BDSI Announces Acceptance of Emezine(R) NDA for Review By FDA

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,
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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).
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