Acura Pharmaceuticals, Inc. announced that the LTX-03 (hydrocodone bitartrate with acetaminophen) tablets using Acura’s LIMITx technology manufactured in the three New Drug Application (NDA) required registration batches, passed testing at the eighteen month time point in an ongoing shelf life study when stored at normal temperature and humidity conditions, also known as controlled room temperature (CRT). The patented LIMITx technology is a composition of 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. A known hydrocodone derivative continues to be detected in the CRT samples, as well as, unknown impurities.

The unknown impurities remain at levels within standards typically accepted by the Food and Drug Administration (FDA) for such impurities but the levels have increased since the twelve month analysis. The company intend to continue the shelf life study with the CRT samples as previously planned. The LTX-03 tablets were produced at the commercial contract manufacturer, in the to-be-marketed formulation, at commercial (equipment and process) scale.

The data being generated in the shelf life study is intended to be used to support the manufacturing and shelf life requirements for an NDA. FDA Guidance allows for the use of CRT data to establish shelf life standards for a product.