By Staff Reports
(DGIwire) — Chronic lower back pain has become a common complaint. Does this mean we should just resign ourselves to a stiff lower dorsum and keep a stiff upper lip? The answer is no, because when back pain becomes constant, it can lead to serious consequences. Since chronic lower back pain is difficult to diagnose and treat effectively, it lingers—and questions can arise about just how much pain actually exists. This skepticism, in turn, can alter how one interacts with and relates to the world. The main problem is that people can’t see tangible evidence of back pain. Sometimes even x-rays and MRIs can’t identify the problem. Meanwhile, there’s no visible bandage that would give us permission to complain about pain.
In a recent article on LiveScience.com, Rob Froud, Senior Research Fellow at the University of Warwick (UK), outlines how back pain has been historically addressed, and concludes that doctors might not be measuring the most important element. Originally there was a focus on mobility; if a patient could move, he or she was considered clinically healthy even if they were still in pain. Later, doctors worked on decreasing pain and improving function. Currently, Froud says, patients with back pain might be offered advice, the drug acetaminophen, group exercise, manual therapy and acupuncture as possible remedies. The problem with this focus, says Froud, is that it ignores the secondary psychosocial effects of back pain, isolation and depression, which might ultimately be more difficult and expensive to treat than a bad back. Froud concludes that initially taking more time to diagnose the cause and then finding the best way to relieve pain will improve the patient’s quality of life and reduce overall costs.
Fortunately, BioDelivery Sciences International (BDSI), a specialty pharmaceutical company based in Raleigh, NC, is studying in clinical trials what it hopes to be an effective product for managing chronic pain disorders such as lower back pain. In January 2014, BDSI and Endo Pharmaceuticals announced positive top-line results from a pivotal Phase 3 study of BEMA®Buprenorphine in opioid-naïve subjects. Results of a second Phase 3 study, conducted in opioid-experienced patients, were positive. A New Drug Application is anticipated to be submitted to the Food and Drug Administration in late 2014 or early 2015.
The BEMA drug delivery technology uses a small, bio-erodible film that adheres to the inner lining of the cheek within seconds and then efficiently delivers a dose of drug across the mucous membrane. BEMA films completely dissolve inside the mouth within minutes. 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.
Mark A. Sirgo, Pharm.D., President and Chief Executive Officer of BDSI, says “We are working aggressively to complete the Phase 3 program for BEMA Buprenorphine, and believe the market opportunity for an opioid with a lower propensity for abuse and addiction compared to Schedule 2 opioids like oxycontin and morphine, continues to expand.”