You will soon hear about an “amazing” new drug called Lucemyra (Lofexidine). It was just approved (fast tracked even) to treat patients with opioid withdrawal. Wow! This is just what we need, an amazing breakthrough drug that will allow tens of thousands of patients to get off opiates. This is the first non-opiate FDA approved drug to treat opiate withdrawal. This will surely end the opiate epidemic we struggle with today. Right?
Not so fast. The first error is believing that acute withdrawal is what’s keeping people addicted, It’s not. Many of these folks can get clean, they just can’t stay clean. This is why the addiction treatment community focuses on substitute medication and away from withdrawal treatment. Be that as it may if this drug really significantly reduces opiate withdrawal that would be awesome. Most opiate dependent patients are very withdrawal phobic. I would welcome a medication that truly minimized opiate withdrawal. However, throwing an armamentarium of medications at an opiate withdrawal patient doesn’t translate into treatment success. About 91% of patients in early recovery will relapse and most of those will be in the first week. 2
A drug called Clonidine has been used for decades to help treat opiate withdrawal. Clonidine is an alpha receptor agonist. It blunts the central nervous system response to the catecholamine surge from opiate withdrawal, although it’s official use is that of an anti-hypertensive. A prescription for clonidine, according to GoodRx is $4. It’s the most commonly prescribed drug used for acute opiate withdrawal and it’s almost always used in combination with other meds because it has a very small effect on its own. Clonidine has no official FDA indication for the treatment of opiate withdrawal, neither does gabapentin, hydroxyzine, methocarbamol or any number of commonly used agents. Clonidine seems to help patients feel a little better and it’s what we’ve all used for many years.
Lofexidine is the exact same drug class as Clonidine. Lofexidine is the European equivalent of Clonidine and has been used more overseas for the treatment of hypertension, similar to how clonidine is prescribed here. But since Clonidine is generic and cheap, no big pharma companies are going to push it through the FDA process to obtain an indication to treat opiate withdrawal, a process that cost millions. The folks at USWorld Meds, the manufacturer’s of Luceyma, were clever. They thought, hey those American’s are really suffering from an opiate crisis, let’s show the FDA that Lofexidine helps reduce opiate withdrawal and sell it over there for a ton of money…and they did.
There are two (industry sponsored) unpublished studies that compared Lofexidine to placebo and showed some improvement over nothing, but we already knew that. 3Patients who got nothing dropped out of treatment sooner. Patients were followed up less than 14 days, no intermediate or long-term successes were measured. What about Clonidine? Why not use that for a fraction of the price?
A study by S.L. Walsh.etc. al. 6 compared lofexidine to clonidine in acute withdrawal and found, “neither lofexidine nor clonidine suppressed the subjective discomfort of opioid withdrawal or significantly reduced other autonomic signs of opioid withdrawal.” A bigger question this raises is why we use clonidine at all. I’m not going there, but it certainly cements the fact that we shouldn’t be paying a ton more for Lucemyra (pricing not available at the time of this writing).
In my humble opinion, as an Addiction Medicine Physician who detoxes patients on a weekly basis, I can’t recommend Lucemyra over clonidine, especially given the fact that It will be probably be priced at least 100% higher (if not 1000%). I’m glad Pharma is addressing the opiate crises and the FDA is looking at implementing solutions which may be helpful. But it’s just lame and sad to repackage a ” me too” drug for a new indication to further profit from those suffering the disease of opiate addiction.
Ken Starr MD
Medical Director of the Wellness Group
Arroyo Grande, CA
References:
National Institute on Drug Abuse. (2014). America’s addiction to opioids: Heroin and prescription drug abuse.
Smyth, B. P., Barry, J., Keenan, E. & Ducray, K. (2010). Lapse and relapse following inpatient treatment of opiate dependence. Irish Medical Journal. 103(6),176–179.
C.W. Gorodetzky, A phase III randomized, multi-center, double blind, placebo controlled study of safety and efficacy of lofexidine for the relief of symptoms in individuals undergoing inpatient opioid withdrawal
National Institute on Drug Abuse. (2014). Drugs, brains, and behavior: The science of addiction.
Kosten, T. R. & George, T. P. (2002). The Neurobiology of Opioid Dependence: Implications for Treatment. Science & Practice Perspectives, 1(1), 13–20.
Walsh SL, Strain EC, & Bigelow GE (2002). Evaluation of the effects of lofexidine and clonidine on naloxone-precipitated withdrawal in opioid-dependent humans. Society for the Study of Addiction to Alcohol and Other Drugs.98, 427-439