Profile: Acura Pharmaceuticals, Inc. (ACUR.O)

Acura Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in research, development and manufacture of product candidates providing abuse deterrent features and benefits utilizing its Aversion Technology. The Company’s Aversion Technology platform has been successfully utilized in developing multiple opioid analgesic products candidates. Its portfolio of product candidates includes opioid analgesics to relieve pain while simultaneously discouraging common methods of pharmaceutical product misuse and abuse, including intravenous injection of dissolved tablets or capsules; nasal snorting of crushed tablets or capsules, and intentional swallowing of excess quantities of tablets or capsules. Acurox is an orally administered immediate release tablet containing oxycodone HCl as its sole active analgesic ingredient. On December 30, 2008, the Company submitted a 505(b) (2) new drug application (NDA) for Acurox Tablets to the United States Food and Drug Administration (FDA), including a request for priority review.

Aversion Technology is a platform technology providing abuse deterrent features and benefits to orally administered pharmaceutical drug products containing potentially abuseable active ingredients. The company focuses to utilize its Aversion Technology with opioid analgesics administered in tablet or capsule form. Aversion Technology opioid analgesic product candidates include a composition of commonly used active and inactive pharmaceutical ingredients. The Company conducts research, development, laboratory, manufacturing, and warehousing activities at its operations facility in Culver, Indiana and lease an administrative office in Palatine, Illinois. In addition to internal capabilities and activities, the Company engages numerous clinical research organizations (CROs) with expertise in regulatory affairs, clinical trial design and monitoring, clinical data management, biostatistics, medical writing, laboratory testing and related services. Such CROs perform, under its direction, development and regulatory services relating to its Aversion Technology product candidates.