November 2, 2018 / 5:48 PM / 15 days ago

AcelRx Pharma's opioid pain drug gets U.S. FDA nod

Nov 2 (Reuters) - The U.S. Food and Drug Administration on Friday approved AcelRx Pharmaceuticals Inc’s opioid-based pain treatment, a fast-acting pill.

The treatment is approved for moderate-to-severe pain in medically supervised settings such as emergencies and for use in post-operative patients.

The approval comes a year after the initial marketing application for the drug, Dsuvia, was rejected by the agency, which sought additional safety data and certain changes to ensure that the drug was administered properly.

"The medicine is restricted to use in certified medically-supervised health care settings ‒ such as hospitals, surgical centers and emergency departments ‒ for administration by a health care professional," FDA Commissioner Scott Gottlieb said here in a statement. (Reporting by Aakash Jagadeesh Babu and Manas Mishra in Bengaluru; Editing by Sriraj Kalluvila)

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