Catalent inks deal with US WorldMeds to manufacture opioid-withdrawal drug

Catalent has inked a deal to manufacture an opioid-withdrawal treatment for the U.S. market, pending FDA approval.

New Jersey-based CDMO Catalent signed a deal with Kentucky-based US WorldMeds to manufacture lofexidine, an investigational drug used to treat opioid withdrawal. Financial terms of the agreement were not released.

US WorldMeds is commercializing the drug, which is currently approved in the U.K. under the name Britlofex, in the U.S. Production of lofexidine has been tech transferred to Catalent’s Winchester, Kentucky, facility, where registration batches have been produced to support US WorldMeds’ NDA to the Food and Drug Administration.

“Symptoms of opioid withdrawal can be a significant barrier in seeking help and breaking the cycle of dependence and addiction,” Jonathan Arnold, Catalent's vice president and general manager for drug delivery solutions, said in a statement.

The FDA recently fast-tracked lofexidine. If approved, it would be the first non-narcotic and nonaddictive medication in the U.S. to treat symptoms associated with opioid withdrawal.

In 2013, Catalent began an estimated $35 million expansion at the Winchester facility that was to add about 80,000 square feet. But with additional investments in fluid bed capacity, the project ended up running to $52 million for an expansion of about 90,000 square feet, nearly double its original footprint.