WASHINGTON, May 16 (Xinhua) -- The U.S. Food and Drug Administration (FDA) approved on Wednesday a new drug called Lucemyra for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults.
Lucemyra or lofexidine hydrochloride may lessen the severity of withdrawal symptoms, but it may not completely prevent them and is only approved for treatment for up to 14 days, according to FDA.
Lucemyra is not a treatment for opioid use disorder (OUD), but can be used as part of a broader, long-term treatment plan for managing OUD.
Opioid withdrawal includes symptoms such as anxiety, agitation, sleep problems, muscle aches, runny nose, sweating, nausea, vomiting, diarrhea and drug craving that occur after stopping or reducing the use of opioids in anyone with physical dependence on opioids.
Physical dependence to opioids is an expected physiological response to opioid use.
These symptoms of opioid withdrawal occur both in patients who have been using opioids appropriately as prescribed and in patients with OUD.
"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, director of the Division of Anesthesia, Analgesia and Addiction Products in the FDA' s Center for Drug Evaluation and Research.
Lucemyra 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 safety and efficacy of Lucemyra 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.
Opioids, including prescription opioids, heroin and fentanyl, killed more than 42,000 Americans in 2016, more than any year on record, according to the U.S. Centers for Disease Control and Prevention.