BioDelivery Sciences Announces Phase I Clinical Trial Results at the American Academy of Pain Medicine’s 36th Annual Meeting – GuruFocus.com

Effect of Each Drug Treatment on Respiratory Drive as Measured by Minute Ventilation LS Mean Difference from Placebo at Emax

Effect of Each Drug Treatment on Respiratory Drive as Measured by Minute Ventilation LS Mean Difference from Placebo at Emax

BELBUCA Effect on Respiratory Drive was Comparable to Placebo in Clinical Trial at all Tested Doses

Immediate Release Oral Oxycodone HCl Associated with a Dose-Dependent Decrease in Respiratory Drive Compared to Placebo

RALEIGH, N.C., Feb. 27, 2020 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI), a rapidly growing specialty pharmaceutical company dedicated to patients living with serious and complex chronic conditions, today presented at the American Academy of Pain Medicines (AAPM) 36th Annual Meeting the results of a study titled, A Phase I Placebo-Controlled Trial Comparing the Effect of Buprenorphine Buccal Film and Oral Oxycodone Hydrochloride on Respiratory Drive.

In May 2019, in response to significant challenges chronic pain patients face in obtaining adequate care and the ongoing opioid crisis, The Pain Management Best Practices Inter-Agency Task Force report recommended more research activities directed to better understanding the use of buprenorphine, a Schedule III opioid. Opioids can cause serious, life-threatening, or fatal respiratory depression. Respiratory depression is a breathing disorder characterized by slow and ineffective breathing and is the leading cause of opioid related deaths. In this clinical trial, BDSI evaluated the effect of BELBUCA (buprenorphine buccal film), a Schedule III opioid, and oral oxycodone HCI, a Schedule II opioid, on respiratory drive.

Study Design: Study subjects (N = 19) were healthy males and females self-identifying as recreational drug users and determined via naloxone challenge to not be physically dependent on opioids.

Effect on respiratory drive was assessed using a double-blind, double-dummy, 6-treatment, 6-period, placebo controlled, randomized crossover design.

Treatments studied included single doses of: BELBUCA (300 mcg, 600 mcg, and 900 mcg); oral oxycodone hydrochloride (Oxy 30 mg and 60 mg); and placebo (each separated by a 7-day washout period).

Respiratory drive was evaluated by measuring the ventilatory response to hypercapnia (excess carbon dioxide in the bloodstream) through assessment of the maximum change in minute ventilation (Emax), which is the maximum amount inhaled or exhaled in one minute, after administration of each study drug. Statistical analyses were performed using a linear mixed-effects model.

Results: The least square mean differences in Emax versus placebo were as follows: Oxy 30 mg (828.5, P=0.668); Oxy 60 mg (5188.6, P=0.008); BELBUCA 300 mcg (+1206.9, P=0.533); BELBUCA 600 mcg (+245.4, P=0.896); and BELBUCA 900 mcg (+1473.3, P=0.440).

A chart/graphic accompanying this announcement is available at:https://www.globenewswire.com/NewsRoom/AttachmentNg/d148dcf8-f359-4b36-ada6-dd34da39f6e6

Conclusion: BELBUCA effect on respiratory drive was comparable to placebo at all doses tested.

The effect of immediate release oral oxycodone HCl resulted in a dose-dependent decrease in respiratory drive compared to placebo.

This is an important and novel study that shows the comparative effects of buprenorphine buccal film and oral oxycodone on respiratory drive, stated Lynn Webster, M.D., the principal investigator of the study. Thomas Smith, M.D., Chief Medical Officer at BDSI, added, Consistent with the Task Forces recommendation, BDSI is providing the medical community with the results of this safety study to help providers make informed treatment decisions. This study provides additional scientific support for the use of BELBUCA as a primary treatment option 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.

Serious, life-threatening, or fatal respiratory depression may occur with use of BELBUCA. BELBUCA is 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.

Please see important safety information about BELBUCA below.

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

The Pain Management Best Practices Inter-Agency Task Force report is available for viewing online at https://www.hhs.gov/ash/advisory-committees/pain/index.html.

IMPORTANT SAFETY INFORMATION ABOUT BELBUCA

INDICATIONBELBUCA (buprenorphine buccal film) 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

IMPORTANT SAFETY INFORMATION about BELBUCA

Addiction, Abuse, and Misuse

BELBUCA exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patients risk prior to prescribing BELBUCA, and monitor regularly for these behaviors and conditions.

Risk Evaluation and Mitigation Strategy (REMS)

To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the FDA has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to

Serious, life-threatening, or fatal respiratory depression may occur with use of BELBUCA. Monitor for respiratory depression, especially during initiation of BELBUCA or following a dose increase. Misuse or abuse of BELBUCA by chewing, swallowing, snorting, or injecting buprenorphine extracted from the buccal film will result in the uncontrolled delivery of buprenorphine and poses a significant risk of overdose and death.

Accidental Exposure

Accidental exposure to even one dose of BELBUCA, especially in children, can result in a fatal overdose of buprenorphine.

Neonatal Opioid Withdrawal Syndrome

Prolonged use of BELBUCA during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

Risks from Concomitant Use with Benzodiazepines Or Other CNS Depressants

Concomitant 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 for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation.

CONTRAINDICATIONS

BELBUCA is 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.

WARNINGS AND PRECAUTIONS

Addiction, Abuse, and Misuse

Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)

Life-Threatening Respiratory Depression

Neonatal Opioid Withdrawal Syndrome

Risks due to Interactions with Benzodiazepines or Other Central Nervous System Depressants

If the decision is made to prescribe a benzodiazepine or other CNS depressant concomitantly with an opioid analgesic, prescribe the lowest effective dosages and minimum durations of concomitant use. Follow patients closely for signs and symptoms of respiratory depression and sedation.

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

Withdrawal

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

ADVERSE REACTIONS

Please see full Prescribing Information, including Boxed Warning and Medication Guide, for BELBUCA.

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

Intended for healthcare professionals of the United States of America only.

About BioDelivery 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, opioid dependence, and opioid-induced constipation.

Cautionary Note on Forward-Looking StatementsThis press release and any statements of employees, representatives, and partners of BDSI 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 BDSIs 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 BDSIs management and are subject to significant risks and uncertainties, including those detailed in the BDSIs filings with the Securities and Exchange Commission. Actual results may differ materially from those set forth or implied 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 BDSIs control) including those set forth in our 2018 annual report on Form 10-K filed with the US Securities and Exchange Commission and subsequent filings. BDSI 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.

2020 BioDelivery Sciences International, Inc. All rights reserved.

Contact:Tirth T. PatelDirector of Investor Relations[emailprotected](919) 582-0294

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BioDelivery Sciences Announces Phase I Clinical Trial Results at the American Academy of Pain Medicine's 36th Annual Meeting - GuruFocus.com