On Mar. 23, 2020, Acura Pharmaceuticals announced that Abuse Deterrent Pharma, its licensee of LTX-03 (Hydrocodone Bitartrate and Acetaminophen with Acura’s LIMITx Technology), has engaged Catalent Pharma Solutions to perform tablet manufacturing for clinical testing supplies of the product.

Acura previously engaged Catalent to perform micro-particle process development for LTX-03 using hot-melt extrusion technology at Catalent’s Somerset, New Jersey facility before transferring to scaled production in Winchester, Kentucky, and which work is pending receipt of auxiliary manufacturing equipment expected in the next 30 days.

Catalent is a leading provider of advanced delivery technologies, development and manufacturing solutions and has the expertise, technologies and scale to move products through development to commercialization.

LIMITx™ Technology is designed to retard the release of active drug ingredients when too many tablets are accidentally or purposefully ingested by neutralizing stomach acid with buffer ingredients, but to also deliver efficacious amounts of drug when taken as a single tablet with a nominal buffer dose. Acura’s clinical testing to date indicates a reduction in opioid peak drug concentration (Cmax) of up to 65% may be achieved in overdose situations and a study in an animal model demonstrated Cmax is associated with acute respiratory depression which increases the probability of death due to overdose.

There were 45,000 suicide deaths in the US in 2016.  Approximately 15% of these suicides are due to poisoning, which includes opioid overdosing.