Pink Sheet is part 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

Silenor "Complete Response" Letter Hints At Efficacy Issues

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Somaxon's last-minute conference call announcing FDA's "complete response" letter for the insomnia agent Silenor (doxepin) did little to clarify whether the agency's concerns have to do with efficacy issues or whether FDA just wants more data on doxepin's potential to prolong the QT interval. Somaxon announced the action letter late on Feb. 26

You may also be interested in...



Somaxon’s Silenor Could Launch In Early ’09 Pending Partnering Discussions

Somaxon submits an NDA for the insomnia medication, setting it up for potential FDA approval in December, firm tells "The Pink Sheet" DAILY.

Somaxon Could Fold Gambling Drug Development Following Negative Trial Results

Company will also assess results of nalmefene studies in smoking cessation before deciding on drug’s future.

Myovant’s Relugolix Won’t Be Stopped By Missed Endpoint

The miss on improving castration resistance-free survival in Phase III trial is not likely to affect the ongoing FDA review, the company and analysts agree.

Topics

UsernamePublicRestriction

Register

OM004674

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