Catalent Forms Commercial Mfg Pact

Catalent Pharma Solutions has signed a pact with US WorldMeds, a Louisville, Kentucky-headquartered specialty pharmaceutical company, for the commercial manufacture of US WorldMeds’ opioid-withdrawal drug, lofexidine.

Lofexidine is an investigational drug under development to mitigate symptoms associated with opioid withdrawal and facilitate completion of opioid discontinuation treatment.

US WorldMeds has the rights to commercialize lofexidine in the US, which is currently approved as Britlofex in the UK. Catalent and US WorldMeds have worked together to successfully tech transfer the manufacturing from a facility overseas to Catalent’s Winchester, Kentucky, facility, where they have produced registration batches to support US WorldMeds’ new drug application to the US Food and Drug Administration (FDA) and the anticipated commercial launch.

Lofexidine received fast-track designation by the FDA. If approved, lofexidine would be a non-narcotic and non-addictive medication in the US for treating symptoms associated with opioid withdrawal.

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