MAXONA PHARMACEUTICALS HOLDS INAUGURAL SCIENTIFIC ADVISORY BOARD MEETING

Scientific Advisory Board Meeting Marks Important Milestone in Clinical Development Plan for MAX-001

MAX-001 is a Non-Opioid, Non-NSAID Oral Therapy in Development for Treatment of Acute and Chronic Pain

MALVERN, Pa., July 9, 2025 /PRNewswire/ -- MAXONA Pharmaceuticals today announced the formation of its Scientific Advisory Board (SAB) and completion of the inaugural SAB meeting for MAX-001, the company's lead compound being developed in the United States as a New Molecular Entity (NME), non-opioid, non-NSAID oral therapy for the treatment of acute and chronic pain. MAXONA Pharmaceuticals is developing MAX-001 as a proprietary optimized formulation of nefopam, which has been studied extensively and widely prescribed outside the United States as a treatment for moderate to severe acute and chronic pain.

"We are extremely pleased with the progress to date in bringing MAX-001 to the U.S. market and the launch of this Scientific Advisory Board marks another key milestone in our development program," said Shawn Fatholahi, President & CEO of MAXONA Pharmaceuticals.

The MAX-001 Scientific Advisory Board meeting was chaired by Roy Freeman, MD, Professor of Neurology at Harvard Medical School and Director of the Center for Autonomic and Peripheral Nerve Disorders in the Department of Neurology at Beth Israel Deaconess Medical Center in Boston, Massachusetts.

"The field of pain management continues to evolve at a rapid pace," said Dr. Freeman. "During such a dynamic and demanding period, I am grateful to my fellow SAB participants for their support of this important initiative. The Board participants represent a broad base of distinguished healthcare professionals with expertise in key aspects of pain management including clinical research and drug development as well as notable international experts who are familiar with nefopam, both in terms of the extensive body of clinical research and direct patient experience."

Earlier this year, MAXONA released preliminary Phase 1 clinical trial results which show that MAX-001 was well tolerated with no serious adverse events or treatment related discontinuations. The company plans to submit the MAX-001 Investigational New Drug application (IND) and launch the Phase 2 clinical program later this year.

"It is an exciting time in the field of pain management with innovative efforts underway to bring new non-opioid, non-NSAID oral therapy options to market for patients in the U.S. who suffer from acute and chronic pain," said Todd Bertoch, MD, Principal Investigator, CenExcel JBR, and a participant in the MAX-001 Scientific Advisory Board. "In addition to innovation in drug development, we are also expanding our perspective in treating acute and chronic pain and taking a more multi-modal approach to how these treatment options can work together. Given the proprietary formulation and unique mechanism of action, MAX-001 has the potential to be used as an important new single therapy, as well as in combination with other pain treatment options to deliver the best outcome for patients."

"Nefopam has been available in France for years and it continues to be extensively used for the treatment of acute and chronic pain because it offers a quick onset of action and good potency," said Nadine Attal, Professor of Therapeutics and Pain Medicine, University Versailles Saint Quentin, Head of Center of Evaluation and Treatment of Pain, Ambroise Paré Hospital and Mavern C branch for Rare Disease, and participant in the MAXONA Scientific Advisory Board meeting. "I was pleased to share my own experience in prescribing nefopam with the other meeting participants and learn more about the MAX-001 development program, which provided further evidence of the safety, tolerability and pharmacokinetics of nefopam."

Other participants in the MAXONA Scientific Advisory meeting included:

Praveen Anand, MD, MCRP, FRCP
Professor of Clinical Neurology and Head, Centre for Clinical Translation
Imperial College
London, United Kingdom

Paul Desjardins, D.M.D., PhD
Adjunct Professor
Rutgers School of Dental Medicine
Tufts University School of Dental Medicine
Newark, New Jersey 

Robert Dworkin, PhD
Professor of Anesthesiology and Perioperative Medicine, and Neurology
Professor, Center for Health + Technology
University of Rochester School of Medicine and Dentistry
Rochester, New York

Jessica McCoun, MD
Principal Investigator
CenExel
Atlanta Center for Medical Research
Atlanta, Georgia

Jessica Oswald, MD, MPH
Associate Professor in Emergency Medicine and Pain Management
Division of Pain Management,
Department of Anesthesiology
UC San Diego Health
San Diego, California

Mark Wallace, MD
Member and former director, UC San Diego Health Center for Pain Management
Professor, Division of Pain Management, Department of Anesthesiology, UC San Diego School of Medicine
San Diego, California

About MAX-001

MAX-001 is a proprietary optimized formulation of nefopam, a non-opioid, non-NSAID analgesic which has been studied extensively and widely prescribed for acute and chronic pain outside the United States. MAX-001 is designed specifically to deliver both a rapid onset and extended duration of analgesia exerting its effect primarily through a novel mechanism of action as a triple neurotransmitter re-uptake inhibitor with a potency profile being significantly greater for norepinephrine than serotonin, and dopamine respectively (N > S > D). 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.

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 and diversified leadership team with expertise in neuroscience, drug development, drug formulation and delivery technology, clinical trial design 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 option for the treatment of acute and chronic pain.

For more information, please visit www.maxonapharm.com.

Cautionary Statement Regarding Forward Looking Statements

This release may contain "forward-looking statements". Forward-looking statements are identified by certain words or phrases such as "may", "will", "aim", "will likely result", "believe", "expect", "will continue", "anticipate", "estimate", "intend", "plan", "contemplate", "seek to", "future", "objective", "goal", "project", "should", "will pursue" and similar expressions or variations of such expressions. These forward-looking statements reflect the company's current expectations about its future plans and performance. These forward-looking statements rely on a number of assumptions and estimates which could be inaccurate and which are subject to risks and uncertainties. Actual results could vary materially from those anticipated or expressed in any forward-looking statement made by the company. The company disclaims any obligation or intent to update the forward-looking statements in order to reflect events or circumstances after the date of this release.

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SOURCE Maxona Pharmaceuticals