FDA approves Lucemyra to mitigate opioid withdrawal symptoms.- US WorldMeds

US WorldMeds announced that the 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.

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.

The FDA is requiring 15 postmarketing studies, including both animal and human studies. Additional animal safety studies will be required to support longer-term use (such as during a gradual opioid taper in pain patients discontinuing opioid analgesics) and use in children. Clinical studies will be required to evaluate the safety of Lucemyra in clinical situations where use could be expected to exceed the maximum 14-day treatment period for which the product is currently approved, such as gradual opioid taper; to gather additional safety data on the effects of lofexidine on the liver; and to further characterize the effects on blood pressure after lofexidine is stopped. Studies in pediatric patients will include studies of newborns with neonatal opioid withdrawal and studies of different age groups of children who have opioid withdrawal related to stopping medically-prescribed opioid drugs. .

Comment: Lofexidine hydrochloride has been available in the UK since October 1990 to relieve symptoms in patients undergoing opioid detoxification and is marketed as a generic by Britannia Pharmaceiuticals.