ProStrakan Wins FDA Approval for Nausea Control Patch
Posted on: Tuesday, 16 September 2008, 09:00 CDT
ProStrakan Group has received the FDA approval for Sancuso, which is reported to be the first and only patch to provide up to five consecutive days of control of nausea and vomiting for patients receiving a moderately or highly nausea-inducing chemotherapy regimen.
According to the company, Sancuso is a transdermal system, or skin patch, that delivers granisetron, its active component and an established inhibitor of nausea and vomiting, through a thin layer of adhesive that attaches the patch to the skin. The medicine is then released slowly and continuously into the bloodstream for up to five consecutive days.
The FDA approved Sancuso for the prevention of chemotherapy-induced nausea and vomiting (CINV) based on the results of a multicenter Phase III randomized, double-blind, double-dummy controlled study comparing the efficacy, tolerability and safety of Sancuso with once-daily oral granisetron (2mg). The trial enrolled 641 patients who received moderately or highly nausea-inducing multi-day chemotherapy, and met its primary endpoint of achieving complete control of CINV, working as well as oral granisetron.
Complete control was defined as no vomiting or retching, no more than mild nausea and no rescue medication from first administration of Sancuso until 24 hours after the last day of chemotherapy. Sancuso was generally well-tolerated by patients in clinical trials.
ProStrakan said that the FDA's approval of Sancuso marks the official introduction of the company in the US. The company is also working with regulatory authorities to bring Sancuso to market in Europe.
Wilson Totten, CEO of ProStrakan, said: "We believe that Sancuso, used within an individualized approach to therapy, can help lift the burden that CINV can have on both patients and healthcare providers."
Source: Datamonitor
Related Articles
- Stopping Nausea and Vomiting for Chemo Patients
- SANCUSO(R), the First and Only Patch for Preventing Nausea and Vomiting in Chemotherapy Patients, Now Available
- FDA Approves Aloxi Injection for Nausea and Vomiting
- FDA Approves EMEND(R) (Fosaprepitant Dimeglumine) for Injection, Merck's New Intravenous Therapy, for Use in Combination With Other Antiemetics for Prevention of Nausea and Vomiting Caused By Chemotherapy
- FDA Approves EMEND(R) (Aprepitant), Merck's Antiemetic Therapy, for the Prevention of Postoperative Nausea and Vomiting; First New Class of Postoperative Nausea and Vomiting Therapy in More Than 10 Years
- Ginger prevents postop nausea and vomiting
- Aranesp Dosed Every Three Weeks Achieved and Maintained Target Hemoglobin Levels in Patients With Chemotherapy-Induced Anemia
- New Study Shows MARINOL(R)Helps to Reduce Delayed Chemotherapy-Induced Nausea and Vomiting (CINV)
- Study of Breast Cancer Patients Showed Regimen Including EMEND-R- -Aprepitant- Prevented Nausea and Vomiting After Chemotherapy in More Patients Than a Standard Regimen
- Granisetron and Ondansetron for Prevention of Nausea and Vomiting in Patients Undergoing Modified Radical Mastectomy
 |
 |
User Comments (0)
RSS Feeds