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What you need to know about the latest FDA approval.
The FDA has approved Lucemyra (lofexidine hydrochloride, US WorldMeds LLC) for mitigation of opioid withdrawal symptoms in adults. Lucemyra is not a treatment for opioid use disorder (OUD), but may lessen the severity of withdrawal symptoms and is only approved for use up to 14 days. The drug can be used as part of a broader, long-term treatment plan for managing OUD, however.
Symptoms of opioid withdrawal include feeling sick, stomach cramps, muscle spasms/twitching, feeling of coldness, heart pounding, muscular tension, aches and pains, yawning, runny eyes and insomnia/problems sleeping.
“We know that the physical symptoms of opioid withdrawal can be one of the biggest barriers for patients seeking help and ultimately overcoming addiction,” says FDA Commissioner Scott Gottlieb, MD. “The fear of experiencing withdrawal symptoms often prevents those suffering from opioid addiction from seeking help. And those who seek assistance may relapse due to continued withdrawal symptoms.”
Lofexidine is a selective alpha 2-adrenergic receptor agonist that reduces the release of norepinephrine, which is believed to play a role in many of the symptoms of opioid withdrawal. The safety and efficacy of lofexidine was supported by two randomized double-blind placebo-controlled clinical trials of 866 adults who were physically dependent on opioids and undergoing abrupt opioid discontinuation. Patients who were given lofexidine were more likely to complete the course of treatment than those who received placebo. Side effects for lofexidine include low blood pressure, slow heart rate, sleepiness, sedation, and dizziness.
The FDA is requiring 15 postmarket animal and human studies for lofexidine. Additional animal safety studies will be required to support use longer than 14 days or for use in children.
Lofexidine was originally intended to be a hypertension medication. It has been used in the United Kingdom to reduce opioid withdrawal symptoms since the early 1990s.
The FDA granted this application Priority Review and Fast Track designations, and an independent FDA advisory committee supported the approval of Lucemyra at a meeting held March.