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WASHINGTON — 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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  • What will this do for people who use prescription pain meds responsibly for daily yearly pain that never goes away …pain patients are being punished because of people using street drugs not prescribed by a doctor with conditions that are life long …

  • 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?

    • 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.

    • This issue sincerely needs to be addressed! Responsible chronic pain patients who are doing all they can to better their qualify of life are losing medication treatment when meds were their last resort and hope to really live and enjoy their families…People dying are not even being treated properly!!Thses are some very sad days we must live in.My daughter is afraid to go to hospital as we speak)for fear they will not address the pain of a bad kidney problem! What can be done?For all of the people suffering due to political issues and loss of much needed pain medication !l

  • 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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