Odyssey Plans to Initiate Phase IV Study of Sanctura
Odyssey Pharmaceuticals and Indevus Pharmaceuticals have announced that Odyssey plans to initiate this month a Phase IV study of the effectiveness and safety of Sanctura in patients with overactive bladder (OAB) symptoms.
Following FDA approval of Sanctura (trospium chloride) in May 2004 for the treatment of OAB, the product has been launched and is being well-received by urologists in the U.S.
Odyssey's SECURE (Sanctura Study to Evaluate Control of Urinary Symptoms Resulting From Overactive Bladder) trial will be the largest OAB study ever conducted, enrolling roughly 4,000 patients. It will be a multicenter, prospective study conducted in the U.S.