November 4, 2008
SANCUSO(R), the First and Only Patch for Preventing Nausea and Vomiting in Chemotherapy Patients, Now Available
BEDMINSTER, N.J., Nov. 4 /PRNewswire-FirstCall/ -- ProStrakan Group plc today announced that SANCUSO(R) (Granisetron Transdermal System) is now available by prescription for patients with chemotherapy-induced nausea and vomiting (CINV) in the United States. Sancuso was approved by the U.S. Food and Drug Administration (F.D.A.) in September 2008 as the first and only patch to provide up to five consecutive days of control of nausea and vomiting for patients receiving a moderately and/or highly nausea-inducing chemotherapy regimen.
"Chemotherapy-induced nausea and vomiting is one of the most feared side effects of chemotherapy, often times forcing patients to stop important cancer treatments," said company CEO Wilson Totten, MD. "Now, with the availability of Sancuso, healthcare practitioners, patients and caregivers have a new tool in their toolbox to prevent the debilitating side effects of CINV."Sancuso is a transdermal system, or skin patch, that delivers granisetron, its active component and an established preventor of nausea and vomiting, through a thin layer of adhesive that attaches the patch to the skin on the upper outer arm. The medicine is then released slowly and continuously into the bloodstream for up to five consecutive days.
"As a company dedicated to the needs of the patients, we are thrilled to be launching our first product in the U.S.," added Totten. "The ability to successfully bring Sancuso to the oncology community opens doors for us to introduce other supportive oncology care products, particularly those designed for easier patient use."
A Distinctive Sales Force
In order to better meet the needs of patients and oncology health-care professionals, the Sancuso sales force has been trained by oncology nurses through a partnership with ONSEdge(R), a subsidiary of the Oncology Nursing Society. Each member of the sales force participated in a detailed training program administered by oncology nurses, which focused on both general oncology and CINV.
"We believe that the best way to understand and appreciate the needs of health-care providers is to be trained by them. As a result of our collaboration with ONSEdge, our sales force is well-prepared to discuss SANCUSO in a responsible way and in a manner that will better serve the community at large," said Totten.
ProStrakan's robust 67-person sales force in the U.S. was hired in partnership with NovaQuest, the managed partnership group of Quintiles Transnational.
Additionally, as part of the company's ongoing commitment, ProStrakan has developed a patient assistance program to ensure that Sancuso is available to any qualified patients who would benefit from it. Please visit http://www.sancuso.com/ for additional information. The company is also working with regulatory authorities to bring Sancuso to market in Europe.
Chemotherapy-induced nausea and vomiting (CINV) are commonly cited by patients undergoing chemotherapy as highly feared side effects. In addition to its social and emotional effects, if left untreated, CINV can lead to dehydration, malnutrition, treatment delay, or even discontinuation of treatment. Despite advances in treatment, CINV remains a significant problem. Some patients expect to endure unpleasant symptoms in order to continue chemotherapy and may suffer at home while not under the supervision of a health-care professional. With one application of Sancuso, patients receive up to five consecutive days of CINV treatment.
Important Safety Information About SANCUSO(R)
Sancuso is contraindicated in patients with known hypersensitivity to granisetron or to any of the components of the patch.
Granisetron may mask a progressive ileus and/or gastric distention caused by the underlying condition. Mild application site reactions have occurred; remove patch if severe reactions or a generalized skin reaction occur. Patients should avoid direct exposure of application site to natural or artificial sunlight by covering with clothing while wearing the patch and for 10 days after removing it.
The most common adverse reaction is constipation. No clinically relevant drug interactions have been reported in clinical studies with Sancuso.
ProStrakan is one of Europe's fastest growing pharmaceutical companies, with new U.S. headquarters in Bedminster, New Jersey. ProStrakan is committed to developing innovative therapies to improve the lives of patients. Our current products range from cancer, women's health, men's health, anesthesiology, and cardiovascular disease. For more information on ProStrakan, please visit http://www.prostrakan-usa.com/.
ProStrakan Group plc
CONTACT: For ProStrakan U.S. - Nancie Steinberg, ChamberlainCommunications, +1-212-884-0667, [email protected]; or forProStrakan UK - Callum Spreng, Corporate Communications Director, +44 (0)1896-664000, [email protected]
Web site: http://www.prostrakan-usa.com/