Valeant files IND for Cesamet with FDA

California, USA-based Valeant Pharmaceuticals International has filed an Investigational New Drug application with the Food and Drug Administration for Cesamet (nabilone) oral capsules for the treatment of cancer chemotherapy-induced neuropathic pain. Cesamet, a synthetic cannabinoid, was launched by Valeant in the USA in 2006 for the treatment of nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional anti-emetics. The drug was recently approved in Mexico for the treatment of chemotherapy-induced nausea and vomiting and pain.

"The filing of our IND is a significant milestone in the development of Cesamet. There are more than 150,000 new cases of chemotherapy-induced neuropathic pain per year in the USA, with no current approved therapy for these patients. The development of a new agent to control chemotherapy-induced neuropathic pain would fulfil a significant unmet need for patients and physicians to treat the symptoms from chemotherapy-induced neuropathic pain," said Wes Wheeler, president, Valeant North America/R&D.