Close
CDMO Safety Testing 2026
Novotech

King Pharmaceuticals and Acura Pharmaceuticals Announce Submission of New Drug Application for ACUROX Tablets

Note* - All images used are for editorial and illustrative purposes only and may not originate from the original news provider or associated company.

Subscribe

- Never miss a story with notifications

- Gain full access to our premium content

- Browse free from any location or device.

Media Packs

Expand Your Reach With Our Customized Solutions Empowering Your Campaigns To Maximize Your Reach & Drive Real Results!

– Access the Media Pack Now

– Book a Conference Call

Leave Message for Us to Get Back

Related stories

Designing Biotech Financial Models for Series B Success

Building a compelling Series B case in biopharma goes well beyond efficacy data and market size projections. Sophisticated investors are increasingly focused on CMC risk, licensing obligations, and the defensibility of your manufacturing timeline. This article breaks down what the financial model behind a strong Series B actually looks like and what quietly kills deals that should have worked.

CMC Bottleneck in Drug Development and IND Delays

Ask any experienced biopharma program manager what derails an IND filing most often, and the answer is rarely surprising: it is CMC. Not insufficient efficacy data, not toxicology surprises CMC. This article examines why Chemistry, Manufacturing, and Controls continues to be the most underestimated risk in early drug development, and what program leaders can do about it.

The Hidden Cost of Licensing in Biologic Drug Development

Royalties, milestone payments, and license fees are often treated as the cost of doing business in biopharma. But for early-stage biotech companies building toward an IND, these obligations can quietly reshape financial models, complicate investor conversations, and create downstream deal terms that are difficult to unwind. Here is what founders need to know.
- Advertisement -

King Pharmaceuticals®, Inc. and Acura Pharmaceuticals, Inc. announced that King has submitted a New Drug Application (NDA) for ACUROX® (oxycodone HCl) Tablets to the U.S. 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.

About ACUROX® Tablets

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.
About Aversion® Technology

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.

About King Pharmaceuticals®, Inc.

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. King’s wholly-owned subsidiary, Alpharma, LLC, is also a leader in the development, registration, manufacture, and marketing of pharmaceutical products for food-producing animals. On October 11, 2010, King entered into an agreement and plan of merger with Pfizer Inc. pursuant to which Pfizer agreed to commence a tender offer to purchase all of the outstanding shares of common stock of King for $14.25 per share net to the seller in cash. The tender offer is ongoing.

About Acura Pharmaceuticals, Inc.

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. Acura entered into a License, Development and Commercialization Agreement with King Pharmaceuticals®, Inc., in October 2007 pursuant to which Acura and King are now jointly developing ACUROX® Tablets and three additional opioid analgesic product candidates utilizing Aversion® Technology.

Latest stories

Related stories

Designing Biotech Financial Models for Series B Success

Building a compelling Series B case in biopharma goes well beyond efficacy data and market size projections. Sophisticated investors are increasingly focused on CMC risk, licensing obligations, and the defensibility of your manufacturing timeline. This article breaks down what the financial model behind a strong Series B actually looks like and what quietly kills deals that should have worked.

CMC Bottleneck in Drug Development and IND Delays

Ask any experienced biopharma program manager what derails an IND filing most often, and the answer is rarely surprising: it is CMC. Not insufficient efficacy data, not toxicology surprises CMC. This article examines why Chemistry, Manufacturing, and Controls continues to be the most underestimated risk in early drug development, and what program leaders can do about it.

The Hidden Cost of Licensing in Biologic Drug Development

Royalties, milestone payments, and license fees are often treated as the cost of doing business in biopharma. But for early-stage biotech companies building toward an IND, these obligations can quietly reshape financial models, complicate investor conversations, and create downstream deal terms that are difficult to unwind. Here is what founders need to know.

Early Phase Decisions Drive Faster Drug Development

Strategic early-stage planning and rigorous regulatory readiness serve as the foundation for accelerating pharmaceutical timelines and optimizing long-term R&D efficiency.

Subscribe

- Never miss a story with notifications

- Gain full access to our premium content

- Browse free from any location or device.

Media Packs

Expand Your Reach With Our Customized Solutions Empowering Your Campaigns To Maximize Your Reach & Drive Real Results!

– Access theMedia Pack Now

– Book a Conference Call

Leave Message for Us to Get Back

Translate »