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

Suvorexant’s Strike One: Higher Doses Out, More Low Dose Studies In

This article was originally published in The Pink Sheet Daily

Executive Summary

Merck’s “complete response” for insomnia drug suvorexant indicates FDA wants drug doses the company has said are ineffective.

You may also be interested in...



FDA, Merck Clash Over Value Of Subjective Insomnia Endpoints

Merck favors the subjective study endpoints, perhaps with an eye toward potential marketing challenges, and the Rozerem experience could haunt Merck’s dreams.

If Sponsors Don’t Ask, FDA Can’t Always Deliver: Merck’s Suvorexant Dosing Debacle

Sponsors may need to be more proactive in reaching out to the agency if they want to avoid the kind of dosing confusion currently facing Merck’s insomnia drug suvorexant, FDA indicates.

Insomnia Drug Development Programs Must Include Driving Studies, FDA Says

Agency will require driving simulation studies for all new sleep aids and is asking sponsors of currently approved products to conduct such trials. FDA is directing zolpidem-containing product manufacturers to make labeling changes based, in part, on driving data submitted for Transcept’s Intermezzo.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS075938

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