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Defining 'Substantial Efficacy': Post Hoc Analysis OK (When US FDA Does It)

 
• By Sue Sutter

The US Food and Drug Administration's approach to weighing "non-positive" efficacy data against the results from two successful clinical trials for an antidepressant drew protests from some members of its Psychopharmacologic Drugs Advisory Committee on Dec. 1. The development could have implications beyond antidepressant drug development and highlights the potential need for FDA guidance on this issue.

The US Food and Drug Administration's approach to weighing "non-positive" efficacy data against the results from two successful clinical trials for an antidepressant drew protests from some members of its Psychopharmacologic Drugs Advisory Committee on Dec. 1. The development could have implications beyond antidepressant drug development and highlights the potential need for FDA guidance on this issue.

The matter relates to Fabre-Kramer Pharmaceuticals Inc.'s antidepressant Travivo (gepirone extended-release) for which FDA reviewers conducted a post hoc analysis of four unsuccessful, active-controlled, gepirone trials using an endpoint that...

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Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 
• By Neena Brizmohun

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Nielsen Hobbs

This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Nielsen Hobbs

We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.

Brazil Pilots Digital Drug Pack Inserts

 
• By Francesca Bruce

A new pilot aims to take Brazil closer to ‘digital transformation.’

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Non-User Fee Dollars Increased In US FDA’s Updated FY 2026 Budget Request

 
• By Derrick Gingery

The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.

US ‘Most Favored Nation’ Pricing Could be Game Changer for Drug Access In Germany

 
• By Francesca Bruce

In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.

ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
• By Vibha Sharma

The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.