LIMITX™ Technology is intended to address an oral Excessive Tablet Abuse (ETA) or accidental consumption of multiple tablets and provide a margin of safety during accidental over-ingestion of tablets. LIMITX™ is also expected to exhibit barriers to abuse by snorting and injection.
In Study AP-LTX-400, a 60 subject human pharmacokinetic study, LTX-04P, our lead candidate demonstrated:
- a 20% reduction in maximum plasma concentration (Cmax) of active drug ingredient; and
- a 38% average reduction and 66% maximum reduction in Cmax in a subpopulation of subjects which had normal time to Cmax of 30 minutes of less.
LTX-04 is currently being reformulated to provide faster release of active ingredient when 1 and 2 tablets are ingested. The initial formulation of LTX-04 was supported by a grant from the National Institute On Drug Abuse of the National Institutes of Health under Award Number R44DA037921. The results and content of our research is solely the responsibility of Acura and does not necessarily represent the official views of the National Institutes of Health.
The need for abuse deterrent formulations which addresses excess oral consumption was stressed in the January 2013 FDA draft guidance for abuse deterrent opioids. In April 2015, the FDA issued Abuse-Deterrent Opioid Evaluation and Labeling Guidance. The LTX-04 development program is also designated as Fast Track by the FDA for its potential to address an unmet medical need.