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BioDelivery Sciences Receives Non-Approvable Notification from FDA on Emezine® |
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02 Mar 2006 |
Company Has Requested a Meeting with the FDA to Gain Clarity on Notification
MORRISVILLE, NC, USA | Mar 01, 2006 | BioDelivery Sciences International, Inc. (NASDAQ:BDSI - News), a specialty biopharmaceutical company, has received a non-approvable letter from the U.S. Food and Drug Administration (FDA) for the company's new drug application (NDA) for Emezine®, a buccal tablet formulation of prochlorperazine maleate for the treatment of severe nausea and vomiting. The letter was received on February 28, 2006.
The non-approvable letter stated that additional information would be required to address remaining questions. BDSI has requested a meeting with the FDA regarding their notification and will use the outcome of this meeting to evaluate the direction it intends to pursue regarding Emezine®.
Dr. Mark A. Sirgo, President and CEO of BDSI, stated, "We are extremely surprised and disappointed by the FDA's decision in light of the fact that we strictly adhered to the development program that was outlined in our pre-NDA meeting with the FDA in March of 2004. It is clear based on the FDA's comments that they are now, among other things and contrary to our previous expectations, seeking additional data on the product. We will take the next few days, in conjunction with our licensing and distribution partners, to consider our options in responding to and working with the FDA on this matter.
We have put in a meeting request today and plan to act quickly to resolve the situation. In the meantime, we will maintain focus on our flagship BEMA™ Fentanyl product, which is now progressing through Phase III, and on the other products and formulations in our pipeline."
Emezine® is an oral transmucosal (drug absorbed directly through the mucosa of the mouth) medication for the treatment of nausea and vomiting. The current alternatives to oral tablets are injections and suppositories. BDSI licenses Emezine® on an exclusive basis in the U.S. from Reckitt Benckiser Healthcare (UK) Limited. The Emezine® tablets are proposed to be manufactured for BDSI by Reckitt Benckiser, which currently distributes a similar product in the United Kingdom. TEAMM Pharmaceuticals, a subsidiary of Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI - News), has contracted to be BDSI's distribution partner for Emezine®.
BDSI is also working on BEMA™ Fentanyl, a treatment for "breakthrough" cancer pain, and expects to complete its Phase III BEMA™ Fentanyl trials during the second half of 2006. BEMA™ Fentanyl is an oral adhesive disc formulation of the narcotic fentanyl. Additionally, BDSI will be conducting Phase I trials with BEMA™ LA, its second analgesic in the BEMA™ technology, in the first quarter of 2006 and plans to initiate Phase III trials in the second half of 2006.
SOURCE: BioDelivery Sciences International, Inc |
