New Opioid ‘Film’ Could Be Alternative to Hydrocodone

New Opioid ‘Film’ Could Be Alternative to Hydrocodone

A new formulation of an old medication could give chronic pain patients an alternative to hydrocodone and other painkillers that have become harder to get prescriptions for.

Endo International (NASDAQ: ENDP) and BioDelivery Sciences (NASDAQ: BDSI) have submitted a new drug application for a buprenorphine film patch to the Food and Drug Administration for the management of chronic pain requiring daily, long-term opioid treatment. The companies are hoping for FDA approval by October, 2015.

Buprenorphine is an opioid that has long been used as an addiction treatment drug sold under the brand name Suboxone, but it can also be used to treat chronic pain.

““This product has one-tenth to one-twentieth the amount of buprenorphine in products that are used to treat opioid addiction. A much smaller dose of buprenorphine is needed to treat chronic pain in people who are not addicted,” said Dr. Mark Sirgo, President and Chief Executive Officer of BioDelivery Sciences.

Image courtesy of BioDelivery Sciences International

Image courtesy of BioDelivery Sciences International

Although the dose is smaller, Sirgo says the buprenorphine film is effective in treating pain because the drug is absorbed through the inside lining of the cheek and enters the blood stream faster. In a clinical study, he said the film was effective in treating patients who were taking a “hefty dose” of opioids equivalent to 160 mgs of morphine a day.

“We took those patients into one of our Phase III trials, which were enormously successful and positive. We had patients who were on very high doses of opioids and switched them over to buprenorphine and maintained their pain control,” Sirgo told National Pain Report.

Unlike hydrocodone, which was recently reclassified by the DEA as a Schedule II medication, buprenorphine is a Schedule III drug – making it easier to obtain prescriptions for.

Hydrocodone combination products such as Vicodin were reclassified in an effort to combat a nationwide “epidemic” of prescription drug abuse. The rescheduling limits patients to an initial 90-day supply and requires them to see a doctor for a new prescription each time they need a refill. Many pain patients say their doctors are now reluctant to prescribe hydrocodone and pharmacists are unwilling to fill their prescriptions.

“Buprenorphine on a relative basis is as potent as C-II (Schedule II) opioids, it just has a lower side effect liability,” said Sirgo. “We certainly think a lot of physicians who are accustomed to writing a Schedule III hydrocodone combination product will find this extremely attractive. We also hope they will realize this is a less abuse-able and less addicting product.”

Buprenorphine film is less likely to be abused, according to Sirgo, because the patches are difficult to grind or liquefy for snorting or injecting.

“I’m not ruling it out by any means because these addicts will figure out a way, but it’s much more difficult to try to abuse this given the dosage form,” he said.

BioDelivery Sciences recently began marketing a buprenorphine film called Bunavail to treat opioid addiction.

Buprenorphine is already used to treat pain in the form of a transdermal (skin) patches made by Purdue Pharma under the brand name Butrans. Sirgo says the 7-day patches are “a very ineffective way to deliver the drug” and many patients find them inconvenient to wear for a week.


Authored by: Pat Anson, Editor

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Kurt W.G. Matthies

Sublingual or buccal application of opioid medication is not a new idea. The fentanyl “lollipop” Actiq has been treating breakthrough pain for over 10 years. The Fentora tablet, recently approved for the breakthrough pain of cancer, is loaded with a fast dissolving dose of fentanyl that is absorbed by the buccal mucosa, delivering a quickly assimilated dose of the opioid. Both these products have provided relief for thousands of pain sufferers.

Buprenorphine is a partial opioid agonist used primarily for opioid dependence and addiction. While the data is limited, there is one research paper that measures patient reported outcomes using a sublingual delivery system.

In this study published in this months’ Pain Medicine (Pain Med. 2014 Dec;15(12):2087-94. doi: 10.1111/pme.12520. Epub 2014 Sep 12.), thirty-five chronic pain patients (age 24-66) previously treated with high-dose opioid-agonist drugs were converted to SL buphrenorphine.

After two months of this therapy, average pain scores decreased from 7.2 to 3.5, and quality of life scores increased from 6.1 to 7.1 for 35 patients.

If sublingual buphrenorphine is this effective against chronic pain, these results are astonishing. However, given the small sample size of the study, and limited medical information available regarding the study group, I think we should look at these results with some skepticism.

Until we know about the long-term effects of buprenorphine use against chronic pain, I’ll remain reluctant to trade morphine and other full agonists for this partial agonist.

In the mean time, this new product offers exciting possibilities. I’d like to see slow-release buccal delivery formulations developed to deliver available full opioid agonists. If we can achieve a more effective analgesia with lower morphine equivalent doses, this could be a paradigm changing development in the treatment of intractable chronic pain.