MALVERN, PA — MAXONA Pharmaceuticals has taken a key step toward advancing its flagship pain therapy, filing an Investigational New Drug (IND) application with the U.S. Food and Drug Administration for MAX-001, a novel oral treatment for acute pain.
The company is positioning MAX-001 as a non-opioid, non-NSAID option for both acute and chronic pain, aiming to address growing demand for safer alternatives to traditional painkillers. Developed as an optimized extended-release formulation of nefopam—already prescribed abroad for moderate to severe pain—MAX-001 is designed to provide both rapid relief and sustained analgesic effects.
President and CEO Shawn Fatholahi credited the team’s efforts over the past six months, noting the company is ready to launch a Phase 2 trial pending FDA clearance. “With the submission of this IND, we are well positioned to accelerate development of MAX-001 and expand the options for safe and effective non-opioid analgesics,” Fatholahi said.
Phase 1 trial results released earlier this year showed MAX-001 was well tolerated, with no serious or severe adverse events, early discontinuations, or concerning findings in clinical labs, ECGs, or vital signs.
Robert Rubens, MD, MBA, FAAN, MAXONA’s clinical development lead, said the IND reflects extensive formulation work, pre-clinical studies, and a completed Phase 1 program that will be published later this year. The company expects the FDA’s decision will pave the way for mid-stage clinical testing as it seeks to broaden the pain management toolkit for healthcare providers.
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