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Desmopressin Battle: Ferring Asks FDA To Reject Serenity's Nocturia Drug

Executive Summary

Serenity's SER120 should be held to the same efficacy standards as Ferring's Nocdurna, which the agency has declined to approve three times, citizen petition says.

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A Tale Of Two Desmopressins: Trial Design Gave Noctiva Advantage Over Nocdurna, US FDA Says

Serenity's Noctiva and Ferring's Nocdurna both use desmopressin to treat nocturia, but Nocdurna has racked up three complete response letters while Noctiva was approved on the first try. US FDA explains how trial design and secondary endpoints influenced its decision in its denial of a Ferring citizen petition.

Allergan’s Nasal Spray For Frequent Nighttime Urination Gets Cautious Panel Nod

Desmopressin's limited efficacy over placebo doesn't dissuade FDA's advisory committee, which votes 14 to 4 in favor of approval even as many suggest indication be narrowed.

Allergan Nasal Spray For Frequent Nighttime Urination Faces Review Hurdles

Advisory committee will weigh in on desmopressin as FDA questions broad indication and says clinical meaningfulness of treatment effects for Serenity Pharmaceuticals/Allergan’s product vs. placebo are unclear.

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