GlobeNewswire Inc | Sep 11, 2020 08:00AM EDT

September 11, 2020

RALEIGH, N.C., Sept. 11, 2020 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc.(NASDAQ: BDSI), a rapidly growing specialty pharmaceutical company dedicated to patients living with chronic conditions, today announced the presentation of five scientific posters highlighting data regarding BELBUCA at the 14th Annual PAINWeek 2020 National Conference on Pain Management taking place virtually September 11-13, 2020.

Poster Presentations:

-- A Phase I Placebo-Controlled Trial Comparing the Effect of Buprenorphine Buccal Film and Oral Oxycodone Hydrochloride: PupillometryAuthors: Lynn Webster, MD; Jacqueline Cater, PhD; Thomas Smith, MD

-- Secondary Outcomes of a Phase I Placebo-Controlled Trial Comparing the Effect of Buprenorphine Buccal Film and Oral Oxycodone Hydrochloride on Respiratory DriveAuthors: Lynn Webster, MD; Jacqueline Cater, PhD; Thomas Smith, MD

-- Key Outcomes of a Phase I Placebo-Controlled Trial Comparing the Effect of Buprenorphine Buccal Film and Oral Oxycodone Hydrochloride on Respiratory DriveAuthors: Lynn Webster, MD; Jacqueline Cater, PhD; Thomas Smith, MD

-- The Pharmacodynamics and Pharmacokinetics of Buprenorphine Buccal Film Versus Oral Oxycodone Hydrochloride: Results of a Phase I Placebo-Controlled TrialAuthors: Lynn Webster, MD; Jacqueline Cater, PhD; Thomas Smith, MD

-- Buprenorphine Buccal Film in Patients with Chronic Low Back Pain: A Pooled Subgroup Analysis of Two Double-Blind, Placebo-Controlled, Randomized Withdrawal Trials by Baseline Pain SeverityAuthors: Christine Moore, PhD; P. Hunter Allman, PhD; Gary Cutter, PhD

We are very pleased to have this data being presented this year at PAINWeek 2020, the largest pain conference in the US, said Thomas Smith, MD, Chief Medical Officer of BDSI. This new information adds to the growing awareness and appreciation of BELBUCA as an important treatment option for patients suffering from chronic pain.

All five posters will be available for public viewing by visiting thePAINWeek Conference website following the conclusion of the Conference.

Important Safety Information About BELBUCA

BELBUCA (buprenorphine buccal film), CIII is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Limitations of Use

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with long-acting opioid formulations, reserve BELBUCA for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

BELBUCAis not indicated as an as-needed (prn) analgesic.

WARNING: ADDICTION, ABUSE,ANDMISUSE; RISK EVALUATION AND MITIGATION STRATEGY(REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATALOPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINESAND OTHER CNS DEPRESSANTS

Addiction, Abuse, and MisuseBELBUCA^exposes patients and other users to the risks of opioid addiction,abuse, and misuse, which can lead to overdose and death. Assess patient?s riskprior to prescribing BELBUCA^ and monitor patients regularly for thesebehaviors and conditions.

Risk Evaluation and Mitigation Strategy (REMS)To ensure that the benefits of opioid analgesics outweigh the risks ofaddiction, abuse, and misuse, the FDA has required a REMS for these products.Under the requirements of the REMS, drug companies with approved opioidanalgesic products must make REMS-compliant education programs available tohealthcare providers. Healthcare providers are strongly encouraged to

* complete a REMS-compliant education program, * counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, * emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and * consider other tools to improve patient, household, and community safety.

Life-Threatening Respiratory DepressionSerious, life-threatening, or fatal respiratory depression may occur with useof BELBUCA^. Monitor for respiratory depression, especially during initiationof BELBUCA^ or following a dose increase.

Accidental ExposureAccidental exposure to even one dose of BELBUCA^, especially by children, canresult in a fatal overdose of buprenorphine.

Neonatal Opioid Withdrawal SyndromeProlonged use of BELBUCA^during pregnancy can result in neonatal opioidwithdrawal syndrome, which may be life-threatening if not recognized andtreated, and requires management according to protocols developed byneonatology experts. If opioid use is required for a prolonged period in apregnant woman, advise the patient of the risk of neonatal opioid withdrawalsyndrome and ensure that appropriate treatment will be available.

Risks from Concomitant Use with Benzodiazepines or Other CNS DepressantsConcomitant use of opioids with benzodiazepines or other central nervous system(CNS) depressants, including alcohol, may result in profound sedation,respiratory depression, coma, and death. Reserve concomitant prescribing foruse in patients for whom alternative treatment options are inadequate; limitdosages and durations to the minimum required; and follow patients for signsand symptoms of respiratory depression and sedation.

BELBUCAis contraindicated in patients with significant respiratory depression; acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment; known or suspected gastrointestinal obstruction, including paralytic ileus; and hypersensitivity (e.g., anaphylaxis) to buprenorphine.

BELBUCA contains buprenorphine, a Schedule III controlled substance. As an opioid, BELBUCA exposes users to the risks of addiction, abuse, and misuse. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed BELBUCA and in those who obtain the drug illicitly. Addiction can occur at recommended doses and if the drug is misused or abused.

Potential serious adverse events caused by opioids include addiction, abuse, and misuse; life-threatening respiratory depression; neonatal opioid withdrawal syndrome; risks due to interactions with benzodiazepines or other central nervous system depressants; risk of life-threatening respiratory depression in patients with chronic pulmonary disease or in elderly, cachectic, or debilitated patients; adrenal insufficiency; QTc prolongation; severe hypotension; risks of use in patients with increased intracranial pressure, brain tumors, head injury, or impaired consciousness; hepatotoxicity; risk of overdose in patients with moderate or severe hepatic impairment; anaphylactic/allergic reactions; risk of use in patients with gastrointestinal conditions; increased risk of seizures in patients with seizure disorders; risks of use in cancer patients with oral mucositis; risks of driving and operating machinery.

The most common adverse reactions (5%) reported by patients treated with BELBUCA in the clinical trials were nausea, constipation, headache, vomiting, fatigue, dizziness, somnolence, diarrhea, dry mouth, and upper respiratory tract infection.

For full Prescribing Information, including Boxed Warning, visit www.belbuca.com.

To report SUSPECTED ADVERSE REACTIONS, contact BioDelivery Sciences International, Inc. at 1-800-469-0261 or FDA at 1-800-FDA-1088 or www.fda.gov/safety/medwatch.

ABOUTBIODELIVERY SCIENCES INTERNATIONAL, INC.

BioDelivery Sciences International, Inc. (NASDAQ: BDSI) is a commercial-stage specialty pharmaceutical company dedicated to patients living with chronic conditions. BDSI has built a portfolio of products that includes utilizing its novel and proprietary BioErodible MucoAdhesive (BEMA) technology 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 marketed products address serious and debilitating conditions, including chronic pain and opioid-induced constipation.

2020BioDelivery Sciences International, Inc. All rights reserved.

Contact:

Terry CoelhoChief Financial OfficerBDSI_IR@bdsi.com

Bob YedidLifeSci Advisors(646) 597-6989bob@lifesciadvisors.com