Acura Pharmaceuticals produces test pills
PALATINE -- Acura Pharmaceuticals Inc. Monday said it has produced three required registration batches of a safer pain relief drug for FDA testing.
The tablets from these batches will be used in a six-month shelf life stability study, which will commence immediately, and in several human clinical studies, which will commence after an update to the new drug application on file with the Food and Drug Administration, Acura said.
Acura's LTX-03 tablets are a formulation of hydrocodone with acetaminophen.
Acura said its goal is to develop a treatment for effective pain relief while providing overdose protection by limiting high peak levels of drug in the bloodstream, which can lead to respiratory depression and death when more than the recommended dose is ingested. It will work by neutralizing stomach acid with buffering ingredients as more tablets are swallowed, thereby reducing the stomach acid available to cause the release and subsequent systemic absorption of the active ingredient, the company said.