FDA OKs first non-opioid treatment for opioid withdrawal

18 May 2018, 09:28 | Robert Harris

FDA OKs first non-opioid treatment for opioid withdrawal

FDA Approves Lofexidine Hydrochloride, First Non-Opioid Treatment for Management of Opioid Withdrawal Symptoms in Adults

The agency stressed that Lucemyra is not specifically approved for Opioid Use Disorder, and the drug's use shouldn't extend beyond 14 days.

The FDA's decision was supported by data gathered from two clinical studies that involved 866, clinically opioid-dependent adults, following abrupt discontinuation of use.

Lucemyra is produced by U.S. WorldMeds, based in Louisville, Ky.

For those addicted to opioids, quitting cold turkey can be a harrowing experience. For opioids, withdrawal symptoms can include runny noses, sleep problems, sweating, nausea, vomiting and more.

In patients using opioid analgesics appropriately as prescribed, opioid withdrawal is typically managed by slow taper of the medication, which is meant to avoid or lessen the effects of withdrawal while allowing the body to adapt to not having the opioid.

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The U.S. Nourishment and Drug Administration has endorsed the main nonopioid treatment to enable grown-ups to oversee opioid withdrawal side effects as the organization hopes to keep on encouraging the advancement of treatments to help patients experiencing dependence. "And those who seek assistance may relapse due to continued withdrawal symptoms", the FDA said in a May 16 statement.

The non-opioid medication, also known as lofexidine hydrochloride, could allow people take a crucial step toward getting off heroin or prescription opioids.

Developed under private company US WorldMeds, Lucemyra works by diminishing the release of norepinephrine, a neurotransmitter that relays feelings of pain and affects withdrawal symptoms, research suggests. Compared to placebo, Short Opiate Withdrawal Scale of Gossop scores were found to be lower for patients treated with Lucemyra, and more patients finished the treatment in the Lucemyra group versus the placebo group. "But for places and people where withdrawal is perpetuating higher opioid use, then Lucemyra is an appropriate therapy". Also, the patient may be more sensitive to the effects of lower amounts of opioids, so they could overdose or die if they go back to using opioids to the extent that they did before they stopped using opioids. More patients in the Lucemyra group completed the treatment period of the studies vs patients in the placebo group. The FDA reviewed Lucemyra under Priority Review, which is granted to submissions for medications that would provide significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions.

As part of a strategy to fight the crisis, the FDA said it's working to decrease opioid exposure to prevent new addictions and punish those who contribute to illicit opioid distribution.



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