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

Zelmac Pooled Study Results May Not Be Reflective Of Efficacy - FDA

Executive Summary

Pooling of efficacy data across three trials for Novartis' irritable bowel syndrome therapy Zelmac may not be appropriate because of mixed outcomes among the trials, FDA indicated in briefing documents prepared for the Gastrointestinal Drugs Advisory Committee meeting June 26.

You may also be interested in...



Latest Zelmac Trial Focuses On 12 Mg Dose In Women; Drug Is "Approvable"

Novartis' latest trial for the irritable bowel syndrome agent Zelmac focuses on a 12 mg daily dosing regimen in 1,500 females, with results to be submitted to FDA by the end of the year.

Latest Zelmac Trial Focuses On 12 Mg Dose In Women; Drug Is "Approvable"

Novartis' latest trial for the irritable bowel syndrome agent Zelmac focuses on a 12 mg daily dosing regimen in 1,500 females, with results to be submitted to FDA by the end of the year.

Novartis Zelmac Dosing Instructions Among Remaining Issues In FDA Review

FDA will have to decide between a high dose or titrated regimen for Novartis' irritable bowel syndrome therapy Zelmac following a review by the Gastrointestinal Drugs Advisory Committee.

UsernamePublicRestriction

Register

ID1132115

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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