As physicians continue to look for less potent alternatives to prescribing opioid full agonist (morphine or oxycodone) to chronic pain patients, news at PAIN Week 2105 about an investigational drug had people taking notice.
Endo Pharmaceutical (ENDP) and BioDelivery Sciences International (BDSI) presented data for the investigational drug buprenorphine HCI buccal film utilizing BDSI’s BEMA® drug delivery technology.
People involved with the study thinks the results could have important implications for future strategies to broaden treatment options for patients with living with pain who require around-the-clock treatment.
“This study demonstrated that study participants on a full agonist were successfully switched to this opioid partial agonist at approximately 50 percent of the full dose, without the need for an opioid taper and without increasing the risk of withdrawal or loss of pain control,” according to Lynn Webster, M.D., Vice President of Scientific Affairs , PRA Health Sciences. Dr. Webster is the lead study investigator.
The new technology is currently under review by the U.S. Food and Drug Administration (FDA). A decision may be coming soon, the PDUFA action date is in October, 2015.
Dr. Webster, who is a former President of the American Academy of Pain Medicine thinks this is a potentially important development, especially for people with mild to moderate chronic pain.
Speaking from Budapest, Hungary, Dr. Webster said that industry needs to develop safer and more effective alternatives to treating pain.
“I’ve been making that case for five year now,” he told the National Pain Report. “This looks like a potentially effective analgesic for a large portion of our chronic pain population.”
Endo and BDSI will also present their findings later this month at the 26th Annual Meeting of the American Academy of Pain Management in National Harbor, Md.
“Buprenorphine HCl buccal film represents a novel approach to treating chronic pain and if approved, it will be the first and only pain medicine combining the proven efficacy and safety of buprenorphine with BDSI’s unique BEMA® delivery system,” said Andrew Finn , Pharm.D., Executive Vice President of Product Development for BDSI. “We believe that buprenorphine HCl buccal film would be an important new therapy for chronic pain, a serious and debilitating condition that may significantly burden the lives of millions of patients.”