BEDMINSTER, N.J., Nov. 4 ProStrakan Group plc(LSE: PSK) today announced that SANCUSO(R) (Granisetron Transdermal System) isnow available by prescription for patients with chemotherapy-induced nauseaand 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 onlypatch to provide up to five consecutive days of control of nausea and vomitingfor patients receiving a moderately and/or highly nausea-inducing chemotherapyregimen.
"Chemotherapy-induced nausea and vomiting is one of the most feared sideeffects of chemotherapy, often times forcing patients to stop important cancertreatments," said company CEO Wilson Totten, MD. "Now, with the availabilityof Sancuso, healthcare practitioners, patients and caregivers have a new toolin 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 theupper outer arm. The medicine is then released slowly and continuously intothe bloodstream for up to five consecutive days.
"As a company dedicated to the needs of the patients, we are thrilled tobe launching our first product in the U.S.," added Totten. "The ability tosuccessfully bring Sancuso to the oncology community opens doors for us tointroduce other supportive oncology care products, particularly those designedfor easier patient use."
A Distinctive Sales Force
In order to better meet the needs of patients and oncology health-careprofessionals, the Sancuso sales force has been trained by oncology nursesthrough a partnership with ONSEdge(R), a subsidiary of the Oncology NursingSociety. Each member of the sales force participated in a detailed trainingprogram administered by oncology nurses, which focused on both generaloncology and CINV.
"We believe that the best way to understand and appreciate the needs ofhealth-care providers is to be trained by them. As a result of ourcollaboration with ONSEdge, our sales force is well-prepared to discussSANCUSO in a responsible way and in a manner that will better serve thecommunity at large," said Totten.
ProStrakan's robust 67-person sales force in the U.S. was hired inpartnership with NovaQuest, the managed partnership group of QuintilesTransnational.
Additionally, as part of the company's ongoing commitment, ProStrakan hasdeveloped a patient assistance program to ensure that Sancuso is available toany qualified patients who would benefit from it. Please visitwww.Sancuso.com for additional information. The company is also working withregulatory authorities to bring Sancuso to market in Europe.
Chemotherapy-induced nausea and vomiting (CINV) are commonly cited bypatients undergoing chemotherapy as highly feared side effects. In additionto its social and emotional effects, if left untreated, CINV can lead todehydration, malnutrition, treatment delay, or even discontinuation oftreatment. Despite advances in treatment, CINV remains a significant problem.Some patients expect to endure unpleasant symptoms in order to continuechemotherapy and may suffer at home while not under the supervision of ahealth-care professional. With one application of Sancuso, patients receiveup to five consecutive days of CINV treatment.
Important Safety Information About SANCUSO(R)
Sancuso is contraindicated in patients with known hypersensitivity togranisetron or to any of the components of the patch.
Granisetron may mask a progressive ileus and/or gastric distention causedby 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 orartificial sunlight by covering with clothing while wearing the patch and for10 days after removing it.
The most common adverse reaction is constipation. No clinically relevantdrug 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 committedto developing innovative therapies to improve the lives of patients. Ourcurrent products range from cancer, women's health, men's health,anesthesiology, and cardiovascular disease. For more information onProStrakan, please visit www.ProStrakan-USA.com.
SOURCE ProStrakan Group plc