Acura Pharmaceuticals, Inc. announced that the first clinical study for its investigational drug LTX-03 (hydrocodone bitartrate and acetaminophen) tablets using the company's LIMITx technology commenced enrollment. The study, AP-LTX-311 or Study 311, is designed to evaluate the levels of hydrocodone and acetaminophen in the blood plasma when taken at doses in excess of normal therapeutic doses. The LIMITx technology is designed to minimize risks associated with overdose by lowering the maximum drug concentration of hydrocodone in the blood as increasing numbers of tablets are ingested.

The Company expects topline results from Study 311 to be available in the second quarter of 2023. Study 311 is a phase 1 pharmacokinetic study in fasted healthy adult subjects who will be taking 2, 5 and 9 tablet doses. Study 311 is targeted to have 20 subjects complete all doses which will be administered in crossover fashion over a 4 week dosing period, with one week washout between doses.

All subjects will receive an intravenous naloxone blockade during drug administration to negate the pharmacologic effects of the opioid hydrocodone. The Company expects to compare the results from the LTX-03 doses to the known, well-characterized pharmacokinetic results for hydrocodone and acetaminophen from the published literature with the intent to demonstrate lower levels of hydrocodone exposure for LTX-03 compared to the currently marketed comparator product as increasing number of tablets are ingested. The acetaminophen active ingredient is not incorporated into the LIMITx technology in the LTX-03 tablet and is not expected to be substantially different from the comparator product.