US FDA approves first non-opioid withdrawal new drug
May 17, 2018 Source: WuXi PharmaTech
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Just now, the US FDA announced the approval of US WorldMeds' Lucemyra (lofexidine hydrochloride) to relieve withdrawal symptoms in adult patients who discontinued opioids. Although Lucemyra can alleviate the severity of withdrawal symptoms, it does not completely prevent these symptoms and can only be used for up to 14 days. It is worth noting that Lucemyra is not a drug for the treatment of opioid use disorder (OUD), but it can be used as part of a broader treatment plan for long-term treatment of OUD.
Opioid withdrawal symptoms can occur after any opioid-dependent person has discontinued or reduced the use of these drugs, including anxiety, irritability, sleep problems, muscle aches, runny nose, sweating, nausea, vomiting, Diarrhea and drug cravings. The physical dependence on opioids is the expected physiological response to opioid use. Opioid withdrawal symptoms can occur in patients who are on prescription for opioids and OUD.
In patients who are prescribed opioid analgesics as appropriate, opioid withdrawal is usually achieved by slowly reducing the dose, in order to avoid or reduce the effects of withdrawal, while at the same time adapting the body to no opioids. The role. In patients with OUD, abstinence is usually replaced with another opioid, and then gradually reduced or transferred to maintenance therapy (such as FDA-approved drug-assisted drugs such as methadone, buprenorphine or naltrexone) Or use a variety of medications for specific symptoms, such as over-the-counter medications for stomach upset or pain.
Lucemyra, approved today, is an oral selective alpha2-adrenergic receptor agonist that reduces the release of norepinephrine. The role of norepinephrine in the autonomic nervous system is thought to play a role in many of the symptoms of opioid withdrawal. The drug has received FDA-approved eligibility for eligibility for review and fast-track, and has received 11 to 1 votes from the FDA's Psychopharmacological Drugs Advisory Committee.
â–² Lofestine molecular formula (Source: by Vaccinationist (PubChem) [Public domain or Public domain], via Wikimedia Commons)
The safety and efficacy of Lucemyra was supported by two randomized, double-blind, placebo-controlled clinical trials. These clinical trials have a total of 866 adult patients who meet the diagnostic criteria for opioid dependence, who are physiologically dependent on opioids and are undergoing opioid withdrawal. These studies used the Gossop Short Suspension Dosing Scale (SOWS-Gossop) to assess efficacy, a tool for assessing opioid withdrawal symptoms by patient reporting. These symptoms include discomfort, stomach cramps, convulsions, cold feelings, strenuous heart, muscle tension, pain, yawning, tearing and insomnia.
For each opioid withdrawal symptom, patients need to use four modes of response: none, mild, moderate, and severe to assess the severity of their symptoms. The SOWS-Gossop total score ranges from 0 to 30, with higher scores indicating more severe withdrawal symptoms. The results showed that the patients in the Lucemyra group had lower SOWS-Gossop scores compared with placebo, and more patients in the Lucemyra group completed treatment than placebo.
â–² FDA Director Dr. Scott Gottlieb (Source: FDA)
“As part of our commitment to support addicted patients, we are committed to encouraging innovative ways to help alleviate the physical challenges of stopping opioids,†said FDA Director Dr. Scott Gottlieb. “We are developing new guidelines to help patients. Accelerate the development of better treatments, including those that help control opioid withdrawal symptoms. We know that opioid withdrawal symptoms may be one of the biggest obstacles to seeking help and ultimately overcoming addiction. The fear of broken symptoms often prevents those with opioid addiction from seeking help. Those who seek help may relapse because of persistent withdrawal symptoms. The FDA will continue to encourage innovation and development of treatments to help with opioids. Addicted patients transition to a sober life and address the unfortunate stigma associated with the use of drug-assisted therapies."
“Today's approval represents the first FDA-approved non-opioid for the treatment of opioid withdrawal symptoms and offers a new option to help doctors and patients choose the most appropriate treatment.†FDA Drug Evaluation and Dr. Sharon Hertz, Director of the Department of Anesthesia, Pain and Addiction Products at the Research Center, said.
We hope that the approval of this new drug will bring hope to people who are suffering from opioid withdrawal symptoms to restore a healthy life.
Reference materials:
[1] FDA approves the first non-opioid treatment for management of opioid withdrawal symptoms in adults
[2] us worldmeds official website
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