On Wednesday, U.S. WorldMed’s Lucemyra became the first non-opioid therapy for the management of opioid withdrawal symptoms approved by the FDA.
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 FDA’s decision was supported by data gathered from two clinical studies that involved 866, clinically opioid-dependent adults, following abrupt discontinuation of use. Data from the Phase III study revealed that those treated with Lucemyra showed a significant reduction in withdrawal symptoms and demonstrated a longer stay in detoxification treatment when compared to individuals in the placebo group.
The FDA noted that while Lucemyra can reduce withdrawal symptoms, it has not been confirmed to prevent them, and that the treatment should not continue beyond 14 days. Additionally, the therapy has not been approved to treat opioid use disorder, but is intended to be used as part of a long-term treatment plan for the condition.
(Source: U.S. WorldMeds, LLC)
Filed Under: Drug Discovery