By Pat Anson, Editor
A new opioid film designed to be taken orally twice a day significantly reduces pain and the need for breakthrough pain medication in patients with moderate to severe pain, according to a new clinical study by Endo International (NASDAQ: ENDP). The results of the Phase III study were released this weekend at the International Conference on Opioids in Boston.
Belbuca is the only analgesic formulation of buprenorphine in a sublingual film that is dissolved in the mouth and absorbed through the inner lining of the cheek.
Buprenorphine is an opioid classified as a Schedule III controlled substance, which means it has lower abuse potential than Schedule II drugs, a category that includes opioids such as hydrocodone. Buprenorphine is also used to treat addiction when combined with naloxone.
Over 400 patients with moderate to severe pain took Belbuca for 48 weeks after being titrated to find the most effective dose. During long term treatment, the average daily pain score was about 3 on a scale of 0 (no pain) to 10 (worst pain imaginable).
The need for daily rescue medication to relieve breakthrough pain decreased from an average of 3 tablets to 1.1 tablets.
"Many patients living with chronic pain require long-term treatment to control their suffering, so it is important that patients have options to manage their pain," said Martin Hale, MD, Medical Director of Gold Coast Research, one of the study's investigators. "These new findings support the safety and tolerability of treatment with Belbuca across a broad range of dosage strengths.”
About half of the patients (54%) experienced some type of side effect, including nausea, constipation, headache, vomiting and upper respiratory tract infection.
Belbuca was approved by the U.S. Food and Drug Administration in October 2015 for use in patients with pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatments are inadequate.
Belbuca utilizes a drug delivery system developed by BioDelivery Sciences (NASDAQ: BDSI). Because the oral film delivers buprenorphine into the bloodstream faster than pills or skin patches, lower doses are needed to treat pain. The film contains one-tenth to one-twentieth the amount of buprenorphine as Suboxone and other products that are used to treat opioid addiction.
Belbuca is available in seven different dosages, allowing physicians to titrate Belbuca to a tolerable dose that provides pain relief with fewer side effects. According to the Healthcare Bluebook, a 75mcg, 60-day supply of Belbuca should cost about $265.