BEMA® Buprenorphine
BioDelivery Sciences is developing BEMA® Buprenorphine for the treatment of acute and chronic pain conditions.
Buprenorphine is a partial mu-opiate receptor agonist. It is a potent analgesic with a relatively long duration of action and poor oral bioavailability. An injectable formulation of buprenorphine (Buprenex® Injectable) is currently approved in the U.S. for the treatment of moderate to severe pain. Buprenophine is a Schedule III controlled substance1. In addition, sublingual tablet formulations containing buprenorphine (Subutex® and Suboxone®) are currently approved in the U.S. for the treatment of opioid dependence.
The BEMA® drug delivery system may enable BioDelivery Sciences to provide buprenorphine in a form suitable for ambulatory care. The company believes that BEMA® Buprenorphine could be an important therapeutic alternative for patients with incomplete pain relief or those unable to tolerate the side effects of non-narcotic analgesics (e.g., NSAIDS, COX-2 Inhibitors).
BEMA® Buprenorphine will be developed both for acute pain conditions such as postoperative pain and chronic pain conditions such as low back, osteoarthritis, and neuropathic pain. BDSI submitted an IND for BEMA® Buprenorphine in December 2005. An initial Phase 1 trial for BEMA® Buprenorphine has been completed, and this clinical study showed that the BEMA® delivery system was able to provide buprenorphine plasma concentrations that were in the anticipated target range.
By the end of 2008, the market for pharmaceutical products to relieve pain exceeded $30 billion, with the opioids being the leading class of products. BDSI believes that BEMA® Buprenorphine has the potential to achieve in excess of $500 million in peak annual sales.
1 The U.S. Drug Enforcement Agency defines a Schedule III drug as: (1) Drug or other substance that has a potential for abuse less than the drugs or other substances in Schedules I and II; (2) Drug or other substance that has a currently accepted medical use in treatment in the United States, and (3) Abuse of the drug or other substance may lead to moderate or low physical dependence or high psychological dependence.
| DEA Schedule | Potential for Abuse | Currently Accepted Medical Use in the U.S. | Physical Dependence Potential | Psychological Dependence Potential |
|---|---|---|---|---|
| I | High | None | Severe | Severe |
| II | High | Yes | Severe | Severe |
| III | Low relative to Schedules I and II | Yes | Moderate or low | High |
| IV | Low relative to Schedule III | Yes | Limited relative to Schedule III | Limited relative to Schedule III |
Source:
Adapted from U.S. DEA (Drug Enforcement Administration) 4/accessed April 2008 http://www.justice.gov/dea/pubs/csa/812.htm#c.
Buprenex® is a registered trademark of Reckitt & Colman Ltd. Subutex® and Suboxone® are registered trademarks of Reckitt Benckiser Healthcare Ltd.