BioDelivery Sciences Submits REMS For ONSOLIS To FDA For Approval

Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Pain / Anesthetics;  Cancer / Oncology
Article Date: 23 Dec 2008 - 1:00 PDT

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BioDelivery Sciences International, Inc., (NASDAQ:BDSI) 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 program 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 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."

About BioDelivery Sciences International

BioDelivery Sciences International, Inc. (NASDAQ:BDSI) is a specialty pharmaceutical company that is focused on developing innovative products to address growing market opportunities, including conditions such as pain. The company utilizes its owned and licensed patented drug delivery technologies to develop, partner, and commercialize new products using proven therapeutics. BDSI's pain franchise currently consists of two products in development utilizing the Company's patented BEMA buccal soluble film technology: ONSOLIS, a potential treatment for "breakthrough" pain in opioid tolerant patients with cancer, and BEMA Buprenorphine, a second analgesic with at least one potential target indication for the treatment of moderate to severe pain. The company is working with its BEMA technology and its patented Bioral® cochleate technology on products targeted at conditions common to oncology and surgical patients such as pain and infections. The company headquarters is located in Raleigh, North Carolina, and its principal laboratory is located in Newark, New Jersey. For more information please visit http://www.biodeliverysciences.com.

Cautionary Note on Forward-Looking Statements

Except for the historical information contained herein, this press release and the statements of representatives and partners of BioDelivery Sciences International, Inc. (the "Company") related thereto contain or may contain, among other things, certain forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects", "may", "could", "would", "should", "believes", "expects", "anticipates", "estimates", "intends", "plans" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results, including, without limitation: (i) actual sales results and royalty or milestone payments, if any, (ii) the application and availability of corporate funds and the Company's need for future funds, or (iii) the timing for completion, and results of, scheduled or additional clinical trials and the FDA's or other regulatory review and/or approval and commercial launch of the Company's formulations and products and regulatory filings related to the same, may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control).

Source:
Al Medwar
BioDelivery Sciences International, Inc.