Catalent enters into exclusive agreement for commercial manufacture of lofexidine

Global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, Catalent Pharma Solutions, has entered into a commercial manufacturing agreement with US WorldMeds for lofexidine.

Lofexidine is an investigational drug that is currently under development and has received fast track designation by the US Food and Drug Administration (FDA). It will be used to reduce symptoms associated with opioid withdrawal and assist in the completion of opioid discontinuation treatment.

Under the terms of the agreement, US WoldMeds will have the rights to commercialise lofexidine in the US. The drug is currently approved as Britlofex in the UK.

“Symptoms of opioid withdrawal can be a significant barrier in seeking help and breaking the cycle of dependence and addiction,” said Jonathan Arnold, Catalent's ‎vice president and general manager, Drug Delivery Solutions. “We are excited to join forces with US WorldMeds to bring a potential new treatment option to a major health issue spanning the nation.”

Both companies have worked together in bringing the manufacturing tech successfully from an overseas facility to Catalent’s Winchester, Kentucky site. Additionally, registration batches have been produced from the Kentucky facility, which have been used to support US WorldMeds new drug application to the FDA and the anticipated commercial launch.

If lofexidine is approved by the FDA it will become the first non-narcotic and non-addictive medication in the US for the treatment of symptoms associated with opioid withdrawal.