PALATINE, IL--(Marketwired - February 01, 2016) - Acura Pharmaceuticals, Inc. (ACUR), a specialty pharmaceutical company innovating abuse deterrent drugs, today announced that clinical testing of its lead LIMITX™ oral abuse deterrent drug candidate using the opioid hydromorphone HCl (LTX-04) is allowed to proceed under an Investigational New Drug Application (IND) the Company filed with the Food and Drug Administration on December 30, 2015. LIMITX is designed to retard the release of the product’s active ingredient as more and more tablets are orally consumed thereby limiting peak blood concentrations of the opioid. The Company is in the process of manufacturing clinical trial materials and expects to commence enrollment in the first clinical study of LTX-04, Study AP-LTX-400, later in the first quarter of 2016.
Study AP-LTX-400, will be a Phase 1 exploratory pharmacokinetic study to evaluate the plasma absorption of hydromorphone from orally administered tablets in the fasted state. Study AP-LTX-400 will target to complete approximately 48 healthy subjects in two separate cohorts, with 24 subjects in each cohort. For safety, all subjects will receive a naltrexone block prior to and during dosing to blunt any serious adverse effects that may result from the doses of hydromorphone.
Subjects in Cohort 1 will be further randomized into three dosage groups taking either one, two or three 2mg hydromorphone tablets. Each Cohort 1 subject will take two different test formulations of LTX-04 and DILAUDID brand of hydromorphone HCl. The objective of Cohort 1 will be to determine if the LTX- 04 test products are delivering the appropriate amount of hydromorphone into the blood stream to treat pain. Additionally, Cohort 1 may begin assessing the extent that the release of hydromorphone active ingredient from the LTX-04 tablets is retarded as the dose level increases.
Following the results of Cohort 1, Cohort 2 subjects will be randomized into three dosage groups taking four, six or eight 2mg hydromorphone tablets. Each Cohort 2 subject will take one test formulation of LTX-04 selected based on the results of Cohort 1 and DILAUDID. The objective of Cohort 2 will be to further explore the extent the release of hydromorphone active ingredient from LTX-04 tablets is retarded as the dose level increases to abusive levels. A safety assessment of LTX-04 will be made from both study cohorts.
Acura expects topline study results from Study AP-LTX-400 to be available in the first half of 2016.
LTX-04 is being developed in part with a grant from the National Institute on Drug Abuse (NIDA). NIDA is not responsible for any research results.
About Acura Pharmaceuticals
Acura Pharmaceuticals is a specialty pharmaceutical company engaged in the research, development and commercialization of product candidates intended to address medication abuse and misuse, utilizing its proprietary LIMITX™, AVERSION® and IMPEDE® Technologies. LIMITX contains ingredients that are intended to reduce or limit the rate or extent of opioid release when multiple tablets are ingested. AVERSION contains polymers that cause the drug to gel when dissolved; it also contains compounds that irritate the nasal passages if the product is snorted. IMPEDE is designed to disrupt the processing of pseudoephedrine from tablets into methamphetamine.
OXAYDO® (oxycodone HCl immediate-release tablets) which incorporates the AVERSION Technology, is FDA approved and marketed in the U.S. by our partner Egalet Corporation.
Acura markets NEXAFED® and NEXAFED® Sinus, which are pseudoephedrine containing products that utilize the IMPEDE Technology.
