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
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.
"In the U.S, the non-opioid treatment of pain remains an area of substantial unmet medical need," said Roy Freeman, MD, Professor of Neurology and Director, Center for Autonomic and Peripheral Nerve Disorders, Beth Israel Deaconess Medical Center, and Senior Medical Advisor, MAXONA Pharmaceuticals. "Nefopam was introduced outside the U.S. for the treatment of pain more than 40 years ago and has been studied in hundreds of global clinical trials which have supported the safety and efficacy of the drug. The ongoing clinical development program for MAX-001 will provide new randomized, controlled, acute post-surgical pain data while fully evaluating the potential of MAX-001 to address the urgent need for non-opioid drugs that can provide rapid, sustained analgesia with few adverse effects."
"MAXONA has already completed the MAX-001-101 Phase 1 clinical trial which demonstrated that the MAX-001 proprietary optimized formulation had dose-proportional pharmacokinetics and was safe and well tolerated, "said Robert Rubens, MD, MBA, FAAN, and Clinical Development lead for MAXONA Pharmaceuticals. "There were no reported serious adverse events, premature discontinuations due to related adverse events, or severe adverse events. There were no concerning findings or abnormal trends in clinical labs, ECGs, and vital signs."
With the FDA clearance in place, MAXONA will now rapidly advance the MAX-001-201 randomized, controlled Phase 2 clinical trial which will be conducted in the U.S. MAXONA expects to enroll the first patients within the next few months and complete the dosing phase of this study very quickly.
About MAXONA Pharmaceuticals
MAXONA Pharmaceuticals, headquartered in Malvern, PA, is a privately held clinical-stage pharmaceutical company committed to developing the next generation of therapies to help patients maximize life. The Company is distinguished by its strong leadership team with expertise in neuroscience, drug development, drug formulation and delivery technology, and pharmacology to develop patient-centric therapies that are safe, efficacious, clinically proven and trusted by physicians and their patients. The Company's initial focus is on advancing MAX-001 as a safe and highly effective non-opioid treatment of acute and chronic pain.
For more information, please visit www.maxonapharm.com.
Cautionary Statement Regarding Forward Looking Statements
This release includes forward looking statements. All statements contained herein other than statements of historical facts are forward-looking statements. The words "anticipate," "believe," "continue," "estimate," "expect," "intend," "may," "will," "completes" and similar expressions are intended to identify forward-looking statements. These forward-looking statements, including regulatory timelines, are subject to a number of risks, uncertainties, and assumptions. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the future events discussed herein may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. We cannot guarantee future results, levels of activity, performance, achievements or events and circumstances reflected in the forward-looking statements will occur. We are under no duty to update any of these forward-looking statements after the date of this release to conform these statements to actual results or revised expectations, except as required by law. Nothing in this release should be regarded as a representation by any person that these goals will be achieved.
Dr. Roy Freeman is a paid consultant for MAXONA Pharmaceuticals.
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