Acura Pharmaceuticals, Inc. announced 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 successfully passed testing at the six 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 high temperature and humidity, also known as accelerated conditions (“AC”), the six month tests revealed the presence of a known derivative of hydrocodone at levels requiring further testing.

This known derivative was also detected in the CRT samples and intermediate condition (“IC”) samples, those stored at temperatures and humidity between CRT and AC, at levels within normally accepted limits at this stage of development. The company intends to continue the shelf life study with the CRT and IC 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. Acura has completed its review of the Advice Letter received in October 2021 from the Food and Drug Administration (“FDA”) regarding proposed clinical study program for LTX-03. The company updated the three pharmacokinetic study protocols submitted to the FDA and drafted a fourth pharmacokinetic study protocol based on the Advice Letter.

These protocols have been provided to development and commercialization partner, Abuse Deterrent Pharmaceuticals, LLC (“AD Pharma”) for comment and determination of the timing of initiation of the studies. The new protocols will require submission to the FDA under the LTX-03 Investigational New Drug (“IND”) application before they can commence.