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ASHINGTON — The Food and Drug Administration on Wednesday approved for the first time a drug meant to mitigate the symptoms of opioid withdrawal — rather than an underlying dependency — giving American physicians a new tool to help patients begin treatment.

The drug, lofexidine, will be manufactured by Kentucky-based US WorldMeds and marketed as Lucemyra.

The new drug is viewed as an important bridge to some forms of medication-assisted treatment, which have been the focus of many state and federal efforts to improve addiction treatment and have been seen as an effective way to help many patients.

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Some forms of medication-assisted treatment are opioids, like methadone or buprenorphine, both treat an underlying addiction and help withdrawal symptoms.

Another popular form of MAT is Vivitrol, which blocks the brain’s uptake of opioids but requires a detox period of at least a week. For individuals experiencing withdrawal symptoms, that week can be agonizing, with symptoms including nausea, diarrhea, muscle aches, anxiety, and insomnia.

The approval of lofexidine, which has long been used in Europe, may offer a way to help avoid such situations.

“It won’t completely eliminate symptoms of withdrawal,” said Dr. Mark Pirner, the senior medical director at US WorldMeds. “But for places and people where withdrawal is perpetuating higher opioid use, then Lucemyra is an appropriate therapy.”

Stefan Kertesz, a professor at the University of Alabama-Birmingham’s medical school who specializes in addiction, agreed.

“Lofexidine might make it easier to make that transition giving patients with addiction a way to get through withdrawal symptoms without receiving an opioid as part of the weaning process,” he said. “If you are really excited about naltrexone (Vivitrol) for treating people with opioid addiction, then lofexidine might be helpful.”

Lofexidine, like Vivitrol, is a non-opioid, meaning it has no potential for diversion or abuse. That differentiates it from two other forms of MAT meant to treat an underlying addiction but that often mitigate withdrawal symptoms: methadone and buprenorphine. And similarly to Vivitrol, no waiver will be required to prescribe Lucemyra.

In an interview, Pirner also suggested the drug could be helpful in some settings where doctors are attempting to reduce opioid dosages. An FDA advisory committee, however, said there was no evidence the drug would help “when used in the extremely common scenario of gradual opioid taper.”

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Kertesz, too, said the drug should not be viewed as a tool to aid dosage reductions.

“When opioid doses are reduced in voluntary patients as part of a care plan, some do well,” he said. “But then the key is to provide a comprehensive plan of support and just reduce the dose slowly. You don’t need lofexidine. You need a consenting patient and professional staff.”

The FDA’s announcement Wednesday came after an 11-1 vote by an advisory panel in March to recommend approval.

The agency had previously granted the application priority status in 2017. Nearly 50,000 Americans died in 2016 from opioid-related overdoses, and public health experts uniformly agree that the standard of care for opioid use disorder treatment — MAT coupled with counseling — is dramatically underutilized.

The FDA only approved the drug for treatment lasting 14 days or less, citing in a statement side effects including dizziness, low blood pressure, low heart rate, and occasional instances of fainting.

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  • Jo,

    It was just approved here. You must be in Europe. Do you have chronic pain? Your said you have been using it for years; so does that mean its a maintenance drug? What are the side effects?

    • Hi Sue,

      No sorry, I wasn’t very clear, I am the unit manager & prescriber at a residential detox unit in the UK.

    • Jo

      Thanks for clearing that up; because I was trying to figure out if you were the prescribing or the patient. I guess your dealing primarily with addiction. Here in the US they are cutting back and denying pain patients opioids. Patients who have been responsibly using them as prescribed.

  • Thanks FDA. How about labeling the indication for already-existing drugs like Clonidine (which has the exact same mechanism of action), that are inexpensive and already in use off-label, rather than allowing big Pharma to waste resources on expensive re-treads?

    • Clonidine has far greater adverse effects than Lofexidine & as you suggested is being used off-licence. I have been using Lofexidine as an adjunct to opiate withdrawal for years, it is safe & has definitely increased my units retention & completion rates when detoxing clients from opiates.

  • Good news, hope it is priced right. Everyone already uses Clonidine which is very inexpensive. Protocols also include muscle relaxers and Trazadone for sleep. Partial opioid agonists in combo with Nalaxone or Naltrexone is standard of care, in addition to receiving psycho- social counseling.

    • How does this drug treat patients with legitimate pain????? Will they be forcing this drug on those patients who are already suffering by being cut back on their medications or abruptly denied access to pain relief. All of this has been thought out before they proceeded to destroy quality of life for people using pain medication responsibly under a Doctors supervision. They are not the people dying from overdose and they know it. All of this time and millions of dollars should be focusing on our broken health care system that continues to decline. Denial, delays, neglect and red tape. Its disgusting. Spend some time looking into the medicaid fraud that I have to deal with. The epitome of corruption. A hopeless situation when you have a life threatening illness.

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