The FDA will now have sixty days in which to consider the new drug application (NDA) for filing. If accepted for filing, the FDA will have an additional eight months to complete the review of the application. As a result, BioDelivery Sciences International (BDSI) expects a final decision in August 2008.
If approved, BDSI is expected to receive milestone payments from US commercialization partner Meda totaling $30 million, and could begin receiving royalty revenues from the product as early as the fourth quarter of 2008.
Dr David Wright, director of regulatory affairs at BDSI, said: “Our team has been very diligent in following the FDA’s guidance on the development of BEMA Fentanyl and the preparation of the NDA. Given the nature of our pre-submission communications with the FDA, we anticipate a very interactive review process over the next ten months.”