BioDelivery Likes Test Results
BioDelivery Sciences International, a Raleigh firm developing new forms of oral drug-delivery systems, is looking forward to some major good news by midyear.
The firm said preliminary results are looking positive from a 14-person Phase 1 study assessing two formulations of a new painkiller technology for delivering the opioid analgesic buprenorphine via the company's proprietary BEMA drug delivery system.
The study was performed to select the optimal formulation for Phase II clinical development of the product candidate, known as BEMA Buprenorphine. The Phase II study is expected to begin by the end of June and, if all goes well, the product candidate could hit Phase III during the first half of next year.
Meanwhile, BioDelivery is awaiting final approval by the U.S. Food and Drug Administration to market its experimental lead product, BEMA Fentanyl, another mouth patch, designed to ease severe pain in cancer patients. The FDA is expected to act on that application by the end of June. If approved, it would trigger a much-anticipated $30 million cash influx from the drug, to be marketed in the United States under the trade name ONSOLIS.