Acura Pharmaceuticals, Inc. reported that the LTX-03 (hydrocodone bitartrate and acetaminophen) tablets using Acura?s LIMITx technology manufactured in the three New Drug Application (NDA) required registration batches passed testing at the twenty-four month time point in an ongoing shelf life study when stored at normal temperature and humidity conditions, also known as controlled room temperature. 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 excessive numbers of tablets are ingested. Two known hydrocodone derivatives 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 eighteen month analysis. They 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 a NDA. FDA Guidance allows for the use of a minimum of 24 month CRT data to establish shelf life standards for a product. Recent reports suggest growing numbers of legitimate pain patients are going undertreated as they can no longer find doctors willing to treat them due to new prescribing guidelines associated with the opioid epidemic.

Suicide is increasingly seen as the only remedy for some of these patients through opioid overdose. They goal with LIMITx is to develop a treatment for effective pain relief at a one or two tablet dose while providing overdose protection by limiting high peak levels of drug in the bloodstream (Cmax) that can lead to respiratory depression and death when more than the recommended dose is ingested. LIMITx works by neutralizing stomach acid with buffering ingredients as increasing numbers of tablets are swallowed thereby reducing the stomach acid available to cause the release and subsequent systemic absorption of the active ingredient from micro-particles contained in the LIMITx tablets.

In a human clinical study, formulations of LTX-03 demonstrated, under fasted conditions, analgesic levels of hydrocodone in the blood when taken at a recommended one or two tablet dose but reduced the maximum blood level (Cmax) up to 30% when subjects were exposed to higher buffer ingredient levels. Hydrocodone with acetaminophen remains the single largest prescribed opioid in the U.S. with excess oral ingestion as the most prevalent method of misuse. Analysis of forensic data associated with hydrocodone overdose death suggests a typical consumption of approximately 16 immediate-release tablets, well within the number of tablets in an average filled opioid prescription.

The Company intends to demonstrate that a meaningful reduction in Cmax associated with oral overdose can mitigate the risk of respiratory depression and death. LTX-03 may offer safety advantages over existing opioid therapies consistent with the FDA?s recently proposed new guidelines for the approval of opioid products.