FDA approves Lucemyra for opioid withdrawal.

FDA Approves Lucemyra for Opioid Withdrawal

This Wednesday, the first non-opioid medication for opioid withdrawal symptoms, Lucemyra, was approved by the U.S. Food and Drug Administration (FDA). Lucemyra has shown promising results in medical studies of individuals choosing to abruptly stop their opioid use. The FDA fast-tracked the approval of Lucemyra’s use for opiate withdrawal symptom management in hopes of combatting the rampant opioid epidemic that has swept our nation.

Users of opioids, regardless of whether they’re buying heroin off the streets or taking painkillers as prescribed by a physician, run the risk of becoming physically dependent due to the chemical nature of these substances. When someone has become physically addicted to opiates, withdrawal symptoms will occur if they take a smaller amount than they have been usually taking or try to stop altogether. These symptoms can be both physical and mental, including muscle aches, chills, sweating, runny nose, nausea, vomiting, diarrhea, sleep issues, anxiety, depression, agitation, and many more.

Lucemyra, US WorldMeds’ brand name version of lofexidine, is an alpha-2 adrenergic agonist medication taken orally that works to reduce the brain’s release of norepinephrine. Studies have found that similar medications such as clonidine, an alpha-2 noradrenergic, have helped with cutting down on the production of norepinephrine due to opioid withdrawal, but didn’t seem to have any effect over the other symptoms patients were experiencing.

The two randomized, double-blind clinical trials of Lucemyra yielded positive results! Either lofexidine or a placebo was administered to 866 physically opioid-dependent adults who decided to discontinue use of opiates. The Short Opiate Withdrawal Scale of Gossop (SOWS-Gossop) was used to quantify self-reported data from patients about whether they were experiencing opioid withdrawal symptoms mildly, moderately, severely, or even at all – the lower the score, the less severity of symptoms. More patients who were administered Lucemyra participated in the entire treatment period of the study and had lower SOWS-Gossop scores than those given a placebo.

Patients of the study who were given the lofexidine experienced side effects such as sleepiness, sedation, dizziness, slow heart rate, low blood pressure, and, in only a few cases, fainting. The FDA will be requiring US WorldMeds to conduct at least 15 more studies on adults, children, and animals to ensure safety as well as find other potential uses for the drug that could be beneficial to eradicating the opioid epidemic.

Scott Gottlieb, M.D., Commissioner of the FDA, spoke about opioid withdrawal and why it’s so important to keep developing new treatments like Lucemyra, “We know that the physical symptoms of opioid withdrawal can be one of the biggest barriers for patients seeking help and ultimately overcoming addiction. The fear of experiencing withdrawal symptoms often prevents those suffering from opioid addiction from seeking help. And those who seek assistance may relapse due to continued withdrawal symptoms.” Saying we need help can be a lot easier than actually going out and getting it because of the fear of detox; however, knowing that medically-supervised detoxification is available to us which can lessen the severity of withdrawal symptoms could allow more addicts to seek and receive the treatment we so desperately need and deserve.