Company Overview

Acura Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the research and development of technologies and products intended to address medication abuse and misuse.

The Centers for Disease Control and Prevention estimates that one person dies every 19 minutes from prescription drug abuse in the United States. For over a decade, Acura has been on the forefront of developing solutions to combat this epidemic, with products utilizing the Company’s proprietary abuse deterrent LIMITX, IMPEDE® and AVERSION® Technologies.

We have discovered and developed three proprietary platform technologies which can be used to develop multiple products. Our LIMITX and AVERSION® Technologies are intended to address methods of product tampering associated with opioid abuse while our IMPEDE® Technology is directed at minimizing the extraction and conversion of pseudoephedrine into methamphetamine.

  • Our 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 deliver efficacious amounts of drug when taken as a single tablet with a nominal buffer dose. We have completed two clinical studies of various product formulations utilizing immediate-release hydromorphone HCl and one clinical study using immediate-release hydrocodone bitartrate and acetaminophen. We plan to conduct another dose ranging study for immediate-release hydrocodone bitartrate and acetaminophen to commence in the fourth quarter of 2017, with topline results expected in the first quarter of 2018. The FDA has designated the development program for immediate-release hydromorphone HCl as Fast Track, which is designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. However, we intend to advance immediate-release hydrocodone bitartrate and acetaminophen as a lead LIMITX product candidate due to its larger market size and its known prevalence of oral excessive tablet abuse.
  • Our AVERSION® Technology incorporates gelling ingredients and irritants into tablets to discourage abuse by snorting and provide barriers to abuse by injection. AVERSION® is used in OXAYDO® Tablets (oxycodone HCl, CII), and is the first approved immediate-release oxycodone product in the United States with abuse deterrent labeling. We entered into a licensing agreement with Egalet Corporation for worldwide rights to manufacture and commercialize OXAYDO®. OXAYDO® is currently approved by the FDA for marketing in the United States in 5mg and 7.5mg strengths and was launched in the United States market in the third quarter of 2015.
  • Our IMPEDE® Technology is a proprietary mixture of inactive ingredients that prevents the extraction of pseudoephedrine, or PSE, from tablets using known extraction methods and disrupts the direct conversion of PSE from tablets into methamphetamine. IMPEDE® is used in NEXAFED® Tablets (30mg pseudoephedrine HCl) and NEXAFED® Sinus Pressure + Pain Tablets (30/325mg pseudoephedrine HCl and acetaminophen)and those NEXAFED® products were launched by us into the United States market in December 2012 and February 2015, respectively. We have multiple PSE products in development utilizing our IMPEDE® Technology. In March 2017 we entered into a licensing agreement with MainPointe Pharmaceuticals, LLC to exclusively market both NEXAFED® products in the United States and Canada.
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