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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.™
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