BioDelivery Sciences International, Inc. announced that it has resubmitted its New Drug Application (NDA) for the company's lead product Onsolis to the Food and Drug Administration (FDA). The company continues to anticipate that the resubmission, which includes a Risk Evaluation and Mitigation Strategy (REMS) for Onsolis, will be approved in the first half of 2009.
Onsolis (formerly known as BEMA Fentanyl), the company's lead product in development, is a potential treatment for "breakthrough" pain in opioid tolerant patients with cancer. In North America and Europe, the commercial rights to Onsolis are licensed to Meda AB.
In August 2008, BDSI received a complete response letter from the FDA regarding the NDA for Onsolis. The FDA requested conversion of the submitted risk minimization action plan (RiskMAP) to a REMS and informed BioDelivery Sciences that all other aspects of the NDA review were complete.
"We have moved quickly to finalize our REMS programme together with our partner Meda and submit it to FDA for formal review," said Dr. Mark A. Sirgo, president and chief executive officer of BDSI. "We are confident that our proposed REMS programme is consistent with the advice we received in our complete response letter and further discussed during our recent meeting with the FDA. We look forward to continuing to work with FDA to expeditiously achieve approval of Onsolis."
BioDelivery Sciences International, Inc. is a specialty pharmaceutical company that is focused on developing innovative products to address growing market opportunities, including conditions such as pain.