Sancuso(R) Clinical Trial Application Filed In China

Main Category: Cancer / Oncology
Also Included In: Clinical Trials / Drug Trials
Article Date: 02 Jun 2009 - 8:00 PDT

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Solasia Pharma K.K., a developer of Western oncology pharmaceuticals in-licensed for commercialization in Asian markets, announced today the filing of clinical trial application (CTA) of SP-01 (long-acting transdermal granisetron patch; brand name: Sancuso®) to the China State Food and Drug Administration (SFDA). This represents the first regulatory-related filing in China made by Solasia. Upon SFDA approval of the application expected in the 1st quarter of 2010, Solasia will initiate Sancuso clinical trials in China through Excel PharmaStudies Inc. (http://www.excel-china.com), China's largest Clinical Research Organization (CRO).

Sancuso is the first and only commercialized long-acting granisetron transdermal product. By releasing the anti-emetic agent granisetron over a 5-day period, Sancuso reduces the need for daily dosing of injectable and oral agents. In China, Sancuso is expected to be well accepted by physicians and nurses seeking a more convenient method to prevent the debilitating effects of nausea and vomiting in patients receiving chemotherapy. As a single application provides protection over 5 days, Sancuso is expected to help reduce the duration of hospital stays of cancer patients currently receiving short-acting anti-emetic agents.

About Sancuso

Sancuso is a long-acting transdermal system, delivering the anti-emetic, granisetron, steadily into the patient's bloodstream over seven days without the need for injections or swallowing pills. Granisetron is a 5-HT3 receptor antagonist with well-established efficacy against chemotherapy-induced nausea and vomiting (CINV). Sancuso was approved by the U.S. Food & Drug Administration (FDA) on September 12, 2008. Prostrakan launched Sancuso in the U.S. in the fourth quarter of 2008. Patents protecting Sancuso have been granted in the EU (2007) and Japan (2008).

Source
Solasia Pharma K.K.