Acura’s lead product, OXAYDO® (oxycodone HCI, USP) Tablets CII, was approved for marketing by the United States Food and Drug Administration (FDA) on June 17, 2011. OXAYDO® represents the first immediate-release oxycodone product approved by the FDA that applies Acura’s AVERSION® Technology. AVERSION® is a mixture of inactive ingredients incorporated into pharmaceutical tablets and capsules designed to address some common methods of product tampering.
On January 8, 2015, Acura entered into a licensing and collaboration agreement with Egalet US, Inc. and Egalet Ltd. granting them exclusive worldwide rights to commercialize OXAYDO®. On September 9, 2015 OXAYDO® was launched for commercial distribution in the United States.
Acura has developed several other tamper-resistant opioid products using AVERSION® Technology. The Company is currently considering commercialization opportunities for these products and product candidates.
Acura is currently marketing NEXAFED®, its own 30mg immediate-release formulation of pseudoephedrine hydrochloride and NEXAFED® Sinus Pain + Pressure, a 30mg immediate-release formulation with 325mg of acetaminophen. Both of these products utilize IMPEDE® Technology. Acura aims to develop a full line of immediate and sustained-release products utilizing the IMPEDE® Technology for commercialization in the United States.
On June 15, 2015, Acura entered into a license and development agreement with Bayer. This agreement grants Bayer an exclusive worldwide license to our IMPEDE® Technology for the development of an undisclosed methamphetamine resistant product that contains pseudoephedrine to be marketed in the United States. This agreement also provides the rights to negotiate a license IMPEDE® Technology for certain other products.
Acura also seeks to establish partnerships outside the United States for products using its IMPEDE® Technology.