BDSI reports encouraging preliminary results from Phase I pain trial

BioDelivery Sciences International, a specialty pharmaceutical company, has announced preliminary results from a Phase I study assessing two new formulations of the opioid analgesic buprenorphine utilizing the company’s BEMA drug delivery technology.

The study was performed to select the optimal formulation for Phase II clinical development of the product candidate, known as BEMA buprenorphine.

Approximately 14 healthy volunteers participated in this randomized, blinded, cross-over study which compared two formulations of BEMA buprenorphine with intravenous buprenorphine and placebo.

Following administration of both BEMA formulations, buprenorphine plasma concentrations were measureable within 15 minutes and accompanied by changes in pupillometry, a standard measure of opioid pharmacodynamic effect. Notably, this effect was maintained over the eight-hour duration of the study without evidence of significant decline. Local application of the BEMA films in the mouth were well tolerated, the company said.

BioDelivery Sciences International’s (BDSI) initial product candidate utilizing the BEMA drug delivery technology, Onsolis (fentanyl buccal soluble film; formerly BEMA Fentanyl), is currently under review at the FDA for the potential treatment of breakthrough pain in opioid tolerant patients with cancer. The company anticipates an FDA decision on the new drug application for Onsolis during the first half of 2009.

David Blum, vice president of clinical development and medical affairs at BDSI, said: This study demonstrates that the new BEMA formulations provide rapid rise to peak plasma concentrations and high bioavailability, or absorption, of buprenorphine. The time to and extent of the maximum plasma concentrations exceeded our expectations for these formulations compared to the previously tested formulation.