Lucemyra is an oral, specific alpha 2-adrenergic receptor agonist that decreases the arrival of norepinephrine. It also does not stop patients from craving opioids.
FDA Commissioner Scott Gottlieb commented on the approval, saying, "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".
"The fear of experiencing withdrawal symptoms often prevents those suffering from opioid addiction from seeking help", Gottlieb said.
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. To prevent such symptoms, doctors typically recommend slow withdrawal from the drug, the FDA said. Adverse side effects included low blood pressure or symptoms such as lightheadedness, slow heart rate, dizziness, sleepiness, feeling faint at rest or when standing up, and dry mouth, said the release.
Opioid withdrawal incorporates indications for example - uneasiness, unsettling, rest issues, muscle hurts, runny nose, sweating, sickness, spewing, loose bowels and medication wanting - that happens in the wake of ceasing or lessening the utilization of opioids in anybody with physical reliance on opioids.
The FDA said that Lucemyra is only approved for up to 14 days. Compared to the placebo group, patients treated with Lucemyra reported a lower severity of symptoms. Lucemyra impacts the heart's electrical action, which can expand the danger of unusual heart rhythms.
The FDA said it would be requiring 15 postmarketing studies on lofexidine, "including both animal and human studies" to examine whether the drug could also be used in gradual opioid tapers and in pediatric patients, and also to better understand potential effects on blood pressure and hepatic function.
Clinical studies will be required to evaluate the safety in situations where use could be expected to exceed the maximum 14-day treatment period for which Lucemyra is now approved; to gather additional safety data on the effects of lofexidine on the liver; and to further characterize the effects on blood pressure after treatment is stopped.
Lofexidine had fast-track designation and was reviewed under the FDA's priority review process. The agency will also continue to evaluate how drugs now on the market are used, in both medical and illicit settings, and take regulatory action where needed. The new drug is expected to become available in the U.S.in August 2018.