King Pharmaceuticals, Inc. and Acura Pharmaceuticals, Inc. announced that King has submitted a New Drug Application (NDA) for Acurox (oxycodone HCl) tablets to the US Food and Drug Administration (FDA), including a request for priority review classification. Acurox is an immediate release tablet containing oxycodone HCl intended for the relief of moderate to severe pain. Acurox utilizes Acura’s patented Aversion Technology which is designed to deter opioid abuse by intravenous injection of dissolved tablets and nasal snorting of crushed tablets. Acurox does not contain niacin. A separate NDA submission for Acurox with Niacin Tablets is subject to an FDA Complete Response Letter. Further details on the response to this FDA action letter will be provided at a later date.
The FDA is expected to determine whether to accept the NDA for Acurox for filing and consider the priority review request within 60 days.
Acurox is a patented, orally administered, immediate release tablet containing oxycodone HCl as its sole active analgesic ingredient. Acurox utilizes Acura’s patented Aversion Technology, which is a composition of functional inactive ingredients designed to limit the abuse of dissolved or crushed tablets.
Aversion Technology is a patented composition of active and inactive ingredients intended to relieve moderate to severe pain and impede potential abuse via nasal snorting of crushed tablets and intravenous injection of dissolved tablets.
King, headquartered in Bristol, Tennessee, is a vertically integrated branded pharmaceutical company. King, an S&P 500 Index company, seeks to capitalize on opportunities in the pharmaceutical industry through the development, including through in-licensing arrangements and acquisitions, of novel branded prescription pharmaceutical products and technologies that complement the company’s focus in specialty-driven markets, particularly neuroscience and hospital.
Acura Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in research, development and manufacture of product candidates intended to provide abuse deterrent features and benefits utilizing the company’s proprietary Aversion and Impede Technologies, and other novel technologies.