PALATINE, Ill., March 01, 2022 (GLOBE NEWSWIRE) -- Acura Pharmaceuticals, Inc. (OTCQB: ACUR) today announced an amendment to its License, Development and Commercialization Agreement (“Agreement”)...
PALATINE, Ill., Feb. 14, 2022 (GLOBE NEWSWIRE) -- Acura Pharmaceuticals, Inc. (OTCQB: ACUR) today announced that the LTX-03 (hydrocodone bitartrate and acetaminophen) tablets using Acura’s LIMITx technology manufactured in the three New Drug Application (“NDA”) required registration batches successfully passed testing at the six month time point in an ongoing shelf life study when stored at normal temperature and humidity conditions, also known as controlled room temperature (“CRT”). The patented LIMITx technology is a composition of inactive ingredients formulated in a manner that reduces the risks of drug overdose by reducing peak drug levels when inappropriate numbers of tablets are ingested.
PALATINE, Ill., Aug. 16, 2021 (GLOBE NEWSWIRE) -- Acura Pharmaceuticals, Inc. (OTCQB: ACUR), an innovative drug delivery company engaged in the research, development and commercialization of technologies and products intended to address safe use of medications, announced today financial results for the three and six months ended June 30, 2021.
Acura Pharmaceuticals, Inc. (OTCQB: ACUR) today announced an amendment to its License, Development and Commercialization Agreement (“Agreement”) regarding Acura’s LIMITx™ LTX-03 product candidate with Abuse Deterrent Pharma, LLC (“AD Pharma”) to extend the FDA Acceptance Date for LTX-03 (“NDA Acceptance Date”) to February 28, 2022.
PALATINE, Ill., June 07, 2021 (GLOBE NEWSWIRE) -- Acura Pharmaceuticals, Inc. (OTCQB: ACUR) today announced the successful completion of three NDA required registration batches of the to-be-marketed LTX-03 formulation. The LTX-03 tablets were manufactured on commercial scale equipment and passed all requisite quality assurance tests. The LTX-03 tablets from these batches will be used in a six month shelf life stability study, which will commence immediately, and in human clinical studies, which will commence after an update to the Investigation New Drug application on file with the Food and Drug Administration (FDA).
PALATINE, Ill., Oct. 28, 2020 (GLOBE NEWSWIRE) -- Acura Pharmaceuticals, Inc. (OTCQB: ACUR) today announced an amendment to its License, Development and Commercialization Agreement (“Agreement”) regarding Acura’s LIMITx™ LTX-03 product candidate with Abuse Deterrent Pharmaceuticals, LLC (“AD Pharma”) to extend the FDA Acceptance Date for LTX-03 (“NDA Acceptance Date”), expand the product licenses, and revise the license payment schedule. Acura’s LIMITx™ technology, when applied to any pharmaceutical product, is designed to mitigate the adverse consequences associated with the overdose of tablets. The amended Agreement extends the NDA Acceptance Date to July 31, 2021, expands AD Pharma’s license to the LIMITx™ patents to LTX-02 (oxycodone/acetaminophen) and LTX-09 (alprazolam), and revises the license payments, effective as of May 2020, to $200,000 monthly running through July 2021.
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.
PALATINE, Ill., Jan. 02, 2020 (GLOBE NEWSWIRE) -- Acura Pharmaceuticals, Inc. (OTC Pink: ACUR), today provided an update on its development of LTX-03 (Hydrocodone Bitartrate and Acetaminophen) Tablets using Acura’s LIMITx™ technology intended to mitigate risks associated with overdose of the hydrocodone. In conjunction with a third party formulation developer, the formulation and manufacturing process for LTX-03 has been optimized for commercial scale. Acura’s partnered commercial manufacturer has received hydrocodone quota from the Drug Enforcement Administration and is in the process of acquiring specific auxiliary equipment for the identified manufacturing process. Acura has also completed a non-clinical small animal study to identify the benefits of a reduction in peak plasma drug concentrations (Cmax) on opioid induced respiratory depression (OIRD).
Acura Pharmaceuticals has engaged Catalent Pharma Solutions 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.
Bayer has pulled-out of a development and licensing deal for a pseudoephedrine containing product based on Acura Pharmaceuticals’ methamphetamine resistant technology, Impede.