Angelini Labopharm launch of Oleptro in USA for major depressive disorder in adults

Angelini Labopharm announced yesterday that its antidepressant Oleptro (trazodone hydrochloride extended-release tablets), a novel once-daily formulation, is now commercially available in the USA, where the antidepressant market is valued at over $11 billion a year. The drug, which was approved by the Food and Drug Administration in February, is indicated for the treatment of major depressive disorder (MDD) in adults.

Angelini Labopharm is a 50/50 joint venture set up earlier this year by Canada's Labopharm and Italian drugmaker Angelini, specifically to market Oleptro (which uses Labopharm's Contramid technology platform) in the USA (The Pharma Letter May 4). Under the accord, each company contributed $14 million as initial working capital for the JV.

MDD is a common mental illness often characterized by a combination of emotional, somatic, and behavioral symptoms. It affects more than 14 million adults in the US and is the leading cause of disability globally. However, the company notes, nearly 28% of patients being treated with antidepressants stop taking their medication within the first four weeks of treatment and as many as 44% stop within the first 12 weeks, due to reasons such as lack of efficacy, exacerbation of symptoms, including sleep disturbance and agitation, and/or adverse events such as weight gain or sexual dysfunction.