The joint venture, Angelini Labopharm, is expected to launch Oleptro, Labopharm’s novel once-daily formulation of trazodone indicated for the treatment of major depressive disorder in adults, in the US in the third quarter of this year.
Earlier, both the entities have entered into an agreement to establish a joint venture in the US for the commercialisation of Oleptro.
Labopharm had received FDA approval for Oleptro (trazodone hydrochloride) extended release tablets on Feb 3, 2010. Oleptro utilises Contramid, Labopharm’s clinically validated technology that controls the release of active substances within oral medications.
Contramid, in its dry state, acts as a free-flowing, highly compressible powder. When in tablet form and wetted, it forms a long-lasting, uniform surface membrane that is ideally suited to controlled release of orally administered drugs under a broad range of in-body conditions, said Labopharm..
An eight-week randomised, double-blind, two-arm, multi-centre study in patients with unipolar major depressive disorder demonstrated Oleptro’s efficacy as a treatment for depression. Labopharm said that in the trial, statistical significance was achieved for the primary endpoint.