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The FDA wants to make sure doctors don’t respond to the ongoing opioid epidemic by over-prescribing another class of addictive drugs—nerve pain drugs advertised on television regularly.
Known as gabapentinoids, these drugs, like Pfizer Inc.’s Neurontin (gabapentin) and Lyrica (pregabalin), are approved for a variety of conditions, including postherpetic neuralgia, fibromyalgia, and neuropathic pain. A substance abuse specialist told Bloomberg Law gabapentinoids can be addictive and prescriptions are on the rise. In fact, gabapentin was the tenth most commonly prescribed medication in the U.S. in 2016, with 64 million prescriptions dispensed that year, up from 39 million in 2012, according to an August 2017 article published in the New England Journal of Medicine.
The Food and Drug Administration is investigating whether their abuse or misuse is also increasing and, if so, what should be done to address the problem, FDA Commissioner Scott Gottlieb said Feb. 15. Doctors told Bloomberg Law potential actions on these drugs should include more education for prescribers on their abuse potential and possibly their categorization as controlled substances.
“It makes a lot of sense for the FDA to look into it,” Kent Runyon, chief strategy and compliance officer of Novus Medical Detox, a Florida-based drug and alcohol addiction treatment center, told Bloomberg Law Feb. 16.
Runyon said before the opioid epidemic, opioid prescriptions rose dramatically. “We’re seeing that same trend now with this medication,” and “that’s certainly a red flag.”
One reason for the increase in prescriptions is that doctors are looking for alternatives to opioids, but “it’s a risk if those alternatives put another medication into people’s hands that can be abused, can be addictive, or can be misused by people who are already misusing other medications to get a better high,” Runyon said.
As part of its investigation, the FDA is looking at social media sites where opioid users share comments that describe methods for misusing or abusing gabapentinoids, Gottlieb said at a workshop on the opioid epidemic sponsored by the Duke Margolis Center.
Gottlieb also said the FDA’s surveillance and epidemiology group, which is focused on spotting early patterns of abuse of controlled substances, is investigating the use patterns of gabapentinoids.
“We’ll have more to say about our work on this challenge soon. Our swift attention to this matter is, in part, a consequence of the lessons of history,” Gottlieb said. “We need to investigate and respond to signs of abuse as soon as any signal emerges. We need to get ahead of these problems.”
The FDA also is continuing its work to reduce the impact of opioid abuse and addiction. On April 17, the agency will hold a public meeting on patient-focused drug development for opioid use disorder. Specifically, the agency is interested in hearing from patients about their experience using prescription medical treatments and other treatments for opioid use disorder and challenges or barriers to assessing these medical treatments.
Runyon said in his clinic they’re seeing people needing to detox off of a gabapentinoid, but it’s always in conjunction with other medications. People struggling with substance abuse disorders are using gabapentinoids to increase the euphoric effects of other substances, including opioids, he said.
“I think we need to do more with education around this medication” for physicians on its abuse potential, Runyon said. He also said it makes sense to consider making gabapentinoids a controlled substance. A controlled substance is a drug whose manufacture, possession, or use is regulated by the Drug Enforcement Administration.
The consumer group Public Citizen agrees there is good reason to be concerned about the abuse potential of gabapentinoids, Michael Carome, director of the Washington-based organization’s health research group, told Bloomberg Law in a Feb. 15 email.
“Historically, gabapentin was presumed to not have an abuse potential. However, there is growing evidence to the contrary,” Carome said. For example, he said, a 2015 study published in the American Journal of Psychiatry showed an almost 3,000 percent increase in the recreational use of gabapentin from 2008 to 2014.
Also, the Advisory Council on the Misuse of Drugs, an independent body of experts that advises the U.K. government, has highlighted concerns over the misuse of gabapentin and pregabalin, and recommended that gabapentin and pregabalin both be classified as controlled substances, Carome said.
But there’s a concern that making gabapentinoids controlled substances would put burdens on the patients who need them.
“Less than two percent of people who take a gabapentinoid abuse it” and “to make it a controlled substance would make the rest of the 98 percent of the patients taking this medication go through lots of burdens,” Jianguo Cheng, president-elect of the American Academy of Pain Medicine (AAPM), told Bloomberg Law Feb. 16. They wouldn’t be able to get more than a certain amount of their medication, and they would be subject to other restrictions, he said. The AAPM, based in Chicago, represents physicians practicing in the field of pain medicine.
Cheng said there isn’t sufficient evidence to make gabapentinoids a controlled substance. Cheng also is a professor and physician at the Cleveland Clinic.
One doctor said a better alternative to opioids would be buprenorphine.
Buprenorphine doesn’t come with the risk of dependence and overdose, Greg Sullivan, a physician who was a principal investigator for all eight FDA studies on buprenorphine and chronic pain, told Bloomberg Law Feb. 15.
Sullivan also is the co-founder of Bridge Therapeutics Inc., based in Birmingham. Ala., which is pursuing FDA approval of a buprenorphine product for the treatment of chronic pain in opioid-experienced patients.
Currently, buprenorphine is only approved in the U.S. for the treatment of addiction. FDA-approved buprenorphine products include Suboxone, a film that dissolves under the tongue made by Indivior Plc, and Probuphine, an implant approved for treating opioid dependence made by Titan Pharmaceuticals Inc.
Sullivan said buprenorphine was originally developed as a pain drug in the 1970s. Patients who take the drug don’t have euphoria, and it has no sedation and overdose risks, he said.
If patients need to stay on a pain drug for more than the standard two weeks when pain becomes chronic, they could switch to buprenorphine and get pain relief without the problems of tolerance, dependence, and lack of pain control, Sullivan said.
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