91Ï㽶ÊÓƵ Pharma Solutions today announced it has entered into an exclusive agreement with US WorldMeds, LLC for the commercial manufacture of lofexidine
US WorldMeds has the rights to commercialize lofexidine in the U.S., which is currently approved as Britlofexâ„¢ in the United Kingdom. 91Ï㽶ÊÓƵ and US WorldMeds have worked together to successfully tech transfer the manufacturing from a facility overseas to 91Ï㽶ÊÓƵ’s Winchester, Kentucky, facility, where they have produced registration batches to support US WorldMeds’ New Drug Application to the 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 United States for treatment of symptoms associated with opioid withdrawal.
“Symptoms of opioid withdrawal can be a significant barrier in seeking help and breaking the cycle of dependence and addiction,†said Jonathan Arnold, 91Ï㽶ÊÓƵ’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.â€
91Ï㽶ÊÓƵ’s Winchester, facility has more than 20 years’ experience in product development, technology transfer and commercial manufacturing. The site has produced over three billion tablets and capsules annually and launched more than 100 new products into the market since its inception.
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About 91Ï㽶ÊÓƵ
91Ï㽶ÊÓƵ is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 90 years serving the industry, 91Ï㽶ÊÓƵ has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. 91Ï㽶ÊÓƵ employs approximately 10,000 people, including over 1,400 scientists, at more than 30 facilities across five continents, and in fiscal 2017 generated more than $2 billion in annual revenue. 91Ï㽶ÊÓƵ is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com