BDSI's BEMA Buprenorphine Phase 2 study meets primary efficacy endpoint

Dec 17 2009

BioDelivery Sciences International, Inc. (Nasdaq:BDSI) announced that the primary efficacy endpoint was achieved in the Company’s Phase 2 pain study assessing the efficacy and safety of BEMA Buprenorphine. The positive results follow BDSI’s March 2009 announcement of favorable Phase 1 study results.

The Phase 2 clinical trial was a double-blind, randomized, placebo-controlled study of BEMA Buprenorphine for the treatment of pain following third molar extraction (dental surgery), a common study used to assess the efficacy of potential products to treat pain. Subjects received one of the following treatments: BEMA Buprenorphine, oral 5mg oxycodone, or placebo. BEMA Buprenorphine treatments included a dose of 0.25 mg and two different BEMA formulations of a 0.5 mg dose. One of the 0.5 mg BEMA formulations, evaluated in the previous Phase 1 study, was designed for faster and greater absorption than the other. The primary study endpoint used to evaluate the analgesic effect was the sum of pain intensity differences over the 8 hour post-dose period (SPID-8).

The BEMA Buprenorphine 0.5 mg formulation with the faster rate and extent of absorption demonstrated a statistically greater improvement than placebo in the primary efficacy endpoint, SPID-8 (baseline observation carry forward analysis). The other two doses did not achieve significance, although they were numerically superior. The incidence of adverse events was comparable to that expected for an opioid analgesic in a study of this nature. The results also showed that oxycodone was not significantly different from placebo on SPID-8. Analyses of secondary outcome measures, adverse events, and plasma drug concentrations are in process.

“The results to date are consistent with our previous Phase 1 clinical experience and indicate a dose response in pain relief that may be particularly applicable to chronic pain,” stated Dr. Andrew Finn, Executive Vice President of Product Development at BDSI. “The remaining analysis will allow us to make the same determination about the effectiveness of BEMA Buprenorphine for acute pain.”

“With this data we now have a second potential analgesic product to join ONSOLIS (fentanyl buccal soluble film) which launched in October of this year,” stated Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI. “We believe that BEMA Buprenorphine has the potential to become a major player in the treatment of pain by addressing a significant unmet market need by virtue of a lower propensity for abuse and addiction compared to other opioids such as oxycodone and morphine. We are hopeful that this profile, along with our Phase 2 data, will lead to significant partnering interest.”