(RxWiki News) The US Food and Drug Administration (FDA) has approved the first non-opioid treatment option for managing opioid withdrawal symptoms.
The FDA’s approval of Lucemyra (lofexidine hydrochloride) is part of the agency’s ongoing effort to expand treatment options for opioid addiction and related conditions.
Lucemyra was approved for use in adults for up to 14 days. The FDA noted that this medication may reduce opioid withdrawal symptoms, but it might not totally prevent them.
Opioid addiction is a growing public health problem that has been linked to countless deaths due to overdose. Those who are addicted to opioid painkillers may experience severe withdrawal symptoms when they quit taking opioids.
Withdrawal symptoms can include drug cravings, diarrhea, nausea, vomiting, sweating, runny nose, muscle aches, sleep problems, agitation and anxiety. The FDA noted that withdrawal symptoms are often the biggest barrier keeping those who are addicted to opioids from seeking the help they need.
The typical treatment for opioid addiction is a different opioid — the dose is slowly tapered off and combined with assistance drugs like methadone. Lucemyra is the first non-opioid treatment option meant to manage withdrawal symptoms.
The FDA approved this drug after two studies found that it helped patients manage their withdrawal symptoms better than a placebo. Common side effects included dizziness, feeling tired, slow heart rate and low blood pressure, as well as some cases of fainting. Lucemyra may also raise the risk of abnormal heart rhythms, according to the FDA.
The FDA is requiring additional studies to further assess the safety and effectiveness of Lucemyra.
If you are concerned about opioid dependence or a related problem, reach out to your health care provider for help.
The FDA approved Lucemyra for US WorldMeds LLC.