Lucemyra is an oral medication that reduces the release of norepinephrine, which is believed to be associated with opioid withdrawal symptoms. But it can be used as part of a long-term plan for quitting the powerful painkillers and staying opioid-free long-term, the FDA said.
"We know that the physical symptoms of opioid withdrawal can be one of the biggest barriers for patients seeking help and ultimately overcoming addiction", said FDA Commissioner Scott Gottlieb, M.D., in a statement.
Patients usually manage withdrawal symptoms by switching the opioid with another medication or by using therapy.
Gottlieb said fear of withdrawal often discourages those with a physical dependence from seeking treatment, and the potentially intense symptoms often contribute to relapses.
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.
The FDA granted this application both priority review and fast track designations. In two randomized, double-blind, placebo-controlled trials, 866 adult patients demonstrated the benefits and safety of the drug. In its announcement, US WorldMeds explained that Lucemyra "suppresses the neurochemical surge that produces the acute and painful symptoms of opioid withdrawal".
Potential side effects include low blood pressure, slow heart rate, dizziness, sleepiness, fainting and dry mouth.
"Which is why patients may often not be able to go through the process without being an inpatient".
SOWS-Gossop scores were lower for patients treated with Lucemyra versus placebo and more patients in the Lucemyra group completed the treatment period. Lucemyra effect the heart's electrical activity, which can increase the risk of abnormal heart rhythms.
"There are many people who are physically dependent, meaning if you stop it, you're going to get withdrawal symptoms", but those people may not be to the point of negative social behavior, such as stealing things or ruining relationships, said Dr. Mark Pirner, senior medical director of Clinical Research and Medical Affairs for US WorldMeds.
An independent FDA advisory committee supported approving Lucemyra in March. In short, having sound, evidence-based information to inform prescribing can help ensure that patients aren't over prescribed these drugs; while at the same time also making sure that patients with appropriate needs for short and, in some cases, longer-term use of these medicines are not denied access to necessary treatments. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.