BioDelivery Sciences calls for new treatment options for opioid addiction

As the rate of opioid abuse soars to new levels, growing recognition of the problem is garnering unprecedented media attention—as well as motivating innovative new approaches to better treatment.

For example, generic Vicodin (hydrocodone acetaminophen) ranked as the drug most widely prescribed to Medicare beneficiaries in 2013, according to a new article in The Wall Street Journal. This illustrates how comfortable many doctors have become reaching for this powerful painkiller for primary care, despite its potential for abuse. An analysis of Medicare data found that more than half of the prescriptions came from family-practice or internal-medicine physicians. Researchers said the findings reflect the years-long increase in the use of opioid painkillers in the U.S., which comes in tandem with concerns about abuse, the Journal said. According to the U.S. Centers for Disease Control and Prevention, nearly two million Americans either abused or were dependent on opioids in 2013. About 691,000 providers prescribed the painkiller in 2013 to more than eight million Medicare beneficiaries, according to the Journal.

Meanwhile, when it comes to treating opioid addiction effectively, doctors must focus not only on treating the body but providing behavioral support as well. That was one key message presented to a Congressional subcommittee recently by a range of medical experts, including Nora Volkow, MD, director of the National Institute on Drug Abuse, and Michael Botticelli, director of the Office of National Control Policy The hearing witnesses generally agreed that medication such as buprenorphine combined with behavioral support has been shown to be the most effective treatment for substance use disorders including opioid addiction. Yet despite the strong evidence, less than 40 percent of those receiving treatment for opioid addiction get treated with these medications.

Dr. Mark Sirgo, president and CEO of BioDelivery Sciences, sees these stark realities as a call to action for innovation in the treatment of pain and opioid abuse as well as treating the minds of patients along with their bodies.

BioDelivery Sciences has already taken some promising steps in these directions. For example, in tandem with Endo Pharmaceuticals, the company has overseen the development of BELBUCA. Currently under review at FDA for the treatment of moderate to severe chronic pain, BELBUCA contains buprenorphine, a partial mu-opioid receptor agonist and a kappa antagonist, making it unique compared to full mu-opioid agonist. It is a potent analgesic with a relatively long duration of action. Buprenorphine is a Schedule III controlled substance, meaning that it has lower abuse potential than Schedule II drugs. In January 2014, BDSI and Endo announced positive top-line results from the pivotal Phase 3 efficacy study in opioid naïve subjects. The trial successfully met its primary efficacy endpoint demonstrating significantly improved chronic pain relief compared to placebo. In July 2014, positive topline results were reported from the Phase 3 efficacy study in opioid experienced subjects.

BioDelivery Sciences has also developed BUNAVAIL, the first FDA-approved formulation of buprenorphine and naloxone involving buccal administration for the maintenance treatment of opioid dependence. BUNAVAIL has twice the absorption of buprenorphine compared to the market leader in this category allowing the drug to be administered at half the dose to get the same effect; naloxone is included as an abuse deterrent. Both BELBUCA and BUNAVAIL were both designed using an advanced drug delivery technology known as BioErodible MucoAdhesive (BEMA®). This bioerodible polymer film for application to the mucosal membranes allows for the efficient delivery of buprenorphine while potentially overcoming some of the administration challenges presented by sublingual dosage forms.

Dr. Sirgo's company has also developed an important website (inreachassist.com) and app (initially available for the iPhone here) called InReach™. InReach, which went online in December 2014, offers a comprehensive array of information and resources on the management of opioid dependence to support patients and their families.* It helps identify personal goals and progress; track moods, triggers and medication; record appointments; and create boards of messages and photos to help keep users positive throughout the recovery process. InReach is not a substitute for a voluntary rehabilitation program.

Innovations such as those undertaken by BioDelivery Sciences offer new options that could bring with them the potential for better treatment for those dealing with the consequences of opioid addiction.

Source:

BioDelivery Sciences

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