Fentora viewed as approvable by US FDA

US biopharmaceutical firm Cephalon said that its drug Fentora (fentanyl buccal tablet) has received an approvable letter from the Food and Drug Administration. The product, which is intended for the treatment of breakthrough pain in opioid-tolerant cancer patients, utilizes Cephalon's proprietary OraVescent delivery technology.The FDA has indicated that no additional safety or efficacy data are required and that the labelling has been essentially finalized.

The New Drug Application that Cephalon submitted contained data from 13 clinical studies, including a pivotal trial which showed that Fenmtora brought about a clinically-significant reduction in pain intensity in treated cancer patients. In addition, a Phase III assessment of the product demonstrated that it was generally well tolerated, with the most common adverse events observed being those usually associated with other opioid-based pain treatments (e,g nausea, dizziness, headache, fatigue etc).

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