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

Women’s Intuition: What Approval Of Sprout’s Addyi Means For Sponsors

Executive Summary

Filing for a drug with questionable risk-benefit profile was saved by a trial protocol redesign, strict safety labeling for a narrow indication, a REMS, patient mobilization and plenty of postmarketing studies. Trial period echoes FDA’s approach with a similar sector of lifestyle drug: obesity.


Related Content

In Recommending Flibanserin Approval, FDA Panelists Urge Alcohol Contraindication
Sprout's Flibanserin Gets Reluctant Nod From FDA Panel, But REMS Needed
Flibanserin Risk Management Challenges: Can A REMS Prevent Alcohol Interactions?
A New Dawn For Female Sex Dysfunction Drugs? FDA Meeting Cheers Sponsors
Resurrected Flibanserin Filing Tests FDA Position On Female Sexual Desire Disorders
REMS For Qsymia Limits Distribution, But Vivus To Explore Expanding Access
FDA Approves Vivus’ Obesity Drug, Recommends Against Use In High-Risk Heart Patients


Related Companies