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BRIEF-FDA staff raise concerns about Allergan, Serenity Pharma urinary drug

Oct 17 U.S. FDA -

* FDA staff says 1.5 mcg dose of Allergan's Nocturia drug met efficacy criteria, but clinical meaningfulness of dose is unclear compared to placebo

* FDA staff says of five deaths in clinical trials of drug, the role of drug cannot be definitively ruled out for two deaths

* FDA staff says the proposed dosing regimen for drug has not been studied in any clinical trials Source text - (bit.ly/2dIxcrs)

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