Acura Pharmaceuticals Provides an Update on the Development of LTX-03

PALATINE, Ill., March 23, 2020 (GLOBE NEWSWIRE) -- Acura Pharmaceuticals, Inc. (OTCQB: ACUR), today announced that Abuse Deterrent Pharma, LLC, its licensee of LTX-03 (Hydrocodone Bitartrate and Acetaminophen with Acura’s LIMITx™ Technology), has engaged Catalent Pharma Solutions, LLC (“Catalent”) to perform tablet manufacturing for clinical testing supplies of the product.  Acura previously engaged Catalent to perform micro-particle process development for LTX-03 using hot-melt extrusion technology at Catalent’s Somerset, New Jersey facility before transferring to scaled production in Winchester, Kentucky, and which work is pending receipt of auxiliary manufacturing equipment expected in the next 30 days. Catalent is a leading provider of advanced delivery technologies, development and manufacturing solutions and has the expertise, technologies and scale to move products through development to commercialization.

LIMITx™ Technology is designed to retard the release of active drug ingredients when too many tablets are accidentally or purposefully ingested by neutralizing stomach acid with buffer ingredients, but to also deliver efficacious amounts of drug when taken as a single tablet with a nominal buffer dose. Acura’s clinical testing to date indicates a reduction in opioid peak drug concentration (Cmax) of up to 65% may be achieved in overdose situations and a study in an animal model demonstrated Cmax is associated with acute respiratory depression which increases the probability of death due to overdose.

There were 45,000 suicide deaths in the US in 2016.  Approximately 15% of these suicides are due to poisoning, which includes opioid overdosing. 

About Acura Pharmaceuticals
Acura Pharmaceuticals is a specialty pharmaceutical company engaged in the research, development and commercialization of technologies and product candidates intended to mitigate the risk of outcomes associated with product misuse.  The Company has three proprietary technologies: LIMITx™ Technology, AVERSION® Technology and IMPEDE® Technology. 

LIMITx™ Technology utilizes acid neutralizing ingredients to precisely control gastric acidity, which limits the release of drug from tablets and its subsequent systemic absorption when multiple tablets are ingested.  LIMITx™ Technology is useful with products whose side effect risks can be mitigated by limiting exposure to a drug in overdose situations.

AVERSION® Technology, used in the FDA approved drug OXAYDO® (oxycodone HCl) marketed by Zyla Life Sciences, utilizes polymers designed to limit the abuse of the product by nasal snorting and injection.  AVERSION® Technology is also licensed to Kempharm for use in certain of their products.

IMPEDE® Technology, used in NEXAFED® (pseudoephedrine HCl) and NEXAFED® Sinus (pseudoephedrine HCl/acetaminophen) marketed by MainPointe Pharmaceuticals, utilizes polymers and other ingredients to disrupt the extraction and processing of pseudoephedrine from the tablets into methamphetamine.

About Catalent
Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs over 13,000 people, including approximately 2,400 scientists and technicians, at more than 35 facilities, and in fiscal year 2019 generated over $2.5 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com

More products. Better treatments. Reliably supplied.™

Forward-Looking Statements
Certain statements in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995.  Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements.  Forward-looking statements may include, but are not limited to:

• our ability to fund or obtain funding for our continuing operations, including the development of our products utilizing our LIMITx™ and IMPEDE® Technologies;
• whether our licensees will terminate the license prior to commercialization;
• the expected results of clinical studies relating to LTX-03, IMPEDE® or any successor product candidate, the date by which such studies will complete and the results will be available and whether any product candidate will ultimately receive FDA approval;
• the ability of LTX-03 single tablets to achieve bioequivalence or to demonstrate efficacy in a clinical study;
• whether our licensing partners will exercise their options to additional products;
• whether LIMITx™ Technology will retard the release of opioid active ingredients as dose levels increase;
• whether the extent to which products formulated with the LIMITx™ Technology mitigate respiratory depression risk will be determined sufficient by the FDA;
• our and our licensee’s ability to successfully launch and commercialize our products and technologies;
• our and our licensee’s ability to obtain necessary regulatory approvals and commercialize products utilizing our technologies;
• the market acceptance of, timing of commercial launch and competitive environment for any of our products;
• our ability to develop and enter into additional license agreements for our product candidates using our technologies;
• the ability to avoid infringement of patents, trademarks and other proprietary rights of third parties;
• the ability of our patents to protect our products from generic competition and our ability to protect and enforce our patent rights in any paragraph IV patent infringement litigation;
• the adequacy of the development program for our product candidates, including whether additional clinical studies will be required to support an NDA and FDA approval of our product candidates;
• changes in regulatory requirements;
• adverse safety findings relating to our commercialized products or product candidates in development;
• whether or when we are able to obtain FDA approval of labeling for our product candidates for the proposed indications and whether we will be able to promote the features of our technologies; and
• whether our product candidates will ultimately perform as intended in commercial settings.

In some cases, you can identify forward-looking statements by terms such as "may," “will”, "should," "could," "would," "expects," "plans," "anticipates," "believes," "estimates," “indicates”, "projects," “predicts," "potential" and similar expressions intended to identify forward-looking statements.  These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties.  Given these uncertainties, you should not place undue reliance on these forward-looking statements.  We discuss many of these risks in greater detail in our filings with the Securities and Exchange Commission.

Contact:
for Acura Investor Relations
investors@acurapharm.com
847-705-7709