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

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

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

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.

You may also be interested in...



A New Dawn For Female Sex Dysfunction Drugs? FDA Meeting Cheers Sponsors

Experts convened by FDA to discuss female sexual dysfunction disorders, including problems with desire and arousal, settle on endpoints contrary to new DSM, but are in line with trials of Sprout’s flibanserin, the leading drug in development.

Sprout’s Female Desire Drug: Size Of Safety Studies Doesn’t Matter To FDA

Flibanserin development can move forward after dispute resolution, but women’s health advocates criticize the delay, charging that FDA has a double standard for female sexual dysfunction drugs.

Resurrected Flibanserin Filing Tests FDA Position On Female Sexual Desire Disorders

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.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS005885

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