FDA clears US WorldMeds' Lucemyra as first non-opioid treatment for opioid withdrawal

The FDA on Wednesday announced the approval of US WorldMed's Lucemyra (lofexidine) for the management of opioid withdrawal symptoms due to abrupt opioid discontinuation in adults. The agency noted that the drug is the first non-opioid therapy approved in the US for this indication. FDA Commissioner Scott Gottlieb stated "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 said that approval of Lucemyra was supported by safety and efficacy data from two clinical studies involving 866 adults meeting the clinical criteria for opioid dependence, following abrupt treatment discontinuation. In Phase III study data unveiled as far as 2008, the drug was associated with a significant reduction in withdrawal symptoms at the anticipated peak of withdrawal and longer stay in detoxification treatment versus placebo.  

FirstWord Reports: Providing insight, analysis and expert opinion on important Pharma trends and challenging issues <Click here>

The FDA cautioned that although the drug can reduce symptoms, it has not been proven to prevent them, adding that the treatment should not be continued beyond 14 days. The agency also noted that the therapy has not been approved for the treatment of opioid use disorder, although it can be used as part of a broader, longer-term treatment plan for the condition.  

The FDA noted that the submission was granted both priority review and fast track status. Approval of Lucemyra follows a positive vote backing authorisation of the therapy by an agency advisory panel in March. 

To read more Top Story articles, click here.