FDA approves 1st nonopioid drug to ease withdrawal symptoms

Henrietta Brewer
May 17, 2018

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 non-opioid tablets can be used for up to two weeks. Some patients - or doctors - may prefer an option like Lucemyra to ease withdrawal symptoms, as it the drug does not contain opioids.

Withdrawal symptoms from opioids are often very hard to manage, but the approval of a new treatment could change all of that for patients.


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. The approved treatment period is up to 14 days. The wellbeing and viability of Lucemyra have not been built up in kids or young people under 17 years old.

Lucemyra is an oral, selective alpha 2-adrenergic receptor agonist that reduces the release of norepinephrine. "I applaud the work of the FDA as well as the National Institute on Drug Abuse, which supported clinical studies of the treatment, in prioritizing efforts to prevent and treat opioid addiction". "The actions of norepinephrine in the autonomic nervous system are believed to play a role in numerous symptoms of opioid withdrawal", 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.

The data showed patients treated with Lucemyra reported lower SOWS-Gossop scores vs placebo. When Lucemyra is stopped, patients can experience a marked increase in blood pressure. After a period of not using opioid drugs, patients may be more sensitive to the effects of lower amounts of opioids if relapse does occur, and taking opioids in amounts that were used before withdrawing from opioids can lead to overdose and death.


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.

Clinical studies will be required to evaluate the safety in situations where use could be expected to exceed the maximum 14-day treatment period for which Lucemyra is now approved; to gather additional safety data on the effects of lofexidine on the liver; and to further characterize the effects on blood pressure after treatment is stopped. In short, having sound, evidence-based information to inform prescribing can help ensure that patients aren't over prescribed these drugs; while at the same time also making sure that patients with appropriate needs for short and, in some cases, longer-term use of these medicines are not denied access to necessary treatments. The drug should be available by the summer.


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