FDA clears new tool in fight against opioid epidemic
- The Food and Drug Administration gave a green light to the first non-opioid drug aimed at controlling the withdrawal symptoms associated with opioid use.
- Developed under private company US WorldMeds, Lucemyra works by diminishing the release of norepinephrine, a neurotransmitter that relays feelings of pain and affects withdrawal symptoms, research suggests.
- In late-stage testing, patients physically dependent on opioids who abruptly quit taking them reported less severe withdrawal symptoms when taking Lucemyra compared to placebo. There were safety signals, however, with some of the most common side effects from treatment being low blood pressure and slow heart rate. The drug can also elevate the risk of abnormal heart rhythms. More data is also needed to determine Lucemyra's safety and efficacy profile in patients younger than 17 years of age.
The national opioid epidemic has put a spotlight on the need for more treatments for pain, withdrawal symptoms and addiction.
Government agencies are trying to quickly usher new products to the market to address the need — but that hasn't panned out yet. Since last April, when the Department of Health and Human Services announced its five-point plan for tackling the opioid crisis, just one novel pain treatment has gained FDA approval: Flexion Therapeutics' Zilretta (triamcinolone acetonide extended-release), a non-opioid option for osteoarthritis knee pain.
Lucemyra (lofexidine hydrochloride), therefore, represents a win for both the agency and US WorldMeds, which has just a handful of marketed products. Notably, the application for Lucemyra received Priority Review and Fast Track designations.
In a May 16 announcement, the FDA stressed that Lucemyra isn't a treatment for opioid use disorder, but rather a potential tool for managing the disorder long-term. Even so, regulators see it as a valuable addition to pain management space, wherein those dealing with withdrawal frequently go untreated.
"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," the FDA said in a May 16 statement.
Lucemyra still has a sizable amount of R&D work ahead. The FDA mandated an additional 15 post-market studies of the drug, including more pre-clinical safety trials that will be necessary for label expansions. Now, the product is only approved for up to 14 days of treatment, and isn't for use in children. Regulators also want more data on the impact Lucemyra has on the liver.
Symptoms of opioid withdrawal vary. Some patients experience mental side effects like anxiety and agitation, while others have physical ailments like vomiting and drug craving. The FDA also points out that these symptoms can arise in patients who are taking opioid painkillers appropriately, as well as those with opioid use disorder.
"Lucemyra presents an important new tool to help people make it successfully through withdrawal, which is very often critical for linking to ongoing continuing care and next steps in treatment for opioid dependence or addiction," said Marc Fishman, medical director at Maryland Treatment Centers and assistant professor Johns Hopkins University School of Medicine, in a statement from US WorldMeds.
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