WASHINGTON -- The FDA approved the , in order to "facilitate abrupt discontinuation of opioids in adults," the agency said Wednesday.
said it will market the drug as soon as this summer, under the trade name Lucemyra.
"We know that the physical symptoms of opioid withdrawal can be one of the biggest barriers for patients seeking help and ultimately overcoming addiction," FDA Commissioner Scott Gottlieb, MD, said in the agency's announcement. "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."
"Approval today of the first non-opioid treatment for managing opioid withdrawal symptoms is a welcome step forward," HHS Secretary Alex Azar said in another news release issued Wednesday afternoon. "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."
Lofexidine is an oral, selective alpha 2-adrenergic receptor agonist that reduces the release of norepinephrine. "The actions of norepinephrine in the autonomic nervous system are believed to play a role in many of the symptoms of opioid withdrawal," the FDA said. Lucemyra is similar to clonidine, which FDA staff had noted in discussing the drug with an advisory committee in March, is often used off-label for opioid withdrawal symptoms.
Use of lofexidine should be part of a long-term treatment plan for patients stopping opioids when physically dependent, the FDA and US WorldMeds indicated.
Recommended dosing for lofexidine is three 0.18 mg tablets taken orally four times daily, when patients are experiencing peak withdrawal symptoms (generally 5 to 7 days following last use of opioids, the company said in a news release). Treatment may continue for up to 14 days and should be discontinued gradually over 2-4 days.
In its own announcement of the approval, US WorldMeds included the following cautions for patients:
- "Lucemyra will not stop you from craving opioids"
- "Lucemyra may lessen the severity of symptoms, but it may not completely prevent them"
- "Alcohol, barbiturates, and benzodiazepines should be used with caution"
- "Tell your healthcare provider if you have ever been diagnosed with kidney disease or liver disease"
- "It is important to stay hydrated"
The FDA said it would be requiring 15 postmarketing studies on lofexidine, "including both animal and human studies" to examine whether the drug could also be used in gradual opioid tapers and in pediatric patients, and also to better understand potential effects on blood pressure and hepatic function. Safety and efficacy in patients younger than 17 has not been established, the agency noted.
Lofexidine's safety and efficacy in adults were supported by two randomized, double-blind, placebo-controlled clinical trials; they were reviewed during a meeting of the FDA's Psychopharmacologic Drugs Advisory in late March. In votes of 12-0 and 11-1, the committee backed approval for relieving opioid withdrawal symptoms in physically dependent patients who abruptly stop opioids and for keeping them in withdrawal treatment. The FDA had granted the drug's application Priority Review and Fast Track designations.
Great Britain approved lofexidine in the mid-1980's to relieve symptoms "in patients undergoing opiate detoxification," with patients in the 1990's typically taking doses between 1.6-2.2 mg for a median of 10 days, according to an FDA review.