MAXONA PHARMACEUTICALS RECEIVES FDA IND CLEARANCE FOR MAX-001 PHASE 2 ACUTE PAIN CLINICAL TRIAL
MAXONA is Developing MAX-001 as a Non-Opioid, Non-NSAID Solid Oral Prescription Therapy for the Treatment of Acute and Chronic Pain and Potential Additional Indications
MAX-001 is a Proprietary Optimized Extended Release Form of Nefopam
Nefopam is a New Molecular Entity (NME) in the U.S. with a Well Documented Safety and Efficacy Profile in Treating Acute and Chronic Pain based on Extensive History of Use in the U.K., France, and Many other Parts of the World
Excerpt from the Press Release:
MALVERN, Pa., July 15, 2026 /PRNewswire/ — MAXONA Pharmaceuticals today announced the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) Application for a Phase 2 clinical trial to evaluate MAX-001, the Company’s lead compound, in the treatment of acute pain.
“The FDA clearance of our MAX-001 IND is an important next step towards MAXONA’S goal of providing additional safe and effective non-opioid options for patients in the U.S. who suffer from acute and chronic pain,” said Shawn Fatholahi, President & CEO of MAXONA Pharmaceuticals. “We are grateful to the FDA for their guidance and positive response to our IND submission and look forward to working with the Agency on the full development program for MAX-001.”
MAXONA Pharmaceuticals is developing MAX-001 as a New Molecular Entity (NME), non-opioid, oral therapy for the treatment of acute and chronic pain while also exploring additional indications. The active ingredient in MAX-001 is nefopam, which has been studied extensively and widely prescribed as an analgesic outside the U.S. in intravenous and oral dosage forms. Nefopam is a triple neurotransmitter re-uptake inhibitor delivering a potency of effect greatest on norepinephrine, then serotonin, and least on dopamine. MAX-001 is a proprietary optimized extended release (ER) solid oral formulation of nefopam and is designed specifically to deliver both a rapid onset and extended duration of analgesia. When authorized 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.
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