BioDelivery Sciences Provides NDA Update for ONSOLIS

BioDelivery
Sciences International, Inc. (Nasdaq: BDSI | Quote | Chart | News | PowerRating) today announced that the
company has reached agreement with the U.S. Food and Drug
Administration's (FDA) Division of Anesthesia, Analgesia and
Rheumatology Products and a multidisciplinary review team on all aspects
of the company's New Drug Application (NDA) for ONSOLIS(TM)
(fentanyl buccal soluble film), including the Risk Evaluation and
Mitigation Strategy (REMS). Although the FDA did not meet its action
date of last Friday for this NDA, the Division has informed the company
that FDA will not be issuing a review extension letter as their action
on the NDA is forthcoming.

BDSI received a Complete Response letter from FDA on the NDA for ONSOLIS
on August 28, 2008, with the only deficiency being the new requirement
for a REMS. The REMS was not required at the time the NDA was originally
submitted to FDA in October 2007. The REMS was formally submitted to the
FDA on December 12, 2008 and the submission was placed under a six month
review period.

"FDA informed us on Friday that given how close they are to taking their
action, they saw no need for issuing a review extension letter, which
would have formally given them more time to complete their review. In
other words, they simply need a little more time, which we believe is
not inconsistent with other recent NDA approvals for other products at
the Agency where a REMS was required for approval," stated Dr. Mark A.
Sirgo, President and CEO of BioDelivery Sciences. "We view this as
positive news, together with the fact that we have reached agreement
with the reviewing division and the review team on all aspects of our
NDA, including our REMS. Our dialog and working relationship with the
reviewing division have been outstanding and have been fundamental to
the progress we have made in working with them in this significant
undertaking, to complete the first 'opioid' REMS and the first REMS for
this Division. We look forward to FDA's forthcoming action," stated Dr.
Sirgo.

"Although we can not pinpoint the exact timing of when the FDA's action
might occur, we have previously indicated that we expect a first half
2009 approval of the NDA for ONSOLIS. Based on our discussion with FDA
last Friday, we should be within a few weeks of that target."

Dr. Sirgo continued, "As it relates to BDSI's current financial
position, we are pleased to announce that over the last several weeks we
have received funds from the exercise of certain outstanding warrants.
The receipt of these funds alone should allow us to comfortably manage
the company into the fourth quarter of this year, including the
continued advancement of our pipeline, without any additional financing
required."

BDSI will hold a webcast to discuss the NDA status of ONSOLIS on
June 15, 2009 at 11:00 a.m. Eastern time. Participants are invited to
access the live webcast by dialing (877) 407-8033 or from the company's
website at www.biodeliverysciences.com.

About BioDelivery Sciences International

BioDelivery Sciences International, Inc. (NASDAQ:BDSI) is a specialty
pharmaceutical company that is focused on developing innovative products
to address growing market opportunities, including conditions such as
pain. The company utilizes its owned and licensed patented drug delivery
technologies to develop, partner, and commercialize new products using
proven therapeutics. BDSI's pain franchise utilizes the Company's
patented BEMA(TM) buccal soluble film technology and currently
consists of: ONSOLIS (fentanyl buccal soluble film) under FDA review for
"breakthrough" pain in opioid tolerant patients with cancer, and BEMA
Buprenorphine, a second analgesic in development with at least one
potential target indication for the treatment of moderate to severe
pain. The company is working with its BEMA and Bioral(TM)
technologies on products targeted at conditions common to oncology and
surgical patients such as pain and infections. The company headquarters
is located in Raleigh, North Carolina, and its principal laboratory is
located in Newark, New Jersey. For more information please visit www.biodeliverysciences.com.

Cautionary Note on Forward-Looking Statements

This press release and the statements of representatives and partners of
BioDelivery Sciences International, Inc. (the "Company") related thereto
contain, or may contain, among other things, certain "forward-looking
statements" within the meaning of the Private Securities Litigation
Reform Act of 1995. Such forward-looking statements involve significant
risks and uncertainties. Such statements may include, without
limitation, statements with respect to the Company's plans, objectives,
projections, expectations and intentions and other statements identified
by words such as "projects," "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, including, without limitation, those relating to the timing for
completion, and results of, scheduled or additional clinical trials and
the FDA's or other regulatory review and/or approval, and commercial
launch and sales results (if any), of the Company's formulations and
products and regulatory filings related to the same, and receipt by the
Company of milestone or other payments from third parties, may differ
significantly 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).

SOURCE: BioDelivery Sciences International, Inc.

BioDelivery Sciences International, Inc. 
Al Medwar, 919-582-9050 
Vice President, Marketing & Corporate Development 
amedwar@bdsinternational.com 
or 
Fran Barsky, 919-582-9050 
Investor Relations 
fbarsky@bdsinternational.com

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