Sufferers of chronic pain due to cancer and other debilitating diseases may have new hope on the horizon with the announcement from BioDelivery Sciences International Inc. that BEMA Buprenorphine has concluded the randomized portion of Phase 3 clinical trials.
The randomized portion of Phase 3 clinical trials is to assess the efficacy and safety of new drugs under the U. S. Food and Drug Administration (FDA) trial protocols for new drugs.
BioDelivery Sciences International Inc. (BDSI) says that it expects to report top line results of the testing of BEMA Buprenorphine in mid to late September of this year. Dr. Andrew Finn, BDSI’s executive vice president of product development, adds that, “Assuming positive study results, we would hope to be in a position to file a New Drug Application (NDA) for this product in the first half of 2012.”
In order for any new drug to receive FDA approval, it has to go through a rigorous and lengthy clinical trial process involving various stages (Phase 1, 2, 3, and 4), after which, if all phases are completed successfully, an NDA can be filed.
What’s so important about BEMA Buprenorphine? According to BDSI, there is a significant and unmet medical need for potent new analgesics for the treatment of chronic pain. Because of BEMA Buprenorphine’s potent analgesic properties, along with its differentiating characteristics from other opioids and its Drug Enforcement Administration (DEA) Schedule III designation (which means there is less addiction potential than Schedule II products such as morphine and oxycodone), BDSI believes buprenorphine is an attractive option for chronic pain treatment.
If BEMA Buprenorphine is approved, it could be the first oral transmucosal form of buprenorphine to treat chronic pain in the U.S.
Opioid analgesic sales in this country are in excess of $10 billion and growing.