A Smart Solution for Pain Sufferers May Be on the Horizon

Woman with pills

(DGIwire) — Toxic relationships, with another person or an addictive substance, can be hard to escape. Blame it on the brain: according to neuroscientists at Harvard University Medical School, the brain registers all pleasures in the same way, whether they originate from a psychoactive drug, a monetary reward, a sexual encounter or even a satisfying meal. Pleasure has a distinct signature: the release of the neurotransmitter dopamine in the nucleus accumbens, a cluster of nerve cells lying underneath the cerebral cortex. Dopamine release is so consistently tied with pleasure that this region is known as the brain’s pleasure center.

However, this natural process can quickly turn toxic when the brain’s main source of pleasure is derived from painkillers—whether in the form of illicit drugs such as heroin, or prescription drugs like oxycodone and morphine. Sadly, many people become addicted to painkillers that have been prescribed to them to manage chronic pain disorders such as back pain, neuropathic pain, and pain associated with cancer. Adding to the complexity, opioid dependence is a significantly undertreated condition in the U.S., with nearly two million people dependent on prescription opioids, according to the 2010 National Survey on Drug Use and Health conducted by the U.S. Department of Health and Human Services.

Fortunately, BioDelivery Sciences International, Inc. (BDSI), a specialty pharmaceutical company based in Raleigh, NC, in partnership with Endo Pharmaceuticals, is dedicated to finding methods to manage chronic pain disorders with a lower propensity for addiction and abuse compared to Schedule II opioids such as oxycodone and morphine.

One of these therapies currently in Phase 3 clinical trials is BEMA® Buprenorphine, a potent analgesic with a relatively long duration of action. In January, BDSI announced positive results from the first of two Phase 3 trials in patients with chronic pain. The trial, in patients naïve to opioids, successfully met its primary goal, demonstrating significant improvement in chronic pain compared to placebo. Results from the second Phase 3 pivotal efficacy trial in opioid-experienced patients are expected in early July 2014. If this is successful, the company along with its partner could be submitting these data to the FDA for approval by early 2015.

The BEMA drug delivery technology consists of a small, dissolvable film that is applied to the inner lining of the cheek. BEMA films were designed to rapidly deliver a dose of drug across the mucous membranes or to facilitate administration of drugs with poor oral absorption. BEMA films adhere to oral mucosa in less than five seconds and completely dissolve—making it a fast, and potentially effective way to combat chronic pain. The BEMA technology has been utilized by BDSI to allow the delivery of buprenorphine, a novel type of opioid that—based on its pharmacology—has a lower propensity for abuse and addiction compared to other opioids.

“These are areas where we believe our drug delivery technologies and products can best be applied to address critical unmet medical needs,” said Mark A. Sirgo, President and CEO of BDSI. “We look to improve upon existing drugs by enhancing their efficacy and ease of administration, or create new therapies, all with the ultimate goal of enhancing patient care. We believe that together with our partner, Endo Pharmaceuticals, we can make available to the millions of people in need, new and effective ways to manage their chronic pain.”

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