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


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

Executive Summary

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.

You may also be interested in...

Waiting For Next Regulatory Shoe To Drop For Takeda's Gout Drug Uloric

FDA already issued a warning based on preliminary data from the CARES outcomes study, but now the final results of the confirmatory trial are in and show higher risk for cardiovascular death for Uloric compared with generic allopurinol.

CV Outcomes Trials: FDA Actions, Announcements Paint Conflicted Picture

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.

Relistor Can Be Approved For Chronic Pain Patients With Constipation, FDA Says

Agency grants Salix/Progenics’ appeal seeking a chronic use indication for the mu opioid receptor antagonist without the need for additional clinical data on cardiovascular safety pre-approval. Decision also bodes well for AstraZeneca’s Movantik, which has a September user fee deadline.

Related Content


Related Companies

Latest Headlines
See All



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