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

CV Outcomes Trials: FDA Actions, Announcements Paint Conflicted Picture

This article was originally published in The Pink Sheet Daily

Executive Summary

Policy of continuing safety trials into the post-approval setting gets favorable description in FDA meeting announcement, but delay of Contrave application suggests Orexigen may need to launch a new trial.

You may also be interested in...



CV Trials For Symptomatic Conditions Feasible But Not Always Practical, FDA Panel Says

FDA committee members generally reject the notion that dedicated safety studies are not possible for peripherally active mu opioid receptor antagonists in chronic pain patients, but acknowledge a low background cardiovascular risk and symptomatic nature of opioid-induced constipation make such trials problematic. The advisors’ opinions on the practicality of such trials in low-risk patients with symptomatic conditions could have implications beyond PAMORAs.

Orexigen’s Big Plans On Hold As FDA Hashes Out Post-Marketing Requirements

Weight loss drug Contrave delayed by three months while sponsor and agency discuss how to handle data transparency for ongoing cardiovascular outcomes trial.

Orexigen Hopes FDA Sees The LIGHT On Contrave NDA

Contrave could be approved by FDA in 2014, making it the third obesity therapeutic to reach the market in the last two years. An interim analysis of the CV outcomes study LIGHT demonstrates a favorable risk-benefit profile, management said.

Topics

Related Companies

UsernamePublicRestriction

Register

PS077431

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