FDA Approves Sancuso Patch

ProStrakan Group received approval from the FDA for Sancuso (Granisetron Transdermal System), the first patch to provide five days of control of nausea and vomiting for patients undergoing chemotherapy.
   
Chemotherapy-induced nausea and vomiting (CINV) is common among patients undergoing chemotherapy and can lead to dehydration, malnutrition, treatment delay, or even discontinuation of treatment.
   
Sancuso is a transdermal patch that delivers granisetron through a thin layer of adhesive that attaches to the skin. The medicine is then released slowly and continuously into the bloodstream for as many as five consecutive days.
   
The approval is based on the results from a multicenter Phase III randomized, double-blind, study comparing the efficacy, tolerability and safety of Sancuso with once-daily oral granisetron. The trial enrolled 641 patients undergoing 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 and/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.