Cephalon aims to launch its COVERS pilot program for the pain drug Fentora later this year and says FDA is likely to require comparable enhanced risk management for its off-patent opiate Actiq and generic versions of that product.

Based on talks so far with the agency, the firm expects to test the Controlled Voice Enrollment Registration System in Fentora's current indication of pain in opioid-tolerant cancer patients, the firm said in a July 29 second quarter earnings call. Data from the pilot program will support the firm's struggling supplemental NDA for an expanded indication in breakthrough pain in non-cancer patients.

However, the plan cannot be finalized until FDA provides a complete response on the sNDA, due in mid-September, said Frazer, Pa.-based Cephalon.

Since Fentora (fentanyl buccal tablet) and Actiq (oral transmucosal fentanyl citrate) are similar, it makes sense to put both products under the same risk management umbrella, Cephalon said.

"Our expectation is that the agency will ask us to apply coverage to Actiq as well. We think that's the right thing to do for patients and we are looking forward to doing that," said CEO Frank Baldino during the call. "We also believe COVERS will be a mandated application to all rapid-onset opiates. We think it's an important safety feature for this class of product. We expect the agency to require it."

Those required to comply would include makers of Actiq generics, the executive elaborated.

Cephalon introduced COVERS during a review of the Fentora sNDA by FDA's Anesthetic and Life Support Drugs and Drug Safety and Risk Management Advisory Committee in May. Concerned about widespread problems with misuse, the committee voted 17-3 against approving the expanded indication, and members called for tighter control of current use in cancer patients (¹ Also see "The Role Of RiskMAPs: Fentora Shows Shift From Post-Market To Pre-Market" - Pink Sheet, 12 May, 2008. p. 3).

The program would create an electronic usage registry for physicians, patients and pharmacists, limiting drug access to select clinicians.

- Emily Hayes (e.hayes@elsevier.com)

Cephalon’s Proposed Fentora Controls May Extend To All Rapid-Onset Opiates

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