Catalent Pharma Solutions has announced it has entered an exclusive agreement with US WorldMeds for the commercial manufacture of lofexidine, 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 commercialise lofexidine in the US, which is currently approved as Britlofex™ in the United Kingdom. Catalent and US WorldMeds have worked together to successfully tech transfer the manufacturing from a facility overseas to Catalent’s facility in Winchester, Kentucky. There, the company has produced registration batches to support US WorldMeds’ new drug application (NDA) to the US Food and Drug Administration (FDA) and the anticipated commercial launch.
Lofexidine received fast track designation by the FDA, 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.
Catalent vice-president and general manager of drug delivery solutions said: "Symptoms of opioid withdrawal can be a significant barrier in seeking help and breaking the cycle of dependence and addiction.
"We are excited to join forces with US WorldMeds to bring a potential new treatment option to a major health issue spanning the nation."
Catalent’s Winchester facility has more than 20 years’ experience in product development, technology transfer, and commercial manufacturing. The site has produced more than three billion tablets and capsules annually and launched more than 100 new products into the market since its inception.