BDSI Announces Acceptance of Emezine(R) NDA for Review By FDA
20 7월 2005 - 11:28PM
Business Wire
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(R) 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(R) is 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. BDSI
has the exclusive U.S. rights to Emezine(R) under a license
agreement with Reckitt Benckiser Healthcare (UK) Limited. The FDA's
review of Emezine(R) 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(R) 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(R) Amphotercin B." BioDelivery Sciences
International, Inc. is a specialty biopharmaceutical company that
is exploiting its licensed and patented drug delivery technologies
to develop and commercialize, either on its own or in partnerships
with third parties, clinically-significant new formulations of
proven therapeutics targeted at "acute" treatment opportunities
such as pain, anxiety, nausea and vomiting and infections. 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. 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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