FDA approves first non-opioid drug for treating opioid withdrawal symptoms

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

The FDA approved the first non-opioid medication to treat opioid withdrawal in adults, in order to "facilitate abrupt discontinuation of opioids in adults", the agency said Wednesday.

The FDA found the drug to be safe and effective in easing symptoms such as diarrhea, nausea, vomiting, anxiety, and an overall feeling of sickness that often keep patients from withdrawing from 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.

Lofexidine may ease withdrawal symptoms but may not completely prevent them.

The newly approved drug isn't a medication for opioid addiction, but is seen as a step toward helping some people begin medication-assisted treatment, seen as the gold standard of addiction care.

For each withdrawal symptom, patients were asked to rate the severity using 4 response options (none, mild, moderate and severe) with the SOWS-Gossop total score ranging from 0-30-a higher score indicated a greater withdrawal symptom severity.

Lucemyra, an oral, selective alpha 2-adrenergic receptor agonist that reduces the release of norepinephrine, was reviewed by the FDA under a priority review. And those who seek assistance may relapse due to continued withdrawal symptoms. It is not an addiction medicine but can be part of a longer-term treatment plan, according to the FDA. Common side effects include a slow heart rate, low blood pressure, and sleepiness.

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Symptoms of opioid withdrawal vary.

US WorldMeds anticipates it can have its opioid withdrawal medication available to help patients by August. More data is also needed to determine Lucemyra's safety and efficacy profile in patients younger than 17 years of age. The safety and efficacy of Lucemyra was supported by two 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. Patients can experience any combination of these symptoms after ceasing opioid use. Participants treated with Lucemyra experienced less withdrawal symptoms when compared to participants who took the placebo instead. Two-thirds of drug overdose deaths in 2016 involved opioids, mostly fentanyl, heroin and prescription painkillers. They include both animal and human studies.

The FDA is requiring drugmaker US WorldMeds of Louisville, Kentucky, to conduct more studies in teens and newborns of opioid-addicted mothers and for possible longer-term use in people tapering off opioids.

As a major aspect of the U.S. Bureau of Health and Human Services' Five-Point Strategy to Combat the Opioid Crisis, the FDA stays focused on tending to the national emergency of opioid compulsion on all fronts, with a critical spotlight on diminishing presentation to opioids and averting new enslavement; supporting the treatment of those with opioid utilize scatter; cultivating the advancement of novel torment treatment treatments and opioids more impervious to manhandle and abuse; and making a move against the individuals who add to the unlawful importation and offer of opioid items. The agency will also continue to evaluate how drugs now on the market are used, in both medical and illicit settings, and take regulatory action where needed.

Manufacturer US WorldMeds said it will market the drug as soon as this summer, under the trade name Lucemyra.

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