The FDA Just Approved a Groundbreaking Opioid Withdrawal Drug

The FDA has approved a drug that can help to ease the symptoms of opioid withdrawal, and it could be an important tool in fighting America’s opioid epidemic.

The drug, known as Lucemyra, is already used in the United Kingdom (under the name lofexidine) and has a proven track record for helping patients manage opioid withdrawal symptoms.

“We know that the physical symptoms of opioid withdrawal can be one of the biggest barriers for patients seeking help and ultimately overcoming addiction,” DDA Commissioner Scott Gottlieb, M.D., is quoted as saying, “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.”

Opioid withdrawal symptoms can be aggressive. These include loss of sleep, nausea, vomiting, diarrhea and drug craving, among many other problems.

Lucemyra helps to combat the anxiety and other symptoms that are associated with withdrawal. It is hoped that by offering this drug, patients will have a better chance of success when they decide to tackle an opioid abuse problem.

The FDA made this approval after double blind control trials showed that the drug had a recognizable effect on reducing patients’ reported withdrawal symptoms.

Trials have shown that Lucemyra does have some, sometimes significant, side effects, including low blood pressure and feelings of sedation. However, these effects can be managed, particularly for patients undergoing treatment for opioid addiction who will be seeing a health team regularly anyway.

The FDA is ordering further studies on the more longterm risks of Lucemyra use for periods above the 14 day window currently prescribed. It also wants to see what effects the drug might have on children.

How does the drug work?

When people come off of opioids, they experience a “surge” or nuerochemicals that creates acute symptoms like anxiety, nausea and more. Lucemyra is a non-opioid drug that can suppress that storm of neurochemicals and help relieve this suffering.

The drug, which will be made available this summer by drug company WorldMeds LLC, is designed to target what is known as the “peak” withdrawal period. It is administered via three tablets taken four times a day around five to seven days after last opioid use. The treatment window can last for up to 14 days.

Discontinuing the drug should be done with gradual dose reduction over a couple of days. Research is looking at whether that window can be safely extended to help with the tapering off of the drug.

Lucemyra is not an addiction cessation drug, meaning that it will not treat opioid misuse. However, it is hoped that by relieving symptoms patients will be better placed for therapy and other addiction-ending treatments.

This will be the first FDA-approved, non-opioid withdrawal treatment drug on the US market, so it is a groundbreaking moment for opioid addiction treatment.

The opioid epidemic has killed so many that there are actually significantly more organs available for organ transplants. Barring other disease factors, these organs are not any less safe, either. This is a sobering reminder of just how rampant opioid addiction has become, and its devastating effects, particularly among poorer and rural neighborhoods.

Six more states have also recently joined a lawsuit against opioid drug manufacturer Purdue Pharma for allegedly pushing the drugs, even when the company knew they were ineffective for many forms of chronic pain treatment and were highly addictive.

Photo credit: Thinkstock.

39 comments

Marie W
Marie W3 months ago

Thank you for posting.

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Cindy S
Cindy Smith8 months ago

thanks

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Monica C
Monica Collier9 months ago

The problem is that the political idiots are telling physicians what to prescribe.

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Winn A
Winn Adams9 months ago

Thanks

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Winn A
Winn Adams9 months ago

What took them this long and how much is the cost and who gets all the profits?

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Christina S
Past Member 9 months ago

I would like the FDA to stop allowing pharma to peddle their drugs on tv. Every other commercial is "take a pill and be ".

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Christina S
Past Member 9 months ago

It's too bad that pain meds, which have been proven to reduce symptoms, is villified because morons will not smarten up. Heroin is more a problem. If this helps, great. But until an addict hits rock bottom & decides to clean up, a withdrawal pill is not going to stop them. It's about escaping reality.

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Muff-Anne York-Haley

I don’t know about this.

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Beverly S
Beverly S9 months ago

So BigPharma made billions from the opioid problem that they manufactured, and now they'll make billions from the solution they manufactured for the problem they manufactured.

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Alea C
Alea C9 months ago

It doesn't say how much each pill costs, but I bet it's going to be a bundle. How about legalizing pot, as that would keep people from going on opiods in the first place.

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