The FDA has approved BioDelivery Sciences International Inc abuse resistant opioid treatment for chronic pain.
The story in Reuters Health says that 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 ending March in seven dosages.
Belbuca is placed on the inner lining of the cheek, leading to faster delivery of 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. Since most of the drug is absorbed through the cheek and with little going through the digestive tract, Belbuca could potentially lead to lower constipation, a common side effect that most oral drugs are known to cause.
Given the lower possibilities of misuse as seen with buprenorphine, physicians can write a six-month prescription as opposed to writing one on a strict monthly basis. The abuse of opioids, a class of drugs that include heroin and prescription painkillers, has long been a concern in the United States. An overdose of prescription painkillers can produce euphoric highs and even 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.