December 9, 2013 / 11:51 AM / 4 years ago

Acura says FDA to review data from failed painkiller trial, shares jump

Dec 9 (Reuters) - Acura Pharmaceuticals Inc said the U.S. Food and Drug Administration agreed to review the results of a failed mid-stage trial of a painkiller made with the company’s technology designed to deter abuse.

Acura shares jumped 24 percent in premarket trade.

Results from the mid-stage trial showed in August that Acura’s tablet, being tested for potential abuse by snorting, did not significantly reduce likability among abusers.

Acura said on Monday that FDA agreed to provide a definitive response regarding the suitability of the trial to be considered in an approval application review.

The regulator also asked for some additional data, but the company said it does not expect to conduct additional studies to provide the information.

Acura shares were trading at $2.08 before the bell. They closed at $1.69 on the Nasdaq on Friday. (Reporting by Esha Dey in Bangalore; 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