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Trospium Is Now Available in Pharmacies
Sanctura was recently approved by the U.S. Food and Drug Administration (FDA) and is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency. With an estimated 33 million Americans suffering from OAB, and a small segment of these believed to be receiving therapy, treatment with Sanctura could benefit millions of men and women seeking relief from their symptoms.
"As increasing numbers of Americans face the daily challenge of OAB, physicians are seeking additional therapeutic options," said David R. Staskin, M.D., director, section of voiding dysfunction, New York Presbyterian Hospital and associate professor of urology and obstetrics and gynecology at Weill-Cornell Medical College. "OAB often has a significant impact on the quality of patients' lives and limits many of their daily activities, yet studies have shown that the vast majority of individuals with OAB do not seek medical care and that many patients do not remain on therapy over the long term due to efficacy and tolerability issues.
"The arrival of Sanctura will help raise awareness within the physician and patient community that safe, effective and tolerable relief for the symptoms of OAB is available," said Dr. Staskin. "Sanctura represents a balance between safety and efficacy, and it offers product attributes that make it an attractive treatment option for many patients and physicians eager to address the clinical consequences of this condition."
"We are excited and proud as a company about Sanctura'S launch and its availability to millions of patients and physicians in the U.S.," said Glenn L. Cooper, M.D., chairman, president and chief executive officer of Indevus. "Our acquisition and development of Sanctura was based on recognition of market opportunity and the therapeutic need for a better balance between tolerability and efficacy in treating OAB. We are pleased to have completed the clinical development and the FDA regulatory review process for Sanctura in a timely fashion, and we believe Sanctura will occupy an important and valuable place for many years to come in the large and expanding market to treat one of the most prevalent chronic conditions in the U.S."
"This is an important day for Odyssey, as SANCTURA expands our urology franchise, as well as for the millions of Americans suffering from OAB without appropriate treatments," said Paul Cottone, president and chief executive officer of Odyssey Pharmaceuticals. "We have worked hard to get this product to consumers and are excited to see it available today in over 35,000 pharmacies across the country."
Sanctura is being launched and co-promoted to urology specialists, obstetricians, gynecologists and primary care physicians by a joint sales force of Indevus and Odyssey numbering approximately 480 sales representatives.
Sanctura is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency. The most commonly reported side effects in Phase III U.S. clinical trials were dry mouth (20.1 percent for Sanctura vs. 5.8 percent for placebo) and constipation (9.6 percent for Sanctura vs. 4.6 percent for placebo). Patients who have urinary retention, gastric retention, uncontrolled narrow-angle glaucoma or hypersensitivity to Sanctura should not use Sanctura. Complete prescribing information for Sanctura is available from the Company upon request.
Sanctura, a quaternary 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.
Sanctura has been extensively studied and is currently marketed as a prescription drug product in Europe, where it is one of the leading products for overactive bladder / urinary incontinence. Indevus licensed exclusive U.S. rights to Sanctura from Madaus AG, a German pharmaceutical company, in late 1999.
Source: Indevus Pharmaceuticals, Inc.