Withdrawal symptoms from opioids are often very difficult to manage, but the approval of a new treatment could change all of that for patients.
What Drug Was Approved To Help Patients With Opioid Withdrawal Symptoms?
On May 16, the Food and Drug Administration (FDA) approved of the first non-opioid treatment for adults suffering from opioid withdrawal symptoms. The drug, called Lucemyra (lofexidine hydrochloride), will also help adults who rely on opioids for pain relief.
"As part of our commitment to support patients struggling with addiction, we're dedicated to encouraging innovative approaches to help mitigate the physiological challenges presented when patients discontinue opioids," said FDA Commissioner Scott Gottlieb, M.D. "The FDA will continue to encourage the innovation and development of therapies to help those suffering from opioid addiction transition to lives of sobriety, as well as address the unfortunate stigma that's sometimes associated with the use of medication-assisted treatments."
Common symptoms of opioid withdrawal include nausea, muscle cramping, agitation, anxiety, and opiate cravings. Patients can experience any combination of these symptoms after ceasing opioid use. The symptoms can inflict patients who are using opioids as instructed by a physician, and those patients who are addicted to it.
The FDA says that Lucemyra decreases the release of norepinephrine, a chemical that mobilizes the body for action. Scientists believe that this chemical greatly attributes to the majority of opioid withdrawal symptoms.
Patients usually manage withdrawal symptoms by switching the opioid with another medication or by using therapy.
How Did Researchers Test Lucemyra?
To test the drug, researchers conducted a pair of random clinical trials. 866 adults participated in the study. The participants all met the criteria for opioid dependence, and they were seeking treatment. Some patients received Lucemyra, and some patients received a placebo.
Each participant rated their symptom severity after taking the medication. Participants treated with Lucemyra experienced less withdrawal symptoms when compared to participants who took the placebo instead.
What Are The Causes For Concern With Lucemyra?
Although researchers are confident that Lucemyra will help some patients manage symptoms, there are some concerns. Common side effects include a slow heart rate, low blood pressure, and sleepiness. Participants experienced issues such as fainting during the trials.
The FDA said that Lucemyra is only approved for up to 14 days. It is not approved as a treatment for opioid use disorder. There are several drugs on the market that can be used to treat the overall disorder, but some of them are difficult to access.