Acura’s lead product, OXECTA® (oxycodone HCI, USP) Tablets CII, or OXECTA®, was approved for marketing by the United States Food and Drug Administration (FDA) on June 17, 2011. OXECTA® 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.
OXECTA® is being manufactured and commercialized by Pfizer under our October 2007 license agreement with a subsidiary of Pfizer and was made commercially available by Pfizer beginning in January 2012.
Other AVERSION® Products in Development
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 NEXAFED®, an over-the-counter, or OTC, immediate-release pseudoephedrine HCl (PSE) tablet, utilizing the Company’s proprietary IMPEDE® Technology. PSE is a widely-used nasal decongestant available in many non-prescription and prescription cold, sinus and allergy products, including Johnson & Johnson’s Sudafed® product. Acura’s IMPEDE® Technology is a proprietary mixture of inactive ingredients designed to disrupt the extraction or direct conversion of PSE in tablets into methamphetamine.
Acura intends to introduce NEXAFED® into pharmacies either directly or through a distribution partnership.