FDA approves the first non-opioid to treat opioid withdrawal symptoms

US regulators approve the first non-opioid drug to treat opioid withdrawal symptoms

  • Lofexidine has been used for years to treat recovering addicts in Europe
  • On Wednesday, a Kentucky firm got the green light from the FDA to sell it
  • Currently addicts can take the opioid methadone, which targets their dependence, or the non-opioid Vivitrol - but that requires a one-week detox
  • This drug, sold as Lucemyra, is the first non-opioid that can be administered immediately, and targets withdrawal symptoms not drug dependence 

By Mia De Graaf Health Editor For Dailymail.com

Published: 17:14 EDT, 16 May 2018 | Updated: 21:37 EDT, 16 May 2018

The FDA has approved the first non-opioid drug to treat opioid withdrawal symptoms.

Until now, recovering addicts in America had two options: taking medically-assisted opioids like methadone to treat their underlying dependency, or enduring a week-long detox unmedicated before they can take the non-opioid Vivitrol to block their addiction.

But on Wednesday, US regulators gave the green light to lofexidine (sold under the brand name Lucemyra), after years of success treating recovering addicts in Europe.

It will be the first drug in America to directly mitigate symptoms of withdrawal, rather than targeting their addiction.

Experts say this distinction will be a breakthrough in the fight to cut the addiction cycle plaguing millions of Americans by making the transition exponentially easier.

The fact that is not an opioid, too, is seen as a major step in the right direction.  

On Wednesday, the FDA gave the green light to lofexidine (sold under the brand name Lucemyra), after years of success treating recovering addicts in Europe
On Wednesday, the FDA gave the green light to lofexidine (sold under the brand name Lucemyra), after years of success treating recovering addicts in Europe

On Wednesday, the FDA gave the green light to lofexidine (sold under the brand name Lucemyra), after years of success treating recovering addicts in Europe

'We know that the physical symptoms of opioid withdrawal can be one of the biggest barriers for patients seeking help and ultimately overcoming addiction,' said FDA Commissioner Scott Gottlieb, MD.

'The fear of experiencing withdrawal symptoms often prevents those suffering from opioid addiction from seeking help. And those who seek assistance may relapse due to continued withdrawal symptoms. 

'The FDA will continue to encourage the innovation and development of therapies to help those suffering from opioid addiction transition to lives of sobriety, as well as address the unfortunate stigma that's sometimes associated with the use of medication-assisted treatments.'   

Lucemyra, manufactured by Kentucky-based US WorldMeds, is only approved for treatment for up to 14 days.

It is taken orally, and works to subdue norepinephrine, a neurotransmitter which floods the body with the stress hormone if it detects a threat. 

While this is designed to be protective, it overreacts in cases of withdrawal, triggering a tumult of debilitating reactions.  

Opioid withdrawal can cause symptoms including anxiety, agitation, sleep problems, muscle aches, runny nose, sweating, nausea, vomiting, diarrhea and drug craving.

These come on within hours of a drug-dependent person stopping or cutting their  dosage of opioids - whether it's prescribed or sought out for abuse. 

Such agonizing symptoms are often the biggest barrier to getting clean. 


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