US WORLDMEDS TO STUDY OPIATE WITHDRAWAL TREATMENT IN THE U.S.
US WorldMeds announced that it is enrolling patients in a Phase III clinical trial, USWM-001, investigating the use of lofexidine hydrochloride (Lofexidine) for the treatment of opiate withdrawal symptoms in opiate dependent individuals. If approved by the FDA, Lofexidine would be the first non-addictive, non-narcotic treatment for relieving the distressing withdrawal symptoms associated with opiate detoxification approved in the United States.
Investigators are currently recruiting 264 patients to participate in the in-patient, randomized, double-blind trial that will be conducted at 14 sites throughout the United States. The withdrawal treatment period will be eight days per patient. US WorldMeds expects the Phase III trial will support a new drug application filing with the FDA for Lofexidine for this indication.
Lofexidine, an alpha-2-adrenergic agonist, is the only non-addictive, non-opiate treatment approved in the UK to manage the often debilitating withdrawal symptoms that occur during opiate detoxification. Lofexidine has been used in an estimated 200,000 detoxifications over 13 years in the UK, where it is marketed by Britannia Pharmaceuticals as Britlofex.
Lofexidine has been studied in six prior clinical trials in the U.S. In 2003, the National Institute on Drug Abuse (NIDA) took the unusual step of stopping a similar Phase III trial when its data and safety monitoring board determined it unethical to continue administering placebo to research subjects in withdrawal in the face of lofexidine's overwhelming efficacy, according to US WorldMeds. NIDA is also playing a central role in the oversight of the company's latest clinical trial of lofexidine.
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