The U.S. Food and Drug Administration on Wednesday approved https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm607884.htm the first non-opioid drug that will help reduce symptoms of opioid withdrawal in adults.
"The fear of experiencing withdrawal symptoms often prevents those suffering from opioid addiction from seeking help", FDA Commissioner Dr. Scott Gottlieb said in a statement. It is not an addiction medicine but can be part of a longer-term treatment plan, according to the FDA.
Early symptoms of withdrawal can include anxiety, insomnia, muscle ache, and increased sweating.
For each opioid withdrawal symptom, patients are asked to rate their symptom severity using four response options (none, mild, moderate and severe), with the SOWS-Gossop total score ranging from 0 to 30, where a higher score indicates a greater withdrawal symptom severity. These symptoms of opioid withdrawal occur both in patients who have been using opioids appropriately as prescribed and in patients with OUD.
The FDA says that Lucemyra decreases the release of norepinephrine, a chemical that mobilizes the body for action. The actions of norepinephrine in the autonomic nervous system are believed to play a role in numerous symptoms of opioid withdrawal.
Lucemyra (lofexidine hydrochloride) is administered orally and can be used to lessen the severity of withdrawal symptoms that may occur after the discontinuation of opioid use. 866 adults participated in the study.
"A better understanding of opioid withdrawal represents an opportunity in the prevention, treatment and recovery process for physical opioid dependence and opioid use disorder", co-author, Mark Pirner, MD, PhD, Senior Medical Director, Clinical Research and Medical Affairs, US WorldMeds, previously told MD Magazine. When Lucemyra is stopped, patients can experience a marked increase in blood pressure. And those who seek assistance may relapse due to continued withdrawal symptoms.
Although researchers are confident that Lucemyra will help some patients manage symptoms, there are some concerns. Participants experienced issues such as fainting during the trials.
The newly approved drug isn't a medication for opioid addiction, but is seen as a step toward helping some people begin medication-assisted treatment, seen as the gold standard of addiction care. There are several drugs on the market that can be used to treat the overall disorder, but some of them are hard to access.