PALATINE, Ill., Sept. 09, 2019 (GLOBE NEWSWIRE) -- Acura Pharmaceuticals, Inc. (OTC Pink: ACUR), today announced that it has engaged Catalent Pharma Solutions, LLC (“Catalent”) to initiate manufacturing scale-up of LTX-03 (Hydrocodone Bitartrate and Acetaminophen) Tablets to ultimately be used in clinical testing. Formulation and manufacturing process optimization work being performed at a different laboratory is nearing completion. Catalent is a leading provider of pharmaceutical contract development and manufacturing services and has the expertise, technologies and scale to move products through development.
LIMITxTM 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 has completed four clinical studies of various product formulations utilizing the LIMITxTM Technology, which have demonstrated proof-of-concept for the LIMITxTM Technology and have identified the key components of its formulation for advancement to formal clinical testing.
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.
LIMITxTM 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. LIMITxTM 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 Egalet Corporation, 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.
Catalent is the leading global provider of advanced delivery technologies, development and manufacturing solutions for drugs, biologics, 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 nearly 13,000 people, including over 2,400 scientists, at more than 35 facilities across five continents, 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.™
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 LIMITxTM 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 LIMITxTM Technology will retard the release of opioid active ingredients as dose levels increase;
- whether the extent to which products formulated with the LIMITxTM 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.