The FDA approved the first non-opioid drug, Lofexidine hydrochloride (Lucemyra), to help treat symptoms of opioid withdrawal in adults.
The FDA found the drug to be safe and effective in easing symptoms such as diarrhea, nausea, vomiting, anxiety, and an overall feeling of sickness that often keep patients from withdrawing from opioids.
The FDA in a news release said Lofexidine may ease withdrawal symptoms but may not completely prevent them.
The drug is approved for treatment for only up to 14 days. It is not a treatment for opioid use disorder but can be used as part of a broader, long-term treatment plan for managing it.
Sharon Hertz, MD, director of the Division of Anesthesia, Analgesia, and Addiction Products in the FDA’s Center for Drug Evaluation and Research, said in the 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.”
In a statement, Health and Human Services Secretary Alex Azar called the approval a “welcome step forward.”
The drug was tested in two clinical trials involving 866 adults dependent on opioids who abruptly stopped using the drugs.
Low blood pressure, a slower than normal heart rate, sleepiness, and dizziness are the most common side effects of the drug.
The non-opioid Lofexidine was also associated with a few cases of fainting and may also make abnormal heart rhythms more likely.
People who use it may have higher blood pressure once they stop. Its safety and how well it works is not known in people younger than 17.