BioDelivery Sciences has resubmitted its NDA for the its lead product Onsolis to the 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.
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