BioDelivery Sciences International (BDSI), a drug delivery technology company in Raleigh, North Carolina, said today its drug BREAKYL received approval for marketing by the German review authorities. Meda, a Swedish pharmaceutical company, partnered with BDSI on the development of the drug.
The approval of BREAKYL by Germany will apply to all Europe Commission countries, since the review follows the Decentralized Procedure of the European Medicines Evaluation Agency. This procedure provides for mutual recognition of licenses granted by existing control authorities in other EC countries, and Germany in this case served as the Reference Member State.
The drug, marketed as Onsolis and BEMA Fentanyl in North America, is an opioid analgesic prescribed only for the management of intense pain in adult patients with cancer. Onsolis/BEMA Fentanyl uses BDSI’s BioErodible MucoAdhesive (BEMA) delivery technology consisting of a small, erodible polymer film for application to the mucosal membranes on the inner lining of the patient’s cheek.
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