Pink Sheet is part of the Business Intelligence Division 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

Sage's Postpartum Depression Drug Brexanolone Faces Loss-Of-Consciousness Questions

Executive Summary

US FDA is recommending a REMS requiring continuous monitoring during the 60-hour infusion and no home use, a potential problem for commercial marketing.

Advertisement

Related Content

Janssen’s Esketamine: US FDA Panel To Weigh Efficacy, REMS Restrictions For Treatment-Resistant Depression
Sage Gets More Time For Zulresso Launch Preparations With Delay Of US FDA Approval
Sage May Be Forced To Simplify Brexanolone Dosing Regimen
US FDA's Internal Debate On Sage's Brexanolone Spills Into Open During Panel Review
Sage's Brexanolone Could Be Transformative, But Only In Controlled Settings, US FDA Panel Says
Recent And Upcoming FDA Advisory Committee Meetings
Can US FDA's Talk Therapy Cure What Ails Mental Health R&D?
User Fee Goal Dates

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register

PS124175

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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