A Kentucky-based specialty pharmaceutical company hopes a $15 million federal grant and the seventh U.S-based trial of their medication to treat withdrawal symptoms associated with opioid dependence will pave the way to federal approval of the medication.
US World Meds announced this week that it is recruiting 600 patients from 13 sites for the Phase III clinical trial of lofexidine hydrochloride, a non-narcotic drug that has been used for some time in the United Kingdom for opioid detox under the brand name BritLofex. The company, which acquired a license for lofexidine from Brittania Pharmaceuticals a decade ago, has received a three-year, $15 million grant from the National Institute on Drug Abuse (NIDA) for the latest phase in its research.
“We are confident that this funding will allow us to generate the necessary data to secure regulatory approval which will provide access to an important, new treatment option for millions of Americans afflicted with opiate addiction,” US World Meds CEO P. Breckinridge “Breck” Jones said in a statement.
The company hopes this study will lead the way to a successful New Drug Application for lofexidine, which would make available in the U.S. the first non-addictive treatment to help patients manage opioid withdrawal symptoms such as vomiting, sweating and muscle pain.