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Catalent and US WorldMeds have entered into an agreement for the commercial manufacture of lofexidine, a drug used to alleviate opioid withdrawal symptoms.
On Sept. 5, 2017, Catalent announced an agreement with US WorldMeds, a pharmaceutical company that develops, licenses, and markets healthcare products, for the commercial manufacture of lofexidine, an investigational drug under development to alleviate symptoms of opioid withdrawal and enable opioid discontinuation treatment.
US WorldMeds has the rights to commercialize the treatment in the United States. The drug is currently approved as Britlofex (lofexidine) in the United Kingdom. Catalent and US WorldMeds have worked together to tech-transfer the manufacturing from a facility overseas to Catalent’s Winchester, KY, facility, where Catalent has produced registration batches to support US WorldMeds’ new drug application to FDA and its commercial launch.
FDA has granted the drug fast track designation, a process designed to expedite the review of drugs that treat serious conditions and address an unmet medical need. If approved, lofexidine would be the first non-narcotic and non-addictive medication in the US for treatment of symptoms associated with opioid withdrawal, according to Catalent.