Health & Fit FDA Approves Lucemyra For Treating Opioid Withdrawal Symptoms

12:50  17 may  2018
12:50  17 may  2018 Source:   medicaldaily.com

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If approved , Lucemyra will be the first and only non- opioid medication indicated for the mitigation of opioid withdrawal symptoms . The FDA will consider the Advisory Committee's non-binding recommendation in its review of the NDA for Lucemyra .

Lucemyra Approval Status. FDA approved : No. Brand name: Lucemyra . Lucemyra (lofexidine) is selective alpha 2-adrenergic receptor agonist in development for reducing the severity of withdrawal symptoms in patients experiencing opioid withdrawal .

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The United States Food and Drug Administration (FDA) has approved a nonopioid drug called Lucemyra for the treatment of opioid withdrawal symptoms in adults. Developing safe and effective treatments for opioid use disorder remained a major priority for the agency, stated a press announcement released on May 16.

Lucemyra (lofexidine hydrochloride) is administered orally and can be used to lessen the severity of withdrawal symptoms that may occur after the discontinuation of opioid use. It may not completely eradicate symptoms and was only approved for treatment for up to 14 days. The FDA also emphasized that the drug is not a treatment for opioid use disorder (OUD) but could be "used as part of a broader, long-term treatment plan for managing OUD."

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If approved , Lucemyra will be the first and only non- opioid medication indicated for the mitigation of opioid withdrawal symptoms . The FDA will consider the Advisory Committee's non-binding recommendation in its review of the NDA for Lucemyra .

If approved , LUCEMYRA will be the first and only non- opioid medication indicated for the mitigation of opioid withdrawal symptoms . The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date in the second quarter of 2018. About Opioid Withdrawal Opioids lower norepinephrine, a

Early symptoms of withdrawal can include anxiety, insomnia, muscle ache, and increased sweating. Late symptoms may involve nausea, vomiting, diarrhea and, dilated pupils. Such signs and responses are expected to occur in varying degrees, both in patients who used opioids correctly and in patients with OUD.

According to the National Institutes of Health (NIH), these symptoms can cause pain and discomfort but are usually not life-threatening. The biggest risk of experiencing severe symptoms is that the patient may be driven back into drug use.

Opioids © Opioids Opioids "Most opiate overdose deaths occur in people who have just detoxed. Withdrawal reduces the person's tolerance to the drug, so those who have just gone through withdrawal can overdose on a much smaller dose than they used to take," the NIH website stated.

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Overview of the March 27, 2018 PDAC Meeting on NDA 209229 for Lucemyra (lofexidine Many patients discontinuing opioids do so gradually, and the symptoms of withdrawal can often be lofexidine would be the first non- opioid approved for treating opioid withdrawal and the only

In 2016, more than 34,500 people died from overdosing on traditional and synthetic opioid painkillers, the National Center for Health Statistics estimates. Beyond that, the opioid epidemic affects millions of Americans, and it only seems to be getting worse.

Lucemyra works by reducing the release of norepinephrine, which is believed to play a key role in triggering withdrawal symptoms. As many as 866 adult participants demonstrated the benefits and safety of the drug in two randomized, double-blind, placebo-controlled clinical trials. Compared to the placebo group, patients treated with Lucemyra reported a lower severity of 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. The fear of experiencing withdrawal symptoms often prevents those suffering from opioid addiction from seeking help," said FDA Commissioner Dr. Scott Gottlieb. "And those who seek assistance may relapse due to continued withdrawal symptoms."

He added the administration will focus on developing more therapies to help those suffering from opioid addiction and address the stigmatization of medication-assisted treatments. More studies are being planned to understand the safety and efficacy of Lucemyra in children or adolescents under 17 years of age.

According to estimates, more than 115 people die each day in the U.S. after overdosing on opioids. The past year has seen an increase in the number of lawsuits filed against opioid manufacturers and distributors. On May 15, six states filed lawsuits against Purdue Pharma (the maker of prescription painkiller OxyContin) for misleading the public and fueling the on-going opioid crisis. 

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