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BioDelivery discusses Onsolis REMS with FDA

Executive Summary

BioDelivery Sciences will meet with FDA Nov. 17 to discuss its proposed Risk Evaluation and Mitigation Strategy for Onsolis (buccal fentanyl). In August, BioDelivery received a complete response letter from FDA requesting the conversion of its RiskMAP to a REMS, but said all other aspects of the company's NDA were complete (1"The Pink Sheet" DAILY, Aug. 28, 2008). BioDelivery CEO Mark Sirgo said the company had been anticipating the agency's request for a REMS and had been proactively evaluating a series of options even before the complete response letter was sent. Onsolis, formerly known as BEMA Fentanyl, is a potential treatment for breakthrough pain in opioid-tolerant cancer patients. BioDelivery said it expects to submit the REMS in December and anticipates FDA approval in the first half of 2009. Approval may in fact hinge on validation of a risk management plan used for a rival fentanyl product, Cephalon's Fentora. Cephalon is seeking to expand Fentora's indication from cancer patients to breakthrough pain in general, but FDA wants the firm to put its new COVERS risk management system into place first for the existing use in order to establish its utility (2"The Pink Sheet" DAILY, Sept. 15, 2008)

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