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FDA Grants Priority Review for Opioid Withdrawal Treatment NDA

In clinical trials, lofexidine significantly reduced the severity of withdrawal symptoms

The U.S. Food and Drug Administration has granted priority review of the new drug application (NDA) for US WorldMeds’ lofexidine, an investigational treatment for opioid withdrawal.   During lofexidine’s development, the FDA granted it fast track status, a process designed to facilitate and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Lofexidine’s NDA submission is supported by two randomized, double-blind, placebo-controlled clinic...

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