Aug 15 Acura Pharmaceuticals Inc said
the U.S. Food and Drug Administration (FDA) indicated that the
company may have to conduct an additional study to determine the
abuse-deterrent capability of its experimental painkiller
The FDA in May said data was insufficient to support the
company's claim that the drug could not be abused by snorting.
The company said on Friday it would review data from a
previous trial to determine whether to proceed with an
additional clinical study.
Acura's drug, which contains common painkillers hydrocodone
bitartrate and acetaminophen, is designed to cause a burning
sensation when snorted or form a gelatinous mixture when
dissolved for injecting.
The drug failed in a mid-stage trial to show statistically
significant results in reducing likability among abusers by
snorting compared with the generic hydrocodone/acetaminophen
The FDA in December 2013 agreed to review the results of the
failed mid-stage trial.
Up to Thursday's close of 86.5 cents, Acura's stock had
nearly halved in value this year.
(Reporting by Anand Basu in Bangalore; Editing by Sriraj