May 17, 2018 -- 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.
Lofexidine may ease withdrawal symptoms but may not completely prevent them. It 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, 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," 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.
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.
The most common side effects of the drug include low blood pressure, a slower than normal heart rate, sleepiness, and dizziness. 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.
The FDA is requiring 15 post-marketing studies -- or studies that happen after a drug is approved. They include both animal and human studies. Animal safety studies will look at the drug's longer-term use and its use in children, the agency said.
Human studies are needed to find out how safe lofexidine is if it’s used for longer than the maximum 14-day treatment period, to get more data on how safe it is for the liver, and to further study its effects on blood pressure after it is stopped.
Lofexidine had fast-track designation and was reviewed under the FDA's priority review process.