Acura Earns Accolades from Frost & Sullivan for Developing a Novel Technology Platform to Prevent the Abuse of Opioid-based Medication through Oral Administration

Limitx™ has the potential to become an industry standard and prompt other manufacturers to upgrade their existing abuse-deterrent technologies

Nov 09, 2015, 07:00 ET from Frost & Sullivan

MOUNTAIN VIEW, Calif., Nov. 9, 2015 /PRNewswire/ -- Based on its recent analysis of the opioid oral abuse deterrence market, Frost & Sullivan recognizes Acura Pharmaceuticals, Inc. (Acura) (Nasdaq: ACUR), with the 2015 North American Frost & Sullivan Award for Technology Innovation. Acura's development of the Limitx™ technology may go a long way in helping curb opioid abuse and prevent overdose and addiction. The Company is supported by a grant from the National Institutes of Health (NIH) in developing this novel technology.

The Centers for Disease Control and Prevention terms drug abuse an epidemic as it affects millions worldwide. Acura is combating this menace with Limitx™. Laboratory tests conducted by Acura have confirmed the ability of Limitx™ to restrict the immediate release of the active pharmaceutical ingredient (API) into simulated gastric fluid when multiple tablets are consumed at once, either intentionally or accidentally.

"Limitx™ supersedes existing formulations that are incorporated in immediate-release opioid prescription pain killers," said Frost & Sullivan Research Analyst Karan Verma. "The lack of other abuse-deterrent products in the market that focus on oral abuse makes the Limitx™ technology unique and visionary."

The National Institute on Drug Abuse (NIDA) from the NIH has awarded a $300,000 grant to Acura for the Phase I development of Limitx™ to optimize the formulation and make it ready for human testing. Additionally, interest from the FDA and NIH for oral abuse deterrent formulations is likely to encourage the creation of similar technologies and formulations by other manufacturers.

Acura plans to employ the Limitx™ technology in other opioids to expand its product portfolio. For instance, it is formulating Limitx™ using hydromorphone as its sole active ingredient. Hydromorphone is an opioid that is administered to patients with moderate to severe pain. Acura is also testing immediate-release hydrocodone bitartrate with acetaminophen (hydrocodone/APAP) tablets on the Limitx™ platform. With more than 135 million prescriptions dispensed in 2014 in the United States alone, hydrocodone/APAP is the most commonly prescribed opioid for pain management as well as the most commonly abused prescription opioid through excess oral consumption. Using Limitx™, Acura is expected to prevent the oral abuse of both these opioids and simultaneously enhance their functionality.

"One of the areas of focus for Acura is technology scalability. Through its proprietary Aversion® Technology platform, it has formulated multiple abuse-deterrent analgesic opioids that cannot be easily crushed and snorted or injected into the body through a syringe," noted Verma. "It achieves this by employing an advanced hydrogel and polymer matrix drug delivery mechanism in its range of products. The effective scalability of its technology has allowed Acura to move on to its next-generation drug delivery platform, Limitx™."

Significantly, the Company experienced exceptional growth in 2015 with revenue of $5.4 million in the first quarter, compared to $42,000 for the first quarter of 2014, registering a net profit of $1.2 million. This growth was partly due to the licensing of one of the company's key products, Oxaydo™, to Egalet Corporation.

In the first quarter of 2015, Acura streamlined its focus on the Limitx™ platform. It has allocated $1 million to the invention of formulations based on this platform to test the feasibility of the technology on other APIs and to ascertain its safety and efficacy. The complete commercialization of products based on the Limitx™ platform is still three to five years away.

Each year, Frost & Sullivan presents this award to the company that has demonstrated uniqueness in developing and leveraging new technologies, which significantly impacts both the functionality and the customer value of the new products and applications. The award lauds the high R&D spend toward innovation, its relevance to the industry, and the positive impact on brand perception.

Frost & Sullivan Best Practices Awards recognize companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analysis and extensive secondary research to identify best practices in the industry.

About Acura Pharmaceuticals, Inc. (Acura)

Acura Pharmaceuticals is a specialty pharmaceutical company engaged in the research, development and commercialization of product candidates intended to address medication abuse and misuse, utilizing its proprietary LIMITX™, AVERSION® and IMPEDE® Technologies. LIMITX contains ingredients that are intended to reduce or limit the rate or extent of opioid release when multiple tablets are ingested. AVERSION contains polymers that cause the drug to gel when dissolved; it also contains compounds that irritate the nasal passages if the product is snorted. IMPEDE is designed to disrupt the processing of pseudoephedrine from tablets into methamphetamine.

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