US FDA delays ProStrakan's Abstral approval

Galashiels, Scotland-based ProStrakan said yesterday that the US Food and Drug Administration has extended the review period under the Prescription Drug User Fee Act for its cancer pain drug Abstral (fentanyl)  by three months.

The FDA has issued the extension following its earlier request for additional information on the Abstral Risk Evaluation and Mitigation Strategy (REMS). ProStrakan says it has submitted this information.

Abstral is a rapidly-disintegrating tablet for sub-lingual administration of fentanyl intended for the management of breakthrough pain in cancer patients who are already receiving opioid analgesics for their underlying persistent cancer pain.