The phase 3 clinical program will evaluate the efficacy and safety of the experimental drug in treating moderate to severe chronic pain.
A phase 3 clinical program evaluating the efficacy and safety of BEMA Buprenorphine for the treatment of moderate to severe chronic pain enrolled its first patient.
BioDelivery Sciences International, Inc. is coordinating the trial.
“We believe that with our experienced and enthusiastic investigators, we can progress this program expeditiously and have results available by the third quarter of next year Positive findings from this study would then allow for an NDA filing in the first half of 2012.”
“Enrollment of the first patient into the BEMA Buprenorphine Phase 3 program marks our continued progress in making this novel treatment available for patients with moderate to severe chronic pain,” said Dr. Andrew Finn, executive vice president of Product Development at BDSI, in a press release. “We believe that with our experienced and enthusiastic investigators, we can progress this program expeditiously and have results available by the third quarter of next year. Positive findings from this study would then allow for an NDA filing in the first half of 2012.”
According to Dr. Mark A. Sirgo, president and chief executive officer of BDSI, “BEMA Buprenorphine could play an important future role in the treatment of chronic pain and may offer distinct advantages over other marketed opioid analgesics including oxycodone, hydrocodone, and morphine. These advantages would in part come from the fact that we anticipate it being classified as a Schedule III product, meaning there is a potential for less abuse than Schedule II products. With overall sales of opioid analgesics in the U.S. approaching nearly $10 billion, we believe this represents a significant opportunity for BDSI.”
BEMA Buprenorphine utilizes BDSI’s proprietary BioErodible MucoAdhesive (BEMA) drug-delivery technology. This technology consists of a small, dissolvable, polymer film for application to the buccal mucosa to deliver the opioid analgesic buprenorphine.
According to the website for BEMA Buprenorphine, the drug is a “partial mu-opiate receptor agonist. It is a potent analgesic with a relatively long duration of action and poor oral bioavailability.”
“Buprenophine is a Schedule III controlled substance. In addition, sublingual tablet formulations containing buprenorphine (Subutex and Suboxone) are currently approved in the U.S. for the treatment of opioid dependence.”
The devolopers are seeking approval for the treatment of “acute pain conditions such as postoperative pain and chronic pain conditions such as low back, osteoarthritis, and neuropathic pain.” So far, “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.”
BioDelivery Sciences International is a specialty pharmaceutical company that focuses on developing patented drug delivery technologies. Currently, BDSI’s pain franchise includes ONSOLIS (fentanyl buccal soluble film) for the management of breakthrough pain in opioid tolerant, adult patients with cancer. BEMA Buprenorphine, is being developed for the treatment of moderate to severe chronic pain and is in development in a high dose formulation for the treatment of opioid dependence. Additional product candidates are being developed utilizing the BEMA technology for conditions such as nausea/vomiting (BEMA Granisetron) and migraine (BEMA “Triptan”).
Source: BioDelivery Sciences International
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