Labopharm expects Oleptro to be available for prescription in the US later this year, with specific timing for its launch to be determined within the context of the final commercialisation plan. The company believes it is well advanced in its preparations for the US launch of Oleptro.
The company said that it has completed market research with physicians and third-party payors, developed a positioning and marketing campaign for Oleptro, and finalised product manufacturing and packaging arrangements.
Labopharm is actively exploring several alternatives for the US commercialisation of Oleptro. Such alternatives range from out-licensing the product to a distribution partner, while retaining the right to some degree of co-promotion through to a full co-promotion arrangement under which Labopharm would share the sales function with a partner. The company currently expects to finalise the commercialisation plan for Oleptro in the near term.
James Howard-Tripp, president and CEO of Labopharm, said: “Oleptro represents Labopharm’s second Contramid technology-based product to receive FDA approval in just over a year. We are excited about the opportunity for Oleptro and are preparing the product for launch into the $11bn-plus US antidepressant market. We are working towards finalising a commercialisation path for Oleptro that will maximise the value of our product in this market.”
David Sheehan, professor of University Health and Director of Depression and Anxiety Disorders Research Institute at the University of South Florida College of Medicine, said: “Our research in the clinical study leading up to FDA approval showed that Oleptro was well-tolerated and demonstrated a significantly greater improvement in the HAMD-17 primary efficacy end point over placebo. When given at the recommended daily dose range, Oleptro was an appropriate monotherapy for patients with MDD.”
Labopharm is expected to conduct a post-approval pediatric study. The FDA has asked Labopharm to provide data from a long-term maintenance study and an additional in-vitro alcohol dissolution study.