November 2, 2018 / 5:51 PM / 13 days ago

Trevena opioid painkiller fails to win FDA approval

Nov 2 (Reuters) - Trevena Inc said on Friday the U.S. Food and Drug Administration declined to approve its opioid injection for managing acute pain.

The widely expected rejection comes after a panel of experts voted against the approval of the drug, citing lack of safety data and the potential for abuse.

The FDA in its complete response letter requested additional clinical data and indicated that the safety data was not adequate for the proposed dosing.

Opioid addiction and overdose have become a serious public health crisis in the United States. The FDA has urged drugmakers to develop alternative medicines to opioid painkillers. (Reporting by Saumya Sibi Joseph in Bengaluru Editing by Saumyadeb Chakrabarty)

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below