Acura Pharmaceuticals, Inc. is a specialty pharmaceutical company developing and commercializing tamper-resistant products to combat 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 AVERSION® and LIMITX™ Technologies are intended to address methods of abuse associated with opioid analgesics while our IMPEDE® Technology is directed at minimizing the extraction and conversion of pseudoephedrine into methamphetamine.
OXAYDO® Tablets (oxycodone HCl, CII), which utilizes the AVERSION® Technology, is the first and only approved immediate-release oxycodone product in the United States with abuse deterrent labeling. We entered into a Collaboration and License Agreement with Egalet Corporation pursuant to which we exclusively licensed to Egalet 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 late in the third quarter of 2015.
NEXAFED® Tablets (30mg pseudoephedrine HCl) and NEXAFED® Sinus Pressure + Pain Tablets (30/325mg pseudoephedrine HCl and acetaminophen), utilizing the IMPEDE® Technology, were launched by us into the United States market in December 2012 and February 2015, respectively. We have multiple pseudoephedrine products in development utilizing our IMPEDE® Technology. On March 17, 2017, we entered into a licensing agreement with MainPointe Pharmaceuticals to exclusively market both NEXAFED® and NEXAFED® Sinus Pressure + Pain Tablets in the U.S. and Canada. MainPointe will also assume all manufacturing and commercialization activities from Acura for both products. On June 15, 2015, we and Bayer Healthcare LLC entered into a License and Development Agreement pursuant to which we granted Bayer an exclusive worldwide license to our IMPEDE® Technology for use in an undisclosed methamphetamine resistant pseudoephedrine-containing product and providing for the joint development of such product using our IMPEDE® Technology for the U.S. market.
Our third abuse deterrent technology, LIMITX™, is designed to retard the release of active drug ingredients when too many tablets are accidently or purposefully ingested. We have completed our first clinical study, Study AP-LTX-400, of our lead LIMITX™ immediate release oral abuse deterrent drug candidate using the opioid hydromorphone HCl (LTX-04). The FDA has designated the development program for LTX-04 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. On April 13, 2016 and June 8, 2016, we announced that top line interim results from cohorts 1 and 2, respectively, of Study 400 for one test formulation of LTX-04 successfully demonstrated the release of the active opioid ingredient was reduced when three or more tablets were ingested, but that additional formulation development will be required for LTX-04 to deliver a sufficient amount of the active ingredient when one or two tablets are administered. We are also developing an immediate-release hydrocodone bitartrate with acetaminophen product utilizing our LIMITX™ Technology.