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Acura to develop hydrocodone/APAP tablets using Limitx technology

US-based Acura Pharmaceuticals has started developing an immediate-release hydrocodone bitartrate with acetaminophen tablet (hydrocodone/APAP) incorporating its new LIMITX abuse deterrent technology.

Development of the LIMITX is currently being supported by a grant from the National Institute on Drug Abuse of the National Institutes of Health (NIH) to develop an immediate-release hydromorphone tablet.

The company intends to begin formulation development of the LIMITX hydrocodone/APAP tablet upon the conclusion of formulation optimization of the LIMITX hydromorphone product.

LIMITX is an early stage technology separate and apart from the company’s other abuse deterrent technologies, Aversion and Impede.

It is a new formulation of common pharmaceutical ingredients intended to address abuse by excess oral consumption of multiple tablets.

With over 135 million dispensed prescriptions in 2014 in the US, Hydrocodone/APAP is the largest prescribed opioid to treat moderate to severe pain.

Hydrocodone/APAP is also the single most abused prescription opioid, predominately by swallowing multiple tablets and LIMITX is specifically designed to address this route of abuse.

Currently, the company has patents pending with the US Patent and Trademark office covering its LIMITX technology.

Acura president and CEO Bob Jones said: "Based on the recent FDA Guidance as well as comments made by the former-FDA Commissioner at a March 2015 Appropriation Hearing, we believe the best course for Acura is to develop immediate-release acetaminophen combination opioids with our novel LIMITX technology."

Previously, the company had advanced the development of a hydrocodone/APAP product using its AVERSION technology, which was designed to deter nasal snorting, but intends to indefinitely suspend those efforts.