BioDelivery Sciences Announces BEMA Buprenorphine NDA Submission on Track
following Pre-NDA Meeting with FDA
BEMA Buprenorphine on track for late 2014 or early 2015 NDA filing by partner
RALEIGH, N.C., Aug. 12, 2014
RALEIGH, N.C., Aug. 12, 2014 /PRNewswire/ --BioDelivery Sciences
International, Inc. (NASDAQ: BDSI) announced that along with its commercial
partner, Endo Pharmaceuticals, engaged in a positive pre-New Drug Application
(NDA) meeting with the U.S. Food and Drug Administration (FDA) regarding BEMA
Buprenorphine for the management of pain severe enough to require daily,
around-the-clock, long-term opioid treatment for which alternative treatment
options are inadequate. The meeting was held on July 15 and meeting minutes
have been received.
The positive outcome of the pre-NDA meeting allows BDSI and Endo to maintain
expectations of an NDA filing with FDA for BEMA Buprenorphine in late 2014 or
early 2015 as planned.
The scheduled meeting with FDA regarding the NDA submission for BEMA
Buprenorphine was undertaken to review the key data elements for the NDA and
follows the successful completion of two Phase 3 clinical studies of BEMA
Buprenorphine. Both studies yielded positive top-line results and
demonstrated that BEMA Buprenorphine significantly improved chronic pain
relief compared to placebo in a study of opioid naive patients (p<0.005) and
in a study of opioid experienced patients (p<0.0001). Secondary endpoints
were also supportive of the efficacy.
"We are pleased to be progressing another product toward an NDA submission,"
said Dr. Andrew Finn, Executive Vice President of Product Development. "We
will continue to work closely with our partner Endo Pharmaceuticals as they
prepare the NDA submission for late this year or early next year."
About BioDelivery Sciences International
BioDelivery Sciences International, Inc. (NASDAQ:BDSI) is a specialty
pharmaceutical company with a focus in the areas of pain management and
addiction medicine. BDSI is utilizing its novel and proprietary BioErodible
MucoAdhesive (BEMA^®) technology and other drug delivery technologies to
develop and commercialize, either on its own or in partnership with third
parties, new applications of proven therapies aimed at addressing important
unmet medical needs.
BDSI's development strategy focuses on utilization of the FDA's 505(b)(2)
approval process. This regulatory pathway creates the potential for more
timely and efficient approval of new formulations of previously approved
BDSI's particular area of focus is the development and commercialization of
products in the areas of pain management and addiction. These are areas where
BDSI believes its drug delivery technologies and products can best be applied
to address critical unmet medical needs. BDSI's marketed products and those
in development address serious and debilitating conditions such as
breakthrough cancer pain, chronic pain, painful diabetic neuropathy and opioid
BDSI's headquarters is located inRaleigh, North Carolina.
For more information visitwww.bdsi.com.
BDSI can now be followed on Facebook (Facebook.com/BioDeliverySI) and Twitter
Cautionary Note on Forward-Looking Statements
This press release, the interview described and presented herein, and any
statements of representatives and partners of BioDelivery Sciences
International, Inc. (the "Company") related thereto (including, without
limitation, at the presentations described herein) 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," "will," "could," "would,"
"should," "believes," "expects," "anticipates," "estimates," "intends,"
"plans," "potential" 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 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). The Company undertakes no obligation
to publicly update any forward-looking statements, whether as a result of new
information, future events or otherwise, except as required by applicable law.
BDSI^®and BEMA^®are registered trademarks of BioDelivery Sciences
International, Inc. The BioDelivery Sciences logo and BUNAVAIL™ are
trademarks owned by BioDelivery Sciences International, Inc. ONSOLIS^®is a
registered trademark of Meda Pharmaceuticals, Inc. BREAKYL™ is a trademark
owned by Meda Pharma GmbH & Co. KG. PAINKYL™is a trademark owned by TTY
Biopharm. All other trademarks and tradenames are owned by their respective
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SOURCE BioDelivery Sciences International, Inc.
Contact: Brian Korb, Senior Vice President, The Trout Group LLC, (646)
378-2923, firstname.lastname@example.org; or Al Medwar, Vice President, Marketing and
Corporate Development, BioDelivery Sciences International, Inc., 919-582-9050,
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