Abstral (fentanyl transmucosal immediate-release tablets, from ProStrakan) has been approved by the FDA for the management of breakthrough pain in adult patients with cancer, ≥18 years old, who already use opioid pain medication around the clock and who need and are able to safely use high doses of an additional opioid medicine. Fentanyl immediate-release transmucosal medications are administered on the soft surfaces of the mouth where they dissolve and are absorbed. This approval was based on data from a study conducted in 311 opioid-tolerant cancer patients with breakthrough pain.
Abstral will be available only 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 expected to be available early in the first quarter of 2011 in 100mcg, 200mcg, 300mcg, 400mcg, 600mcg, and 800mcg dosage strengths.
For more information call (908) 234-1096 or visit www.prostrakan.com.