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etvfutures.com May 24, 2018


FDA Approves First Non-Opioid For Management Of Opioid Withdrawal Symptoms

18 May 2018, 03:58 | Lena Norman

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 fear of experiencing withdrawal symptoms often prevents those suffering from opioid addiction from seeking help", FDA Commissioner Dr. Scott Gottlieb said in a statement.

We believe such guidelines could encourage the use of an appropriate dose and duration of an opioid for some common procedures and promote more rational prescribing, including that patients are not being under prescribed and patients in pain who need opioid analgesics are not caught in the cross hairs.

Privately held US WorldMeds said it had not yet set a price for Lucemyra.

The drug helps with symptoms like vomiting, muscle pain, diarrhea and agitation.

Drug withdrawal symptoms can now be eased by a new nonopioid treatment approved by Federal regulators on Wednesday, the first to ease withdrawal from quitting addictive opioids. We know that the physical symptoms of opioid withdrawal can be one of the biggest barriers for patients seeking help and ultimately be overcoming addiction. "And those who seek assistance may relapse due to continued withdrawal symptoms", the FDA said in a May 16 statement.

Historically, opioid withdrawal is managed by substituting a different opioid and slowly reducing the dosage over time.

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The FDA says that Lucemyra decreases the release of norepinephrine, a chemical that mobilizes the body for action. The wellbeing and adequacy of Lucemyra was upheld by two randomized, twofold visually impaired, fake treatment controlled clinical trials of 866 grown-ups meeting Diagnostic and Statistical Manual-IV criteria for opioid reliance who were physically subject to opioids and experiencing unexpected opioid end. Each of the symptoms were rated by the patients as either "none, mild, moderate and severe".

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.

The data showed patients treated with Lucemyra reported lower SOWS-Gossop scores vs placebo. Lucemyra can also effect the heart's electrical activity, which can increase risk of abnormal heart rhythms. The wellbeing and viability of Lucemyra have not been built up in kids or young people under 17 years old. Notably, the application for Lucemyra received Priority Review and Fast Track designations.

US WorldMeds - a former Vogt Award victor in Louisville - "has been developing the data needed for FDA approval for over 10 years", he said, adding, "Being a Louisville-based company is a main priority and one of the core mission visions of US WorldMeds".

The FDA said it would be requiring 15 postmarketing studies on lofexidine, "including both animal and human studies" to examine whether the drug could also be used in gradual opioid tapers and in pediatric patients, and also to better understand potential effects on blood pressure and hepatic function.



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