BioDelivery Sciences International Inc recently announced that the U.S. Food and Drug Administration had approved its opioid treatment for chronic pain. Belbuca is an opioid film patch and aims to treat patients with chronic pain who need round-the-clock treatment and for whom current alternatives do not suffice. The patch is expected to be commercially available in the United States by the first quarter of 2016 in seven dosages, according to BioDelivery.
Belbuca is placed on the inner lining of the cheek, leading to faster delivery of the analgesic drug buprenorphine directly into the blood stream. Buprenorphine has a lower abuse potential than most opioid medications. The Belbuca treatment can also prevent misuse through snorting or injecting as the film patch is difficult to crush or liquefy. The lower possibilities of misuse with buprenorphine means that physicians can write a six-month prescription as opposed to writing one on a strict monthly basis.
The abuse of opioids has long been a concern in the United States. An overdose of prescription painkillers can disrupt parts of the brain that control breathing. The approval comes a little more than a month after the FDA staff flagged dosage concerns over Collegium Pharmaceutical Inc’s opioid drug, Xtampza, and Purdue Pharma’s fast-acting oxycodone painkiller.
Since most of the drug is absorbed through the cheek and with little going through the digestive tract, Belbuca could potentially lead to lower instances of constipation, a common side effect that most oral drugs are known to cause.
The approval comes a little more than a month after the FDA staff flagged dosage concerns over Collegium Pharmaceutical Inc’s opioid drug, Xtampza, and Purdue Pharma’s fast-acting oxycodone painkiller.