Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Allergan Nasal Spray For Frequent Nighttime Urination Faces Review Hurdles

Executive Summary

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.

You may also be interested in...



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

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.

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.

Ferring’s Nocdurna Nixed By FDA Panel, But Gets Multiple Paths Forward

Advisory committee members recommend Ferring conduct new pre-approval study to demonstrate clinical meaningful benefit of nocturia treatment, offering up variety of possible study designs.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

ID1132298

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel