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News Release

BioDelivery Sciences Announces Presentation of Data on the Impact of a State Formulary Conversion to BUNAVAIL® at the International Conference on Opioids

July 6, 2016 at 12:00 AM EDT

RALEIGH, N.C., June 6, 2016 /PRNewswire/ -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI) announced the presentation of data today at the 5th International Conference on Opioids (ICOO 2016), which takes place June 5-7, 2016 in Boston, Massachusetts.  The poster is being presented by Dr. Richard Soper, Chief, Addiction Medicine & Chair, Board of Directors, Center for Behavioral Wellness, Nashville, Tennessee, who is lead author.

The abstract, titled Reduced Buprenorphine/Naloxone Prescriptions Dispensed in a State Medicaid Population Following Formulary Conversion from Suboxone to Bunavail: Implications for Potential Diversion, analyzed prescription patterns preceding and following a complete switch of prescriptions covered by Medicaid in the State of Tennessee on October 1, 2015 from Suboxone® sublingual film to BUNAVAIL® buccal film.  This switched occurred following the implementation of a formulary change making BUNAVAIL the exclusive, preferred buprenorphine treatment for opioid dependence in this major fee-for-service state Medicaid plan.

Results showed prescriptions of Suboxone decreased from a weekly consistent peak of more than 1,600 to less than 100 within one month of the switch, while BUNAVAIL prescriptions increased from a low of 19 to approximately 600. This approximate 63 percent reduction in overall prescriptions in the plan remained throughout the measurement period, which may result in a savings of approximately $14 million to the state budget.  This real-world switch with a more than 60 percent reduction in overall buprenorphine prescriptions in the state suggests that a significant amount of prior product use may not have been used for the intended patient (a phenomenon known as diversion) or for its intended purpose (i.e., for the maintenance treatment of opioid dependence) as opposed to misuse or abuse of the product.

Dr. Soper stated "Medication-assisted therapy is an important part of helping patients manage and overcome opioid addiction, yet it needs to be done responsibly. The data presented suggests that the BUNAVAIL formulation of buprenorphine and naloxone, when made available, has a meaningful impact on overall usage and may be discouraging those who otherwise might not have been using the medication in a responsible manner. Prescribers should consider the potential for diversion when prescribing a treatment and should make every effort to minimize it."

Dr. Mark A. Sirgo, President and Chief Exec of BioDelivery Sciences said, "BUNAVAIL, with its buccal administration, has been shown to be capable of delivering the same amount of buprenorphine with only half of the dose delivered with other formulations. In addition, when these doctors were surveyed, over 60% indicated that they believe BUNAVAIL is more difficult to abuse based on the BEMA technology.  Overall this information, in totality, leads us to believe that our unique and proprietary BEMA drug delivery technology, incorporated into BUNAVAIL, could make it less attractive for those who may be otherwise inclined to potentially misuse, abuse, or divert their treatment.  We look forward to continuing our ongoing efforts to work effectively with providers and payers in additional states and regions around the country, and believe that our experience with BUNAVAIL in Tennessee is a model we can apply in other states." 

The International Conference on Opioids is presented by the Journal of Opioid Management.  The program is led by renowned specialists and is designed to inform primary care physicians, pain specialists, pharmacists and others with an interest in opioids and the public health, with data and information on best practices, abuses and legal ramifications of opioids.

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 therapeutics.

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 dependence.  BDSI's headquarters is located in Raleigh, North Carolina.  

 

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BUNAVAIL® (buprenorphine and naloxone) buccal film (CIII) is marketed in the U.S. by BioDelivery Sciences.  BELBUCA™ (buprenorphine) buccal film (CIII) is commercialized in the U.S. by Endo Pharmaceuticals pursuant to the worldwide licensing and development agreement between BDSI and Endo.  ONSOLIS® (fentanyl buccal soluble film) (CII) is commercialized in the U.S. by Collegium Pharmaceutical pursuant to the U.S. licensing and development agreement between BDSI and Collegium. For full prescribing information and important safety information on BDSI products, including BOXED WARNINGS for ONSOLIS, please visit www.bdsi.com where the Company promptly posts press releases, SEC filings and other important information or contact the Company at (800) 469-0261.  For full prescribing and safety information on BELBUCA, please visit www.belbuca.com.

Cautionary Note on Forward-Looking Statements

This press release, the presentations described herein, and any statements of employees, representatives and partners of BioDelivery Sciences International, Inc. (the "Company") related thereto (including, without limitation, at the presentation 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 (including, without limitation, the impact of state formulary programs on the commercialization of BUNAVAIL and the ability of the Company to secure additional state formulary contracts as described herein) 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 presentations or otherwise, except as required by applicable law.

BDSI®, BEMA®, ONSOLIS® and BUNAVAIL® are registered trademarks of BioDelivery Sciences International, Inc.  The BioDelivery Sciences and BUNAVAIL logos are trademarks owned by BioDelivery Sciences International, Inc.  BELBUCA™ is a trademark owned by Endo Pharmaceuticals.  All other trademarks and tradenames are owned by their respective owners.

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SOURCE BioDelivery Sciences International, Inc.

For further information: Investors: Matthew P. Duffy, Managing Director, LifeSci Advisors, LLC, 212-915-0685, matthew@lifesciadvisors.com; Al Medwar, Senior Vice President, Corporate and Business Development, BioDelivery Sciences International, Inc., 919-582-9050, amedwar@bdsi.com; Media: Susan Forman/Laura Radocaj, Dian Griesel Int'l., 212-825-3210, sforman@dgicomm.com, lradocaj@dgicomm.com