Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Resurrected Flibanserin Filing Tests FDA Position On Female Sexual Desire Disorders

Executive Summary

With a decision by FDA on a new filing for flibanserin possible by the fall, Sprout hopes to gain the first U.S. approval for treating women with low sexual desire. Meanwhile, Palatin forges on to Phase III with its female sexual desire disorder drug bremelanotide after discussing endpoints with FDA.

You may also be interested in...



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

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.

Sprout’s Low Libido Drug Flibanserin Going To FDA Advisory Panel

Originally developed by Boehringer Ingelheim, serotonin agonist and antagonist flibanserin is in position to be the first FDA-approved drug for female sexual desire disorders.

Timing Better For Sprout’s Latest Shot At First Female Sex Desire Drug

Sprout’s flibanserin resubmission should have an easier time at FDA, as experts backed key aspects of trial design used in flibanserin studies and patients sought treatment options at last year’s workshop on female sexual dysfunction.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS055485

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