Indevus Pharmaceuticals Inc announced that the US FDA has approved Sanctura (trospium chloride tablets). Sanctura is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency.

Under the co-promotion and licensing agreement between Indevus and Pliva announced on April 7, 2004, Sanctura will be co-promoted by a joint sales force of Indevus and Pliva through its specialty branded subsidiary, Odyssey Pharmaceuticals, Inc., to primary care physicians, urology specialists, obstetricians and gynecologists. The product launch of Sanctura is anticipated to take place during the third calendar quarter of 2004.

Sanctura, a quarternary ammonium compound, belongs to a class of anticholinergic compounds known as muscarinic receptor antagonists. These compounds relax smooth muscle tissue found in the bladder, thus decreasing bladder contractions. Overactive or unstable detrusor muscle function is believed to be the cause of overactive bladder.

"The growing numbers of people affected by overactive bladder, as well as their physicians, will benefit from the introduction of Sanctura," said David R. Staskin, director, section of voiding dysfunction, New York Presbyterian Hospital and associate professor of urology and obstetrics and gynecology at Weill-Cornell Medical College. " Sanctura offers physicians a new treatment option that has been shown to be safe and effective in patients with this debilitating condition."

"The US FDA approval of Sanctura represents the culmination of a timely and efficient clinical development and regulatory review process," said Glenn L. Cooper, chairman, president and chief executive officer of Indevus. "During the months to come, we look forward to introducing Sanctura with our partner, Odyssey, which is focusing its resources, commitment and expertise in urology on the commercialization of this product.

"Sanctura will be launched at a time of increasing awareness among the public and the medical community of the prevalence and consequences of overactive bladder," said Dr. Cooper. "Additionally, the medical community has developed a greater understanding of the etiology of the condition and how it can be treated."