients with MDD, Labopharm’s trazodone formulation demonstrated antidepressant efficacy. This included rapid onset of therapeutic response, improved overall quality of sleep, a well-tolerated adverse event profile, and a very low rate of sexual dysfunction. It also included no weight gain compared to placebo. MDD is one of the most prevalent central nervous system disorders, affecting more than 120 million people worldwide.
Labopharm Inc. announced in November of 2008 that their New Drug Application (NDA) for their formulation of trazodone (DDS-04A) was accepted for review, and filed by the U.S. Food and Drug Administration (FDA). The action date under the Prescription Drug User Fee Act (PDUFA) is July 18, 2009. Labopharm based their NDA for this trazodone formulation on data from five pharmacokinetic studies and the positive results from their North American Phase III placebo controlled clinical trial (study 04ACL3-001), which enrolled more than 400 patients. The Agency advised Labopharm that one positive Phase III study is required for the formulation to be approved.
On December 31, 2008 Labopharm Inc. announced that RYZOLTâ„¢ (tramadol HCl extended release tablets) received approval by the U.S. Food and Drug Administration (FDA). RYZOLT has indications for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time. RYZOLTâ„¢ is Labopharm’s once-daily formulation of the analgesic tramadol.
James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. said, “The approval of our first product in the United States is a major milestone for our Company and we look forward to our product’s launch in the world’s largest market for pain medications.”