US FDA finally approves ProStrakan opioid analgesic Abstral

After several delays due to safety concerns, the US Food and Drug Administration on Friday finally agreed to approve Scotland-based ProStrakan’s (LSE: PSK) Abstral (fentanyl) transmucosal tablets to manage breakthrough pain for adults with cancer.

However, Abstral will only be available through a Risk Evaluation and Mitigation Strategy (REMS) program, which is intended to minimize the risk of misuse, abuse, addiction and overdose. Under this program, pharmacies, distributors and health care professionals who prescribe to outpatients are required to enroll in the program to prescribe, dispense and distribute this product.

Abstral is already marketed in the UK, Germany, France and Spain, where it achieved sales of some £17 million ($26.5 million) in the first full year of commercial operations, said ProStraken this morning. The company said it expects to launch Abstral in the USA in early first-quarter 2011 - its second oncology product launch in the USA. Launch preparations are at an advanced stage and sales teams have already completed a significant level of training. Abstral will be the only rapidly disintegrating sublingual tablet for breakthrough cancer pain on the US market, where the overall annual market value for immediate release fentanyl products is $550 million (Source: Wolter Kluwers, August 2010. MAT), the firm stated.