EmezineTreatment for Nausea/Vomiting
BDSI Announces Acceptance of Emezine NDA for Review By FDA
MORRISVILLE, N.C., July 20, 2005 - BioDelivery Sciences International, Inc. (NASDAQ:BDSI) (NASDAQ:BDSIW) announced today that it has received written notification from the U.S. Food and Drug Administration that its new drug application (NDA) for Emezine has been accepted for review. BDSI previously announced that it filed such NDA in late April 2005, and this written notification indicates that FDA review of the product is now underway. Under FDA regulations, the FDA has up to 10 months from the date of NDA submission to review and render a decision on the application as to whether it is approvable or not.
Emezine is 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. BDSI has the exclusive U.S. rights to Emezine under a license agreement with Reckitt Benckiser Healthcare (UK) Limited.
The FDA's review of Emezine is being undertaken through the FDA's 505(b)(2) approval process. Under this process, a company is able to seek FDA approval of a new dosage form, dosage regimen or new indication of a pharmaceutical that has previously been approved by the FDA. This regulation enables a company to partially rely on the findings of third parties which the FDA has published on approved pharmaceuticals, including clinical and non-clinical testing, thereby reducing, though not eliminating, the need to engage in these costly and time consuming activities.
Dr. Mark A. Sirgo, BDSI's President and COO, said: "We are very gratified that the review process for Emezine is underway and we look forward to working with the FDA on this project. We are equally gratified that we have been able to continue the execution of our publicly-announced plans. As we move into the second half of 2005, we hope to continue this trend with our entry into our Phase III program with BEMA(TM) Fentanyl and the filing our IND and first human trial for Bioral Amphotercin B."
For more information, please visit the BioDelivery Sciences International, Inc. website.
Posted: July 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 Submission of NDA for Emezine; First Transmucosal Product for the Treatment of Nausea and Vomiting - May 2, 2005