KEYTRUDA plus Padcev improves survival for bladder cancer patients
PALATINE, IL - Acura Pharmaceuticals, Inc. (OTC Market:ACUR), a specialty pharmaceutical company with a market capitalization of $1.33 million engaged in the research, development, and commercialization of products intended to address medication abuse and misuse, announced significant progress in the development of its drug candidate LTX-03. The company has shown remarkable market performance, with a staggering 9,900% year-to-date return according to InvestingPro data. The company, along with its development partner Abuse Deterrent Pharma, LLC, held a meeting with the U.S. Food and Drug Administration (FDA) on May 15, 2025, to discuss the advancement of LTX-03 towards a New Drug Application (NDA) submission.
LTX-03, which utilizes Acura’s LIMITx technology, aims to mitigate the risks associated with opioid overdose. The technology is designed to reduce the peak blood concentration of hydrocodone when multiple tablets are ingested. During the meeting, the FDA was receptive to including the distinctive pharmacokinetic characteristics of LTX-03 in the final approved labeling. However, the FDA indicated that a label claim suggesting a lower risk of overdose would not be justified based on pharmacokinetic testing alone.
The company expects to conduct an additional human pharmacokinetic study, AP-LTX-310, comparing a single tablet dose of LTX-03 to an FDA Reference Standard drug in both fed and fasted states. InvestingPro analysis indicates the company’s stock has shown significant momentum, with a 899.5% price return over the past six months, though investors should note the stock’s historically high price volatility. This study is contingent on the production of new clinical supplies of LTX-03. Additionally, the FDA advised that the lower dosage strengths of LTX-03 would require scientific support in the NDA. Acura is considering whether to conduct a study for these strengths as part of the NDA submission or to add them post-approval.
LTX-03 combines hydrocodone with acetaminophen, one of the most prescribed opioid analgesics in the U.S. Acura aims to provide effective pain treatment with LTX-03 at recommended doses, while limiting the maximum blood level (Cmax) when higher doses are consumed. This is achieved by neutralizing stomach acid with buffering ingredients, which reduces the available acid to release and absorb the active ingredient from the LIMITx tablets.
The company’s forward-looking statements involve risks and uncertainties, including the ability to obtain funding, FDA acceptance of an NDA, potential termination of the license by the licensee, and the efficacy of LTX-03 in clinical studies and commercial settings. InvestingPro identifies several financial challenges, including weak gross profit margins and no dividend payments to shareholders. For deeper insights into the company’s financial health and additional ProTips, subscribers can access the full analysis on InvestingPro. Acura’s ability to commercialize its products, obtain necessary regulatory approvals, protect its patents, and successfully develop additional products using its technology are also subject to risks.
This announcement is based on a press release statement and contains forward-looking statements that are subject to risks and uncertainties. Investors are cautioned not to place undue reliance on these statements, which speak only as of the date of this report.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.