Acura Pharma Provides Updatye On Lumitx

Acura Pharmaceuticals, Inc. ACUR, a specialty pharmaceutical company innovating abuse deterrent drugs, today announced that's it is advancing its lead LIMITX™ oral abuse deterrent drug candidate using the opioid hydromorphone HCl (LIMITX Hydromorphone) into clinical testing. LIMITX is designed to retard the release of its active ingredient as more and more tablets are orally consumed. The Company expects to submit an Investigational New Drug Application (IND) with the US Food and Drug Administration (FDA) before the end of 2015. Unless questioned by the FDA, the IND will become effective 30-days after submission and the Company will be eligible to commence clinical testing. The initial clinical trial proposed for LIMITX Hydromorphone, 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 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 LIMITX Hydromorphone and DILAUDID brand of hydromorphone HCl. The objective of Cohort 1 will be to determine if the LIMITX Hydromorphone 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 LIMITX Hydromorphone 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 LIMITX Hydromorphone 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 the LIMITX Hydromorphone tablets is retarded as the dose level increases to abusive levels. A safety assessment of LIMITX Hydromorphone 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. "Study AP-LTX-400 will be a tremendous milestone in the development of the LIMITX Technology," said Dr. Al Brzeczko, Acura's Vice President of Technical Affairs and co-inventor of the LIMITX Technology. "We expect to gain insight into how LIMITX works in patients and have designed the study to guide us to adjusting the formulation if needed." Bob Jones, Acura's President and CEO added, "Acura is excited to be advancing our third abuse deterrent technology into clinical testing. If successful, we believe the oral abuse deterrent capabilities of LIMITX will mark a significant advancement in the field of opioid abuse deterrence." LIMITX Hydromorphone is being developed in part with a grant from the National Institute on Drug Abuse (NIDA). NIDA is not responsible for the results of any of the research.