REMS Daily Archives
Abstral® launched and now available in the United States
Apr 4, 2011Uppsala, April 4, 2011 - Orexo AB (STO: ORX) announces today that its partner ProStrakan Group plc (LSE: PSK) has launched Abstral in the United States.
Abstral, which is the only fast-acting sublingual tablet for the treatment of breakthrough cancer pain, is now available to patients in the US. In 2010 the market value for fast-acting fentanyl products was $530m. (Source: Wolter Kluwers).
Abstral was approved by the US Food and Drug Administration (FDA) in January 2011, and is the first product to be approved in the US with the FDA mandated class Risk Evaluation and Mitigation Strategy (REMS) for transmucosal immediate release fentanyl products. The Abstral REMS allows appropriate prescriptions to be filled at retail pharmacies as well as providing access to the product within hospitals.
