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Prochlorperazine NDA Submitted to FDA, First Transmucosal Product for Nausea and Vomiting

MORRISVILLE, N.C.--(BUSINESS WIRE)--May 2, 2005--BioDelivery Sciences International, Inc. (NASDAQ:BDSI) (NASDAQ:BDSIW), announced today that it has submitted a new drug application (NDA) to the U.S. Food and Drug Administration for Emezine(R), a formulation of prochlorperazine, a currently approved agent for the treatment of nausea and vomiting. Emezine(R) is conveniently administered by placing the dissolving tablet between the upper lip and gum, thereby delivering the drug across the membrane of the mouth. To the best of BDSI's knowledge, Emezine(R), if approved by the FDA, would be the first and only transmucosal medication for nausea and vomiting in the United States.

BDSI believes that Emezine(R) will give physicians a patient-friendly alternative to injections or suppositories for the treatment of nausea and vomiting associated with a wide range of conditions such as surgery, chemotherapy and migraine attacks. In February 2005, BDSI announced that it had completed the clinical studies required for an NDA on Emezine(R).

Dr. Andrew L. Finn, BDSI's Executive Vice President of Clinical Development and Regulatory Affairs, said "We believe that Emezine(R) is a product that will address a growing and presently unserved need in the marketplace, and we are very hopeful that the FDA will find our submission acceptable for filing. We believe we have adhered to the requirements we agreed upon with the FDA at our pre-NDA meeting last year. We are also very pleased with the tremendous team effort behind our Emezine(R) project, including the assistance of Reckitt Benckiser, from whom we license Emezine(R), and great planning and execution by our own BDSI staff. We are proud that this effort allowed us to move from the finalization of our development plan to a NDA submission in 12 months."

Dr. Mark A. Sirgo, BDSI's President and COO, said "This is a major achievement for our company. It validates our business model of applying the FDA's streamlined 505(b)(2) approval process to move proven therapeutics, which are then combined with delivery technologies, through the development pipeline. In addition, the filing of this NDA, which is the first for BDSI, is a testament to our ability as an organization to follow through on our announced plans. Dr. Finn did an extraordinary job in executing the development plan for Emezine(R) and meeting the corporate timeline for this significant FDA submission. With this submission behind us, we will now concentrate efforts on moving our next product, BEMA(TM) Fentanyl, into Phase III clinical trials for the treatment of breakthrough cancer pain this year."

Source: BioDelivery Sciences International, Inc.

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