New Opioid ‘Film’ Nears FDA Approval

By Pat Anson, Editor

The Food and Drug Administration has accepted a new drug application (NDA) for a new opioid film patch that could give chronic pain patients an alternative to hydrocodone and other painkillers that have become harder to get prescriptions for.

Image courtesy of biodelivery sciences

The buprenorphine film – to be sold under the brand name Belbuca -- was developed by Endo International (NASDAQ: ENDP) and BioDelivery Sciences (NASDAQ: BDSI) for the management of chronic pain requiring daily, long-term opioid treatment. The companies are hoping for final 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.

"NDA acceptance represents an important step forward in our commitment to bringing to patients new therapeutic options for the treatment of chronic pain. We believe that Belbuca is a significant advancement in pain care, and an important extension to Endo's portfolio of products," said Rajiv De Silva, President and CEO of Endo.

Buprenorphine is a Schedule III controlled substance, meaning that it has been designated as having lower abuse potential than Schedule II drugs, a category which includes hydrocodone and most opioid painkillers. Many pain patients are having difficulty getting prescriptions for hydrocodone and other Schedule II drugs filled.

"The FDA's acceptance of our Belbuca NDA is a significant milestone for BDSI and in our partnership with Endo," said Dr. Mark Sirgo, President and CEO of BDSI. "We believe that Belbuca can offer those suffering with chronic pain with a novel treatment approach.”

Belbuca contains one-tenth to one-twentieth the amount of buprenorphine as Suboxone and other products that are used to treat opioid addiction.  Although the dose of buprenorphine is smaller, Sirgo says Belbuca 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 Phase III 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.

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

Buprenorphine is already used to treat pain in transdermal skin patches made by Purdue Pharma under the brand name Butrans.