U.S. - FDA Approves First Non-Opioid Treatment for Management of Opioid Withdrawal

S.J.B.

S.J.B.

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FDA Approves Lofexidine Hydrochloride, First Non-Opioid Treatment for Management of Opioid Withdrawal Symptoms in Adults
Jenna Payesko
MD Magazine
May 16th, 2018

The US Food and Drug Administration (FDA) approved lofexidine hydrochloride (Lucemyra) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults, announced US WorldMeds.

Lucemyra, not a treatment for opioid use disorder, can be used as a long-term treatment plan, however while it may lessen the severity of withdrawal symptoms, it may not completely prevent them and is only approved for treatment for up to 14 days.

"Today's approval represents the first FDA-approved non-opioid treatment for the management of opioid withdrawal symptoms and provides a new option that allows providers to work with patients to select the treatment best suited to an individual's needs," Sharon Hertz, MD, director, division of the anesthesia, analgesia and addiction products, in the FDA?s Center for Drug and Evaluation and Research, said in a statement.

The safety and efficacy was supported by 2 randomized, double-blind, placebo-controlled clinical trials of 866 adults meeting Diagnostic and Statistical Manual-IV criteria for opioid dependence who were physically dependent on opioids and undergoing abrupt opioid discontinuation.

The studies evaluated benefit using the Short Opiate Withdrawal Scale of Gossop (SOWS-Gossop) to assess opioid withdrawal symptoms that included feeling sick, stomach cramps, muscle spasms/twitching, feeling of coldness, heart pounding, muscular tension, aches and pains, yawning, runny eyes and insomnia.
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Read the full story here.
 
Anyone here have experience with this drug? I guess it's been around for a while in the U.K.
 
Sounds like just another version of clonidine, that is more pricy compared to clonidine in the US.

I would be surprised if clinical trials of this plus other first line detox meds would be more cost effective than with clonidine as standard.
 
This is kinda cool if it works the way it's supposed to. It's good to have another treatment but i can imagine that this drug will have the deficit of not doing a damn thing for cravings, which is an issue that needs to be addressed.

I wonder if they could maybe pair this drug up with a low dose of a low potency opiate to help with cravings and round off any withdrawal effects that are left.
 
That was my thought--a new way to market clonidine with something very similar enough to do the same thing but different enough to get the one thing Big Pharma loves the most--A New Patent!!! Many new dollars coming in for basically something that's been around forever--that's the Big Pharma way!
 
How the hell does this help with withdrawal? A blood pressure pill?

And the FDA wants to ban kratom, which actually works for me.
 
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treezy z said:
How the hell does this help with withdrawal? A blood pressure pill?
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Clonidine also happens to be a blood pressure medication which has been used in medication assisted detox for decades.

I found this on the Harvard Health Publishing Blog, and the only difference, it seems to me, is that this "new" medication doesn't cause as quite a dramatic drop in blood pressure as clonidine does. And I put new in quotes because it seems like this med has been around for a while. Would it even be under patent in the USA? I can't seem to find any information on that.
 
I'm sorry but this is akin to the off-label prescribing of clonidine to aid with opioid withdrawal, which, I've been on, and, frankly sucks. Gabapentin and Pregabalin were far more effective, I found. Yes, I know it's anecdotal, but I think they should consider taking a gander at Gabapentinoids (perhaps in combination with Clonidine).
 
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