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.
On October 13, 2016, Acura entered into a worldwide License Agreement with KemPharm Inc. in which we license our AVERSION® Technology to KemPharm for its use in the development and commercialization of three products using 2 of KemPharm’s prodrug candidates. KemPharm also has an option to extend the Agreement to cover two additional prodrug candidates. KemPharm is responsible for all development, manufacturing, and commercialization activities under this agreement although Acura may provide initial technical assistance where needed.
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 has developed for commercial sale NEXAFED®, a 30mg immediate-release formulation of pseudoephedrine hydrochloride and NEXAFED® Sinus Pain + Pressure, a 30mg immediate-release formulation with 325mg of acetaminophen. NEXAFED® was commercially available for sale in December 2012 and NEXAFED® Sinus Pressure + Pain was commercially available in February 2014. 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 March 17, 2017, Acura entered into a licensing agreement with MainPointe Pharmaceuticals granting them the authority to exclusively market both products in the United States and Canada. Prior to this date, we marketed these products on our own.
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.