Acura Pharmaceuticals Holds FDA Meeting on LTX-03

An update from Acura Pharmaceuticals ( (ACUR) ) is now available.

On May 15, 2025, Acura Pharmaceuticals and its partner, Abuse Deterrent Pharma, LLC, held a second meeting with the FDA to discuss further development requirements for their drug candidate LTX-03, which uses Acura’s LIMITx technology. The FDA indicated that while LTX-03’s unique pharmacokinetic characteristics could be described in its labeling, a claim of lower overdose risk would require additional studies post-NDA approval. Acura plans to conduct a pharmacokinetic study to support the NDA submission, and is considering whether to include lower dosage strengths in the initial submission or add them later.

More about Acura Pharmaceuticals

Acura Pharmaceuticals, Inc. operates in the pharmaceutical industry, focusing on developing products that aim to deter drug abuse. The company utilizes its proprietary LIMITx technology to create formulations that manage drug release and absorption, primarily targeting opioid analgesics such as hydrocodone with acetaminophen.

Average Trading Volume: 8,025

Technical Sentiment Signal: Sell

Current Market Cap: $1.32M

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