Pharmaprojects R&D Pipeline News Feed
US Approval for ProStrakan's Sancuso
22nd September 2008
ProStrakan has received US approval for its transdermal 5HT3 antagonist, Sancuso (granisetron), for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately/highly emetogenic chemotherapy for up to 5 consecutive days. Administered to the outside of the upper arm as a 3.1mg patch, Sancuso offers chemotherapy patients a non-invasive alternative to oral or injectable anti-emetics.
The US approval is based on the results of a randomized, double-blind Phase III trial in 641 patients receiving emetogenic, multi-day chemotherapy. A single dose of Sancuso showed efficacy comparable to daily doses of oral granisetron in preventing CINV, with complete control achieved in 59.8% of patients. It was safe and well tolerated, and showed no evidence of sensitisation or irritation.
ProStrakan’s CEO Dr Wilson Totten said the US approval of Sancuso marked "a very significant breakthrough, both for patients and ProStrakan".
Sancuso now becomes the world's first transdermal 5HT3 antagonist, and joins other 5HT3 antagonists such as Easi's Aloxi (palonosetron), as well as Merck's NK1 antagonist Emend (aprepitant) in the US$1.3 billion anti-emetic market. US launch is planned by the end of 2008.
