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

Opioid Withdrawal’s Potential CV Risk Drives Advisory Panel For Constipation Drugs

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA seeks advisory committee’s advice on whether cardiovascular outcomes trials for peripherally active mu opioid receptor antagonists should be required and the timing of any such studies.

You may also be interested in...



Naloxegol CV Safety Findings “Reassuring” – NEJM Study

AstraZeneca’s peripherally acting mu-opioid receptor antagonist was not associated with an increased incidence of major cardiovascular events in Phase III studies of chronic pain patients with opioid-induced constipation. An FDA advisory committee will review CV safety data for the drug class June 11-12.

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.

Clinical Trial Diversity Requires Sponsors Work With An Assortment Of Patient Advocates, Community Organizations

US FDA oncology officials are concerned that the entities sponsors are consulting in developing and implementing clinical trial diversity plans are not sufficiently diverse themselves and do not represent patients in underserved communities.

Topics

Related Companies

Related Deals

Latest Headlines
See All
UsernamePublicRestriction

Register

PS077414

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