Acura Pharmaceuticals provides development update on drug
PALATINE - Acura Pharmaceuticals Inc. Monday said LTX-03 tablets, a drug it is developing that helps prevent overdoses, successfully passed testing at the six month time point in an ongoing shelf life study when stored at normal temperature and humidity conditions.
LTX-03 is a hydrocodone bitartrate and acetaminophen tablet with inactive ingredients formulated in a manner that reduces the risks of drug overdose by reducing peak drug levels when inappropriate numbers of tablets are ingested.
When stored at high temperature and humidity, also known as accelerated conditions, the six month tests revealed the presence of a known derivative of hydrocodone at levels requiring further testing, Acura said.
The shelf life studies are required as part of the Food and Drug Administration approval process for new drugs.