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.
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.
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.