EmezineTreatment for Nausea/Vomiting
BDSI Announces Submission of NDA for Emezine; First Transmucosal Product for the Treatment of Nausea and Vomiting
MORRISVILLE, N.C., 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, a formulation of prochlorperazine, a currently approved agent for the treatment of nausea and vomiting. Emezine 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, 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 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.
Dr. Andrew L. Finn, BDSI's Executive Vice President of Clinical Development and Regulatory Affairs, said "We believe that Emezine 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 project, including the assistance of Reckitt Benckiser, from whom we license Emezine, 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 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 Fentanyl, into Phase III clinical trials for the treatment of breakthrough cancer pain this year."
BioDelivery Sciences International, Inc. is a specialty biopharmaceutical company that is exploiting its licensed and patented drug delivery technologies to develop and commercialize, or partner with third parties on, clinically-significant new formulations of proven therapeutics, nutraceuticals and micronutrients. The company's drug delivery technologies include: (i) the patented Bioral nanocochleate technology, designed for a potentially broad base of applications, and (ii) the patented BEMA (transmucosal or mouth) drug delivery technology being developed by the company's Arius Pharmaceuticals subsidiary. Arius is developing products for the "acute" treatment opportunities such as pain, anxiety, nausea and vomiting, and infections. The company's headquarters are located in Morrisville, North Carolina and its principal laboratory is located in Newark, New Jersey.
Posted: May 2005
- BioDelivery Sciences Receives Non-Approvable Notification from FDA on Emezine; Company Has Requested a Meeting with the FDA to Gain Clarity on Notification - March 1, 2006
- BDSI Announces Acceptance of Emezine NDA for Review By FDA - July 20, 2005