MAXONA Pharmaceuticals announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for MAX-001, its lead compound targeting acute pain treatment. The submission represents a significant regulatory milestone for the company's non-opioid, non-NSAID oral therapy designed to address both acute and chronic pain conditions.
Novel Mechanism of Action
MAX-001 is being developed as a proprietary optimized extended-release formulation of nefopam, which has been extensively studied and widely prescribed outside the United States as a non-scheduled treatment for moderate to severe acute and chronic pain. The compound operates through a novel mechanism of action as a triple neurotransmitter re-uptake inhibitor, with relative potency greatest for norepinephrine reuptake inhibition, and reuptake inhibition of serotonin greater than dopamine.
"MAX-001 is designed specifically to deliver both a rapid onset and extended duration of analgesia," according to the company's announcement. When approved for use in the U.S., MAX-001 would be the only triple monoamine re-uptake inhibitor with an indication for the treatment of acute pain.
Positive Phase 1 Safety Profile
Earlier this year, MAXONA released Phase 1 clinical trial results demonstrating that MAX-001 was well tolerated across all study parameters. The trial showed no reported serious adverse events, early discontinuations due to related adverse events, or severe adverse events. Additionally, there were no concerning findings or abnormal trends in clinical laboratories, electrocardiograms, and vital signs.
"Our IND submission reflects our extensive formulation optimization work, comprehensive IND-enabling pre-clinical studies, and the results of the MAX-001 Phase 1 clinical program that was completed in Q1 2025 and will be published later this year," said Robert Rubens, MD, MBA, FAAN, Clinical Development lead for MAXONA Pharmaceuticals.
Development Progress and Next Steps
The IND submission marks the fourth significant development milestone for MAX-001 in 2025, demonstrating accelerated progress in the company's clinical development program. Shawn Fatholahi, President & CEO of MAXONA Pharmaceuticals, expressed confidence in the development trajectory.
"During the past six months, MAXONA has achieved a number of important MAX-001 development milestones," Fatholahi stated. "I am extremely proud of the remarkable commitment of the MAXONA team and look forward to initiating our Phase 2 study as soon as FDA clearance is received."
The company achieved its goal of submitting the MAX-001 IND in early Q3 2025, positioning itself to accelerate development and expand non-opioid analgesic options available to healthcare practitioners. With the submission of this IND, MAXONA is well positioned to address the pain management needs of patients through safe and effective non-opioid alternatives.
Addressing Unmet Medical Need
MAX-001 is being developed as a New Molecular Entity (NME) to provide healthcare practitioners with additional options for managing patient pain without relying on opioid or NSAID therapies. The extended-release formulation is specifically designed to provide both rapid onset and sustained duration of pain relief, potentially offering advantages over existing treatment options.
MAXONA Pharmaceuticals, headquartered in Malvern, Pennsylvania, is a privately held clinical-stage pharmaceutical company focused on developing next-generation therapies. The company's leadership team brings expertise in neuroscience, drug development, formulation and delivery technology, clinical trial design, and pharmacology to develop patient-centric therapies that are safe, efficacious, and clinically proven.
