BioDelivery Sciences International, a specialty pharmaceutical company, has received a complete response letter from the FDA regarding the company's new drug application for Bema Fentanyl, which will be marketed in the U.S. market as Onsolis, a potential treatment for 'breakthrough' pain (i.e., episodes of severe pain which "break through" the medication used to control the persistent pain).

The FDA has requested that the company make modifications to the submitted risk management program.

The company will submit the requested information and anticipates approval in the first half of 2009.

Onsolis (fentanyl buccal soluble film) consists of a small, dissolvable, polymer film, formulated with the opioid narcotic fentanyl for application to the buccal mucosa (inner lining of the cheek). Fentanyl belongs to the group of medicines called narcotic analgesic.