FDA Overlooks Red Flags in Janssen’s New Depression Medicine and Approve Anyway

concerning depression drug TrialsiteN

Spravato maker Janssen provided the FDA modest evidence that it worked and only in limited trials. It presented no information about the use of Spravato beyond 60 weeks. Why?

Key takeaways published originally by Kaiser Health News and picked up by HealthLeaders Media includes:

  • The expert panel cleared Spravato according to the evidence that the FDA and Janssen had determined was sufficient
  • 49 of the 227 people who participated in Janssen’s only successful efficacy trial had failed just one class of oral antidepressants
  • Three patients who received the drug died by suicide during the clinical trials; compared with none in the control group, raising red flags Janssen and the FDA dismissed.
  • Follow the link to read the rest of this fascinating story.  Why did the FDA push this drug through so quickly?