Firm claims transmucosal product already has 24% share of fast-acting fentanyl market in major EU markets.

ProStrakan was granted FDA clearance for the sublingual fentanyl drug Abstral® as a treatment for breakthrough cancer pain in adults already receiving opioid analgesics. As part of the approval the firm has agreed to conduct a post-approval study with the drug in children.

ProStrakan has developed Abstral for the EU and U.S. markets through its collaboration with Orexo. Launch in major EU markets was achieved in 2009, and sales of the drug reached £14.1 million (about $22.1 million) in the first 10 months of 2010. ProStrakan says estimates suggest the drug now has a 24% share of the fast-acting fentanyl market in primary European territories.

The firm claims FDA clearance represents the first in the U.S. for an immediate-release sublingual tablet for breakthrough cancer pain. It says the U.S. market for fast-acting fentanyl products is estimated to be worth about $550 million annually. Under terms of the Abstral development and commercialization deal between ProStrakan and Orexo, the latter will receive 23-28% royalties on net sales in the U.S., on top of its 25-30% royalties on net sales in Europe.

Abstral is also the first product to be approved in the U.S. with the FDA mandated class Risk Evalaution and Mitigation Strategy (REMS) for transmucosal immediate-release fentanyl products. The REMS program will enable Abstral to be dispensed at enrolled retail pharmacies across the U.S., as well as by the hospital system.  “When fully implemented, FDA expects that prescribers, pharmacies, and distributors of all immediate-release transmucosal fentanyl products will be able to use standardized materials and a single shared system to implement the REMS,” notes John Jenkins, M.D., director of FDA’s Office of New Drugs in the Center for Drug Evaluation and Research.

FDA has requested that all immediate-release fentanyl products are brought under a single REMS model and then within a single REMS system within 2011, ProStrakan points out. The firm anticipates the Abstral REMS will be similar to the class-wide REMS for all immediate-release fentanyl products.

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