Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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)

Related Content

UsernamePublicRestriction

Register

PS050309

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel