BEMA Buprenorphine Dental Surgery Pain Treatment Success
This past week, BioDelivery Sciences International Inc. announced the successful completion of phase II trials for its BEMA Buprenorphine dental surgery pain treatment.
The Raleigh-based company has been working to use its BEMA technology for the treatment of pain following third molar extraction dental surgery. BEMA, or BioErodible MucoAdhesive, is a thin, dissolvable film that is applied to the lining of the cheek to deliver pain medication.
In the phase II trial, BDSI compared results of the different doses of BEMA Buprenorphine against a placebo and oral oxycodone. Andrew Finn, executive vice president of product development, said the results were consistent with phase I results and the doses were applicable for the relief of chronic pain. The company will continue to work to determine the effectiveness of BEMA Buprenorhine for acute pain.
“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,” said Mark A. Sirgo, president and CEO. “We are hopeful that this profile, along with our Phase 2 data, will lead to significant partnering interest.”
About BEMA Buprenorphine
BEMA Buprenorphine utilizes BDSI’s proprietary BioErodible MucoAdhesive (BEMA) drug delivery technology, which consists of a small, dissolvable, polymer film for application to the buccal mucosa (inner lining of the cheek) to deliver the opioid analgesic buprenorphine. Buprenorphine is not well absorbed orally, and is available in the U.S. to treat pain only in an injectable formulation known as Buprenex® Injectable. Pharmacokinetic studies have demonstrated the ability of the BEMA technology to deliver concentrations of buprenorphine comparable to concentrations seen with approved IV doses. A BEMA formulation potentially provides an opportunity for buprenorphine to be used in the treatment of various pain conditions in the outpatient setting. Buprenorphine is an attractive option for development given that it has demonstrated efficacy in the treatment of pain and is a Schedule III opioid, meaning there is a lower potential for abuse and addiction compared to Schedule II drugs.
According to data from Wolters Kluwer, the market for opioid analgesics for the treatment of pain totaled nearly $10 billion in 2008. BDSI believes that BEMA Buprenorphine may have the potential to offer advantages over other opioid analgesics making it a desirable partnering opportunity and a strong fit with its first product, ONSOLIS (fentanyl buccal soluble film), which was approved by FDA in July 2009 for management of breakthrough pain in opioid tolerant patients with cancer.
Source: BioDelivery Sciences International Inc.
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