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

 
• By Sue Sutter

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.

Cardiovascular outcomes trials may be feasible, but not necessarily practical, in a highly symptomatic patient population with a low background rate of events, FDA’s Anesthetic and Analgesic Drug Products Advisory Committee concluded in a recent two-day meeting on peripherally active mu opioid receptor antagonists (PAMORAs).

Through their majority vote recommending against CV outcomes trials for all drugs in the PAMORA class, committee members made clear...

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More from United States

Podium Policy Returns To US FDA, Or Is It Podcast Policy?

 
• By Michael McCaughan

US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.

US FDA’s Elsa AI Platform Is Not Guiding Regulatory Decisions, Official Says

 
• By Cathy Kelly

Tala Fakhouri said the agency’s use of the AI tool in the review process has generated lots of questions.

Branch Chief Vijay Kumar Named Acting Head Of US FDA’s Cell, Gene Therapy Office

 
• By Derrick Gingery

Kumar takes over as acting director of the Center for Biologics Evaluation and Research’s Office of Therapeutic Products days after director Nicole Verdun was ousted.

Recent And Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

More from North America

BIO Notebook: Policy Uncertainty Constraining Dealmaking

 
• By Mandy Jackson and Joseph Haas

Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.

Woodcock: Do Not Do The Wrong Study, Even If Against US FDA Advice

 
• By Sarah Karlin-Smith

The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.

AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA Says

 
• By Sue Sutter

Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.