BDSI Announces Submission of NDA for Emezine; First Transmucosal Product for the Treatment of Nausea and Vomiting
May 02 2005 - 6:30AM
Business Wire
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." 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(R) nanocochleate
technology, designed for a potentially broad base of applications,
and (ii) the patented BEMA(TM) (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. Note: Except for the historical information
contained herein, this press release contains, among other things,
certain forward-looking statements, within the meaning of the
Private Securities Litigation Reform Act of 1995, that involve
risks and uncertainties. Such statement may include, without
limitation, statements with respect to the Company's plans
(including, without limitation, its initiation of clinical trials
and the FDA approval process), objectives, expectations and
intentions and other statements identified by words such as "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 may
differ 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). L.G. Zangani, LLC
provides financial public relations service to the Company. As such
L.G. Zangani, LLC and/or its officers, agents and employees,
receives remuneration for public relations and or other services in
the form of monies, capital stock in the Company, warrants or
options to purchase capital in the Company.
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