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BioDelivery Sciences Gets FDA Approval for New Opioid Pain and Addiction Treatment Cheek Patches
BioDelivery Sciences International has received FDA approval recently for two opioid medications that use the company’s proprietary drug-delivery technology – a thin, dissolvable film placed on the inside of the cheek.
In a move that seems more than a little ironic, one of the new products, Belbuca, is addictive, while the other, Bunavail, is an addiction treatment drug combination.
Belbuca delivers the painkiller buprenorphine, an addictive opioid which is increasingly abused or diverted by opioid addicts in treatment, who sell or trade it for heroin.
Bunavail, the company’s other new drug, contains buprenorphine and naloxone together, which is a common treatment for opioid addiction.
Both drugs use the company’s proprietary transmucosal delivery system, a small patch placed on the mucosa of the inner cheek, or buccal area of the mouth. The delivery system technology is called BEMA (BioErodible MucoAdhesive) and was developed by BioDelivery Sciences. The word buccal, which refers to the oral tissue inside the cheek, apparently inspired the names of the drugs, which both incorporate part of the word.
Similar to, but not the same as Suboxone
Bunavail is similar to the existing addiction treatment drug Suboxone, also a buprenorphine and naloxone mix. Developed by Reckitt Benckiser and now sold by Indivior, Suboxone is provided as a dissolvable patch that is placed under the tongue rather than inside the cheek.
It’s no surprise that BioDelivery wants a piece of the expanding opioid addiction treatment market. Suboxone sales of more than $1 billion in 2014 makes it the market leader for opioid addiction treatment drugs. And with such treatment seen to be increasing, the opioid addiction treatment market appears primed for another player.
Buprenorphine is said to have “a lower abuse potential than most opioid medications,” a claim that helped influence the FDA’s approval of the Belbuca cheek patch. BioDelivery says its film patch chemistry helps prevent abuse via injecting or snorting because the patch is “difficult to crush or liquefy.”
Because of the lower possibilities of misuse often stated for buprenorphine, physicians are allowed to write a six-month prescription, compared to the usual monthly basis or less.
The FDA approval of Belbuca was “to manage chronic pain that doesn’t respond to other pain drugs and is severe enough to require daily, all-day treatment.”
Buprenorphine is an addiction risk
But as an opioid, buprenorphine is always an addiction risk. As with the label on other prescription opioids, doctors are warned to assess a patient’s risk for abuse and to follow their use. Because opioids can slow breathing to dangerously low and fatal levels, the label adds that these risks are greatest when starting the drug or after a dose increase.
These risks and warnings are common to all prescription opioid / opiate medications. Yet as we have seen, addiction has been skyrocketing for a decade, and the major cause has been laid at the feet of irresponsible over-prescribing, under-monitoring physicians, as well as a drug industry that misled doctors and the public about the relative safety of their painkillers.
The FDA approved the Suboxone-like Bunavail over a year ago. While it’s been getting finances and other things in place for a launch, Indivior’s Suboxone market share slipped from 67 percent in 2013 to 58 percent in 2014, due to competition from at least two FDA-approved generic suboxone/naloxone tablets that are also dissolved under the tongue. While the under-tongue products notoriously taste unpleasant, BioDelivery’s cheek-patch Bunavail not only dissolves more quickly but tastes a lot better, the company says.
Patients taking morphine or oxycodone for pain “can be safely switched to buprenorphine buccal film without the need for tapering and without causing significant withdrawal or under-treatment of their pain,” according to a new randomized trial testing BioDelivery’s in-cheek delivery system. Another study showed that a buccal film patch increases the bioavailability of buprenorphine well above the usual oral absorption rate. And another study showed that buprenorphine delivered through a buccal film “can relieve chronic low back pain with few adverse effects.”
Will expanded buprenorphine treatments mean more abuse?
The positive features of the new buccal buprenorphine painkiller may bode well for patients and attending physicians, provided they prescribe responsibly.
But if history has taught us anything, we in the addiction treatment industry may be looking at more patients needing treatment for buprenorphine abuse and addiction – and more drug reps arriving at our offices with slick pamphlets and samples of the latest buccal drug addiction treatment patches.
At Novus, we are leaders in the medical detoxification of opioid dependent patients, preparing them for a successful rehabilitation on their journey to get their lives back. We do employ whatever drugs are medically necessary to ensure the comfort, safety and effectiveness of the detoxification. But our patients leave drug-free. And we encourage them to seek a life free from all addictive substances.
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