Opioid analgesics play an important role in the management of both acute and chronic pain conditions. Opioids exert their effects by binding to opioid receptors. While some of the effects, such as analgesia are desirable, others such as sedation, nausea, cognitive impairment and constipation, can be troublesome. Since chronic pain necessitates the use of long term treatment, such adverse events can impact quality of life and impede adherence. Additionally, use of long-term therapy can lead to concerns regarding drug abuse, addiction and dependency.
Buprenorphine is a partial mu-opioid receptor agonist and a kappa antagonist, making it unique compared to full mu-opioid agonists such as morphine. It is a potent analgesic with a relatively long duration of action. Buprenorphine is a Schedule III controlled substance meaning that it has lower abuse potential than Schedule II drugs.
In January 2012, BDSI signed a worldwide license and development agreement with Endo Pharmaceuticals for the exclusive rights to develop and commercialize BEMA® Buprenorphine for the treatment of chronic pain.
BEMA® Buprenorphine is currently in Phase 3 clinical development for the treatment of moderate to severe chronic pain. The Phase 3 program for BEMA® Buprenorphine consists of two efficacy studies. Both studies are double-blind, randomized, placebo-controlled, enriched-enrollment studies in patients with chronic lower back pain. BUP-307 will be conducted in opioid experienced subjects, and BUP-308 will be conducted in subjects naïve to opioid therapy. The clinical studies are anticipated to last 12-18 months, with results available in the second half of 2013 or early 2014. Additional information can be found at www.clinicaltrials.gov.