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Catalent to make opioid withdrawal candidate for US approval

By Flora Southey , 11-Sep-2017
Last updated on 11-Sep-2017 at 10:24 GMT2017-09-11T10:24:15Z


US WorldMeds has teamed up with Catalent Pharma Solutions to manufacture lofexidine, an investigational drug designed to treat symptoms associated with opioid withdrawal.

Under the agreement, Catalent’s Winchester, Kentucky-based facility will manufacture US WorldMeds’ lofexidine – currently approved as Britlofex in the UK – for commercialisation in the US.

New Jersey-headquartered Catalent said the candidate is designed to reduce opioid withdrawal symptoms and facilitate completion of opioid discontinuation treatment.

“If approved, lofexidine would be the first non-narcotic and non-addictive medication in the US for treatment of symptoms associated with opioid withdrawal,” said the firm.

VP of Marketing, Drug Delivery Solutions at Catalent, Aileen Ruff told us the firms have successfully transferred the technology into the facility. She added that the contractor has already produced registration batches to support US World Meds’ New Drug Application (NDA) to the US Food and Drug Administration (FDA).

Solid oral dose demand

According to Ruff, Catalent has observed an increased demand at its Winchester plant, where it makes oral solid-dose products.

“The site has seen significant growth due to increasing customer demand and Catalent has invested accordingly in technical expertise, capabilities and capacity,” she told us.

Ruff did not disclose details regarding the cost and method of manufacture.

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