FDA Approves a New Non-Opioid Medication for Opioid Withdrawal

FDA Approves a New Non-Opioid Medication for Opioid Withdrawal

The Food and Drug Administration (FDA) has approved a new non-opioid medication to help relieve the symptoms of opioid withdrawal.

Called Lucemyra™ (lofexidine hydrochloride), from US WorldMeds, the drug, an αlpha 2A adrenergic receptor agonist, is not a new drug, and has been used to relieve hypertension (high blood pressure).

It's also not new to opioid withdrawal treatment. In the UK, it's known as BritLofex™, and has been used for over 25 years to alleviate opioid withdrawal symptoms.

What's new is that it's the first non-opioid approved for opioid withdrawal by the FDA here in the US. The approval for Lucemyra follows a positive recommendation back in March by the FDA's Psychopharmacologic Drugs Advisory Committee.

According to an FDA statement,

lofexidine may lessen the severity of withdrawal symptoms but may not completely prevent them. And it's approved for treatment for only up to 14 days. Furthermore, lofexidine is not a treatment for opioid use disorder (OUD). But it can be used as part of a broader, long-term treatment plan for managing OUD, the FDA said in a news release.
"Today's approval represents the first FDA-approved non-opioid treatment for the management of opioid withdrawal symptoms and provides a new option that allows providers to work with patients to select the treatment best suited to an individual's needs," said Sharon Hertz, MD, director of the Division of Anesthesia, Analgesia and Addiction Products in the FDA's Center for Drug Evaluation and Research.

US Department of Health and Human Services (HHS) Secretary Alex Azar said the approval is a "welcome step forward."

"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. Evidence-based treatment for addiction saves lives, and HHS will continue to support efforts to develop new treatments and provide approved treatments to those in need," Azar said.

Safe and effective

The committee found the drug,

"to be both safe and effective in reducing symptoms such as diarrhea, nausea, vomiting, anxiety, and an overall feeling of sickness that often keeps patients from successfully withdrawing from opioids."

Safety and efficacy were demonstrated in two randomized, double-blind, placebo-controlled clinical trials involving 866 opioid-dependent adults undergoing abrupt opioid discontinuation.

"The studies assessed the benefit of lofexidine using the Short Opiate Withdrawal Scale of Gossop (SOWS-Gossop), which is a patient-reported outcome instrument that assesses opioid withdrawal symptoms," the FDA said. “[These symptoms 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."

Patients treated with lofexidine had lower scores compared with a placebo group, and more lofexidine patients completed the treatment than the placebo group.

"The most common side effects from treatment with Lucemyra include hypotension (low blood pressure), bradycardia (slow heart rate), somnolence (sleepiness), sedation and dizziness. Lucemyra was also associated with a few cases of syncope (fainting)," the FDA said. "Lucemyra [can affect] the heart's electrical activity, which can increase the risk of abnormal heart rhythms.
"When Lucemyra is stopped, patients can experience a marked increase in blood pressure. The safety and efficacy of Lucemyra have not been established in children or adolescents less than 17 years of age."

The FDA report added that 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 15 post-marketing studies, including both animal and human studies. Animal safety studies are needed to support longer-term use (such as during a gradual opioid taper in pain patients discontinuing opioid analgesics) and use in children. Clinical studies are needed to evaluate the safety of lofexidine in clinical situations where use of the drug might exceed the maximum 14-day treatment period for which it is currently approved, gather additional safety data on the effects of lofexidine on the liver, and further characterize the effects on blood pressure after lofexidine is stopped.

Lofexidine had fast-track designation and was reviewed under the FDA's priority review process.

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