Acura Pharmaceuticals has issued an update pertaining to the evolution of the much-anticipated LTX-03 tablets using technology called Acura LIMITx™ meant to curb risks linked with overdose of hydrocodone. Apparently, the manufacturing process and formulation for LTX-03 have been propelled for commercial scale in line with a third party formulation developer.

Partnered commercial manufacturers of Acura has reportedly received hydrocodone quota from the Drug Enforcement Administration and is in talks to acquire specific auxiliary equipment for the identified manufacturing process. In a bid to identify and assess the upsides of a decline in peak plasma drug concentration (Cmax) on opioid induced respiratory depression (OIRD), Acura has completed a non-clinical small animal study.

For the record, LIMITx™ technology has been designed to slow down the release of active drug ingredients when a slew of tablets is purposefully or accidentally ingested by neutralizing stomach acid     with buffer ingredients. The technology will help in delivering effective amount of drug when taken as a single tablet with a nominal buffer dose. Clinical testing of Acura alludes achievement of decline in opioid Cmax of up to 65% in overdose situations.

In all animals showing Opioid-induced respiratory depression, OIRD was palpable within 30 minutes of dosing that was consistent with the Cmax of the hydrocodone dose. Surged Cmax was normally linked with the rampant acute OIRD.

The company is of the opinion that the results of the study tend to underpin the growth of opioid products with a plunge in Cmax in overdose situations. It is worth mentioning that Acura is analyzing the results to decide if more non-clinical or clinical OIRD studies are required.

About Acura Pharmaceuticals

A specialty pharmaceutical company dedicated in the research, development and commercialization of products and technologies, Acura Pharmaceuticals, is a public company founded in 2003. The company addresses medication abuse and misuse.
 

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http://investors.acurapharm.com/news-releases/news-release-details/acura-pharmaceuticals-provides-update-development-ltx-03