The company continues to anticipate that the resubmission, which includes a risk evaluation and mitigation strategy 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.
In August 2008, BioDelivery Sciences International (BDSI) received a complete response letter from the FDA regarding the new drug application (NDA) for Onsolis. The FDA requested conversion of the submitted risk minimization action plan to a risk evaluation and mitigation strategy (REMS) and informed BDSI that all other aspects of the NDA review were complete.
Mark Sirgo, president and CEO of BDSI, said: We have moved quickly to finalize our REMS program together with our partner Meda and submit it to FDA for formal review.
We are confident that our proposed REMS program 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.