First non-opioid treatment for withdrawals gets FDA approval

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Lucemyra, a selective alpha 2-adrenergic receptor agonist, works by reducing the release of norepinephrine and decreasing sympathetic tone; the actions of norepinephrine in the autonomic nervous system are believed to play a role in numerous symptoms of opioid withdrawal.

The FDA said its decision to approve the drug was supported by data gathered from two clinical studies involving 866 clinically opioid-dependent adults, following abrupt discontinuation of use.

Federal regulators have approved the first nonopioid treatment to ease withdrawal symptoms from quitting addictive opioids.

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In a blog post published on Monday, Scott Gottlieb, the Food and Drug Administration commissioner, said the FDA is listening to opioid-related concerns from patients with chronic pain.

"A better understanding of opioid withdrawal represents an opportunity in the prevention, treatment and recovery process for physical opioid dependence and opioid use disorder", co-author, Mark Pirner, MD, PhD, Senior Medical Director, Clinical Research and Medical Affairs, US WorldMeds, previously told MD Magazine. Treatment with Lucemyra may lessen the severity of opioid withdrawal symptoms but it 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.

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The drug has not been evaluated in people under age 17, the FDA said. These side effects incorporate feeling wiped out, stomach issues, muscle fits/jerking, feeling of coldness, heart beating, strong pressure, a throbbing painfulness, yawning, runny eyes and a sleeping disorder/issues dozing. Plus, patients who got Lucemyra were more likely to complete the course of treatment, which can only last for up to 14 days. The studies evaluated benefit using the Short Opiate Withdrawal Scale of Gossop (SOWS-Gossop), which is a patient-reported outcome instrument that assesses opioid withdrawal symptoms.

Patients usually manage withdrawal symptoms by switching the opioid with another medication or by using therapy. Lucemyra was also associated with a few cases of syncope (fainting).

In 2016, opioid-related overdoses in the US led to more than 42,000 deaths-a toll that exceeded the number of people killed in auto crashes. Clinical studies will be required to evaluate the safety of Lucemyra in clinical situations where use could be expected to exceed the maximum 14-day treatment period for which the product is now approved, such as gradual opioid taper; to gather additional safety data on the effects of lofexidine on the liver; and to further characterize the effects on blood pressure after lofexidine is stopped.

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

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