Acura Pharmaceuticals, Inc.'s product candidate under a license, development and commercialization agreement with Abuse Deterrent Pharmaceuticals LLC, LTX-03 (hydrocodone bitartrate and acetaminophen) tablets using its LIMITx technology manufactured in the three New Drug Application (“NDA”) required registration batches, successfully passed testing at the twelve 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. When stored at higher temperature and humidity, also known as intermediate conditions (“IC”), the twelve month tests revealed the presence of a previously disclosed, known derivative of hydrocodone.

The IC samples also showed the presence of two as yet unidentified impurities at levels in excess of typical FDA standards for unknown impurities. The known hydrocodone derivative was also detected in the CRT samples. The unknown impurities were also detected in the CRT samples at levels within typically FDA accepted standards for such impurities.

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.