Phase 2 Trial for Oral Nonopioid Pain Medication Cleared by FDA

The Food and Drug Administration cleared the Investigational New Drug (IND) application for MAX-001 (Maxona Pharmaceuticals, Malvern, PA), an investigational oral therapy being developed for the treatment of people with acute pain. The decision permits Maxona Pharmaceuticals to proceed with MAX-001-201, a randomized, controlled phase 2 clinical trial in the United States. The upcoming phase 2 trial is expected to provide randomized controlled data in acute postsurgical pain.

MAX-001 is a proprietary optimized extended-release formulation of nefopam, which Maxona Pharmaceuticals is developing as a non-opioid, non-NSAID prescription therapy for acute and chronic pain. Nefopam has been used as an analgesic outside the United States in oral and intravenous formulations and is described by the company as a triple monoamine reuptake inhibitor, with effects on norepinephrine, serotonin, and dopamine.

Development Highlights

• The phase 2 study will evaluate MAX-001 for acute pain, with first patient enrollment expected within the next few months.
• Maxona Pharmaceuticals previously completed the MAX-001-101 phase 1 trial, which investigated dose-proportional pharmacokinetics.
• In the phase 1 study, the company reported no serious adverse events, severe adverse events, or premature discontinuations related to adverse events.
• No concerning trends were reported in clinical laboratory measures, electrocardiograms, or vital signs.

Source

Maxona Pharmaceuticals. Maxona Pharmaceuticals receives FDA IND clearance for MAX-001 phase 2 acute pain clinical trial. PR Newswire. Published July 15, 2026. Accessed July 21, 2026. https://www.prnewswire.com/news-releases/maxona-pharmaceuticals-receives-fda-ind-clearance-for-max-001-phase-2-acute-pain-clinical-trial-302826239.html