RALEIGH, N.C., June 11, 2014 /PRNewswire/ -- Dr. Mark A. Sirgo, President and Chief Executive Officer of BioDelivery Sciences International, Inc. (NASDAQ: BDSI) was interviewed on Bloomberg TV, TheStreet.com and Business News Network on June 11 regarding BUNAVAIL, BDSI’s product for the maintenance treatment of opioid dependence that recently received approval from the U.S. Food and Drug Administration.
In the interviews, Dr. Sirgo discussed a series of topics, including the size of the opioid dependence market, the potential of BUNAVAIL to address the growing problem of opioid dependence and how the buccal formulation and method of delivery (a thin film that adheres to the inside of the cheek) may give BUNAVAIL a specific advantage over other treatments for opioid addiction.
To view the Bloomberg TV interview, titled “Is Bunavail the Answer to the Opioid Drug Epidemic?” in its entirety, please visit the following link:
To view TheStreet.com interview, titled “BioDelivery CEO: Opioid Dependence Treatment Ready to Take Off,” in its entirety, please visit the following link: http://www.thestreet.com/_yahoo/video/12739939/biodelivery-ceo-opioid-dependence-treatment-ready-to-take-off.html?cm_ven=YAHOOV&cm_cat=FREE&cm_ite=NA&s=1
To view the Business News Network interview, titled “Healthcare Report: BioDelivery Gets FDA OK for Opioid Treatment,” in its entirety, please visit the following link: http://www.bnn.ca/Video/player.aspx?vid=378826
The videos at the links above are provided for informational purposes only. BioDelivery Sciences International, Inc. is not responsible for the content of the linked videos.
INDICATION|
BUNAVAIL (buprenorphine and naloxone) Buccal Film (CIII) is a prescription medicine indicated for the maintenance treatment of opioid dependence. BUNAVAIL should be used as part of a complete treatment plan to include counseling and psychosocial support.
Prescription use of this product is limited under the Drug Addiction Treatment Act (DATA).
IMPORTANT SAFETY INFORMATION
Keep BUNAVAIL (buprenorphine and naloxone) Buccal Film (CIII) out of the sight and reach of children. Ingestion of BUNAVAIL by a child may cause severe breathing problems and death. If a child takes BUNAVAIL, get emergency help right away.
Do not take BUNAVAIL if you are allergic to buprenorphine or naloxone, as serious negative effects including anaphylactic shock, have been reported.
Do not take BUNAVAIL before the effects of other opioids (e.g., heroin, methadone, oxycodone, morphine) have lessened as you may experience withdrawal symptoms.
Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how BUNAVAIL affects you.
BUNAVAIL contains buprenorphine, an opioid that can cause physical dependence. Your doctor can tell you more about the difference between physical dependence and drug addiction. Do not stop taking BUNAVAIL without talking to your doctor. You could become sick with uncomfortable withdrawal symptoms because your body has become used to this medicine.
Do not switch from BUNAVAIL to other medicines that contain buprenorphine without talking with your doctor. The amount of buprenorphine in a dose of BUNAVAIL is not the same as the amount of buprenorphine in other medicines. Your doctor will prescribe a dose of BUNAVAIL that may be different than other buprenorphine-containing medicines you may have been taking.
BUNAVAIL can cause serious lifethreatening breathing problems, overdose and death, particularly when taken by the intravenous (IV) route in combination with benzodiazepines, sedatives, tranquilizers or alcohol. You should not drink alcohol while taking BUNAVAIL, as this can lead to loss of consciousness or even death.
Like other opioids (e.g., heroin, methadone, oxycodone, morphine), BUNAVAIL may produce orthostatic hypotension (‘dizzy spells’) in ambulatory individuals.
Common side effects of BUNAVAIL include headache, drug withdrawal syndrome, lethargy (lack of energy), sweating, constipation, decrease in sleep (insomnia), fatigue and sleepiness.
Because BUNAVAIL contains naloxone, injecting BUNAVAIL may cause serious withdrawal symptoms such as pain, cramps, vomiting, diarrhea, anxiety, sleep problems, and cravings.
BUNAVAIL can be abused in a manner similar to other opioids, legal or illicit. Keep BUNAVAIL in a safe place. Do not give your BUNAVAIL to other people, it can cause them harm or even death. Selling or giving away this medicine is against the law.
BUNAVAIL is not recommended in patients with severe hepatic impairment. BUNAVAIL may be used with caution for maintenance treatment in patients with moderate hepatic impairment.
Before taking BUNAVAIL, tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking BUNAVAIL, tell your doctor immediately as there may be significant risks to you and your baby; your baby may have symptoms of withdrawal at birth.
Before taking BUNAVAIL, talk to your doctor if you are breastfeeding or plan to breastfeed your baby. BUNAVAIL can pass into your breast milk and may harm your baby. Monitor your baby for increased sleepiness and breathing problems. Your doctor should tell you about the best way to feed your baby if you are taking BUNAVAIL.
This is not a complete list of potential adverse events associated with BUNAVAIL Buccal Film. Please see full Prescribing Information for a complete list.
To report negative side effects associated with taking BUNAVAIL Buccal Film, please call 1
800-469-0261. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1800FDA1088.
For more information, please see full Prescribing Information and Medication Guide for BUNAVAIL Buccal Film (CIII).
About BioDelivery Sciences International
BioDelivery Sciences International (NASDAQ: BDSI) is a specialty pharmaceutical company that is leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics. BDSI is focusing on developing products to meet unmet patient needs in the areas of pain management and addiction.
BDSI’s pain franchise consists of three products, two of which utilize the patented BioErodible MucoAdhesive (BEMA) drug delivery technology. ONSOLIS (fentanyl buccal soluble film) is approved in the U.S., Canada, E.U. (where it is marketed as BREAKYL) and Taiwan (where it will be marketed as PAINKYL), for the management of breakthrough pain in opioid tolerant, adult patients with cancer. The commercial rights are licensed to Meda for all territories worldwide except for Taiwan (licensed to TTY Biopharm) and South Korea (licensed to Kunwha Pharmaceutical Co.).
BEMA Buprenorphine is in Phase 3 clinical trials for the treatment of moderate to severe chronic pain and is licensed on a worldwide basis to Endo Pharmaceuticals. Clonidine Topical Gel for the treatment of painful diabetic neuropathy is currently in Phase 3 development.
BDSI’s approved product for the maintenance treatment of opioid dependence is BUNAVAIL, which was approved by the FDA in June 2014 and is expected to be commercially launched during late third quarter 2014.
BDSI’s headquarters is located in Raleigh, North Carolina. For more information visit www.bdsi.com.
Cautionary Note on Forward-Looking Statements
This press release, the interviews 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 (including, without limitation, the results of the Company’s marketing and sales efforts for, and revenue generated from, BUNAVAIL as well as the results of the Company’s clinical trials for, and FDA review of, BEMA Buprenorphine) 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.
Readers are cautioned that peak sales and market size estimates have been determined on the basis of market research and comparable product analysis, but no assurances can be given that such estimates are accurate or that such sales levels will be achieved, if at all.
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. PAINKYLTM is a trademark owned by TTY Biopharm. All other trademarks and tradenames are owned by their respective owners.
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SOURCE BioDelivery Sciences International, Inc.
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