Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.US WorldMeds has completed the Phase III clinical trial investigating the use of lofexidine hydrochloride for the treatment of opiate withdrawal symptoms in patients undergoing opiate detoxification.
Subscribe to our email newsletter
The initial results demonstrate Lofexidine’s statistical significance versus placebo in reducing withdrawal symptoms associated with opiate detoxification on the third day of treatment, which is the expected peak point for withdrawal symptoms. Also, patients taking Lofexidine in the trial stayed in detoxification treatment longer than patients taking placebo.
Given the encouraging initial results of the Phase III clinical trial, US WorldMeds intends to submit a new drug application for Lofexidine with the FDA for US approval. The NDA will be filed after the complete dataset from the trial, including additional efficacy and safety measures, is analyzed, and additional required studies are completed.
If approved by the FDA, Lofexidine would be the first non-addictive, non-narcotic treatment approved in the US for relieving withdrawal symptoms associated with opiate detoxification.