Recently, I discovered that a Veteran’s Administration hospital (can’t they do anything right?) in Wisconsin has experienced a fourfold increase in opioid use between 2005 and 2012 and earned the nickname Candy Land as a result. Since I had just been assigned the task of writing this, my first editorial for DDNews, and had covered the subject of opioid addiction for our Feb. Q&A feature, I thought I would look into the issue further.
As Mark Sirgo, president and CEO of BioDelivery Sciences Inc., told our readers in the Q&A, there are more than two million people in the United States who were dependent on opioids as of 2012, according to the National Institute on Drug Abuse. There are five different classes: 1) heroin, which has no medical value; 2) morphine, oxycodon and hydrocodone; 3) buprenorphine, which is both an agonist and antagonist and exhibits a low propensity to develop a “high” or craving; 4) antianxities such as diazepam and alprazolam; and finally, 5) cough syrup with codeine. Sirgo’s company has developed a buccal patch that allows buprenorphine to be easily and quickly absorbed to enhance bioavailability and patient compliance.
Dr. Eliseo Salinas notes that Relmada Therapeutics, where he is president and chief scientific officer, has four pain meds in the pipeline—one of which is buprenorphin—that collectively reflect a diverse range of reformulation and repositioning strategies. Their efforts are targeting improved efficacy as well as reduced risk of abuse and new drug delivery technologies. Here’s an “executive summary” as Salinas describes it:
d-Methadone: Researchers at Relmada have identified a process where they can separate out the “d” from the “l” isomer in methadone, an NMDA (N-methyl D-aspartate) agonist, to create a new molecule with the benefits of methadone that may not have the addictive properties. The low abuse potential of the new molecule may open new avenues for the treatment of neuropathic pain, a chronic pain condition that can affect people after a stroke or with multiple sclerosis, HIV infection, diabetes and other conditions.
LevoCap ER: The Relmada research team is working to develop an extended-release, tamper-resistant form of levorphanol for the treatment of chronic pain when an opioid is needed. Stronger than morphine, it was created as its alternative more than 40 years ago. There is great demand for extended-release formulations for pain due to limited availability in the market today.
MepiGel: Here they are working on a reformulation of the local anesthetic mepivacaine for the treatment of neuropathic pain (postherpetic neuralgia and HIV-associated neuropathy). MepiGel is a topical formulation that has U.S. Food and Drug Administration Orphan Drug designation. As a topical formulation, it may provide greater ease of use and efficacy (skin penetration) for those with neuropathic pain. There are no other topical gel dosage forms for a local anesthetic for the treatment of neuropathic pain available today.
BuTab ER: Here the team is working to develop an oral dosage form of the opioid analgesic buprenorphine with modified release and improved oral bioavailability. All other forms of buprenorphine are either injected, use a patch or are sublingual, so a successful repositioning of this compound may make this the first tablet available.
Timothy Lepak is president and cofounder of the National Alliance of Advocates for Buprenorphine (NAABT), which is responsible for www.treatmentmatch.org that claims to have matched a total of more than 82,000 patients with 28,000 doctors nationwide, only about 10,000 of whom actually prescribe, he tells DDNews. The NAABT Patient/Physician Matching System is a centralized list of patients from which certified physicians can draw when they have an opening.
Ideally, when a patient decides he or she needs treatment, a phone call is made to a physician on the “Find a Certified Physician” list, and the patient gets an immediate appointment and is treated the next day. However, there is a limit on how many patients a doctor can treat, which began at 30 per year in year one and is now 100. The law specifies that there must be three societies who train physicians, but Lepak points out that the training is a mere eight hours.
The transition to buprenorphine goes quickly, Lepak notes and can be accomplished in only a few days. “We’re not switching one addiction for another,” he states. “It allows people to get their lives back.”
As with many mental health issues, there is help for those who have the pluck to reach out for it. And the research reported on here indicates more help is on its way. But if you persist, figuratively speaking, in squeezing the trigger on your morphine drip too often, you may wind up like many of the patients in Candy Land.