September 16, 2008
ProStrakan Wins FDA Approval for Nausea Control Patch
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."