Catalent has deal to manufacture investigational opioid drug

By Lynda Cohen
Somerset | Sep 7, 2017 at 10:19 am

Somerset-based Catalent Pharma Solutions announced an agreement that will give it exclusive rights to commercially manufacture an investigational drug expected to help fight opioid addiction.

Lofexidine is being developed to lessen the symptoms of opioid withdrawal and help in treatment, and has been given “Fast Track” designation by the Food and Drug Administration. US WorldMeds has the rights to commercialize it in the United States.

“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 said in a statement.

It is currently available in the United Kingdom as BritlofexIf.

If approved in the U.S., it would be the first non-narcotic and nonaddictive medication in the nation to treat withdrawal symptoms.

Catalent and US WorldMeds have successfully tech transferred the manufacturing from a facility overseas to Catalent’s Winchester, Kentucky, facility.

That location has already produced registration batches to support the FDA application and the anticipated commercial launch.

“Symptoms of opioid withdrawal can be a significant barrier in seeking help and breaking the cycle of dependence and addiction,” the statement said.

Catalent’s Winchester facility has more than 20 years’ experience in product development, technology transfer and commercial manufacturing. The site has produced more than 3 billion tablets and capsules annually and launched more than 100 new products into the market since its inception.