The European Medicines Agency (EMA) has granted approval for ProStrakan Group plc to market SANCUSO® (Granisetron Transdermal System) in the European Union (EU), with 3M Drug Delivery Systems acting as the manufacturer. ProStrakan begins marketing the product this month in the United Kingdom, Germany and the Netherlands. Additional European countries are expected to be added in 2014.
Initially introduced in the United States in 2008, SANCUSO is the first and only treatment for chemotherapy-induced nausea and vomiting that does not require pills or intravenous (IV) administration. The transdermal patch is applied to the upper arm and can be worn for seven days, providing continuous transdermal delivery and eliminating the need to take pills daily to control nausea and vomiting. This simple-to-use treatment has been proven effective in patients at risk for chemotherapy-induced nausea and vomiting.
“SANCUSO is a great illustration of the patient-friendly benefits of transdermal treatment,” said Jim Ingebrand, president and general manager, 3M Drug Delivery Systems. “We look forward to a continued partnership with ProStrakan to bring SANCUSO to new markets.”
3M Drug Delivery Systems is applying more than 30 years of transdermal experience and regulatory expertise to its manufacturing responsibilities for SANCUSO. The company’s cGMP compliant manufacturing and strength in global supply chain management ensure reliability and a smooth process from start to finish for manufacturing partners.“SANCUSO is already proving to be an important option for patients in the U.S. suffering from chemotherapy-induced nausea and vomiting,” said Jamie Blackport, senior vice president of international marketing at ProStrakan. “We are excited about working together with 3M to bring this important treatment to patients in the EU.” While ProStrakan has previously relied on a different manufacturer for the U.S. supply of SANCUSO, FDA approval is currently pending for the 3M Drug Delivery Systems manufactured product.