LOUISVILLE, Ky. — US WorldMeds  announced that the U.S. Food and Drug Administration (FDA) approved Lucemyra (lofexidine) for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults. The FDA reviewed Lucemyra under Priority Review, which is granted to submissions for medications that would provide significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions.

Lucemyra suppresses the neurochemical surge that produces the acute and painful symptoms of opioid withdrawal. These symptoms may include aches/pains, muscle spasms/twitching, stomach cramps, muscular tension, heart pounding, insomnia/problems sleeping, feelings of coldness, runny eyes, yawning and feeling sick.

“Lucemyra offers new hope to people who want to discontinue opioid use and are struggling with the agonizing symptoms of opioid withdrawal,” said P. Breckinridge Jones, chief executive officer and founder of US WorldMeds. “We are humbled to bring to market the first and only non-opioid treatment for the mitigation of withdrawal symptoms – and are grateful for the urgency demonstrated by the FDA in rapidly reviewing and approving this important treatment.”

The FDA’s approval of Lucemyra is supported by two randomized, double-blind, placebo-controlled clinical trials, an open-label study and clinical pharmacology studies with concomitant administration of either methadone, buprenorphine or naltrexone. The product’s development also involved a grant from and close collaboration with the National Institute on Drug Abuse, part of the National Institutes of Health.

Data show that compared to placebo, participants treated with Lucemyra experienced less severe withdrawal symptoms and were significantly more likely to complete a seven-day opioid discontinuation treatment. Reported adverse side effects include low blood pressure or symptoms such as lightheadedness, slow heart rate, dizziness, sleepiness, feeling faint at rest or when standing up, and dry mouth.

Lucemyra is not an opioid drug and is not a treatment for opioid use disorder (sometimes known as opioid addiction). For people who have been diagnosed with opioid use disorder, withdrawal management alone, with or without Lucemyra, is not recommended; Lucemyra should be used as part of a long-term treatment plan created by a healthcare provider.

“Lucemyra presents an important new tool to help people make it successfully through withdrawal, which is very often critical for linking to ongoing continuing care and next steps in treatment for opioid dependence or addiction,” said Marc Fishman, MD, medical director, Maryland Treatment Centers and assistant professor, Johns Hopkins University School of Medicine.

Lucemyra is usually administered in three 0.18 mg tablets taken orally four times daily at five- to six-hour intervals during the period of peak withdrawal symptoms (generally five to seven days following last use of opioids); total treatment may continue for up to 14 days. Lucemyra should be discontinued with gradual dose reduction over two to four days.

Lucemyra is expected to be commercially available in the United States in August 2018.