MALVERN, PA — MAXONA Pharmaceuticals announced the formation of its Scientific Advisory Board (SAB) and the successful completion of its inaugural meeting, marking a significant milestone in the development of MAX-001, the company’s lead non-opioid, non-NSAID pain therapy.
MAX-001 is a proprietary optimized formulation of nefopam, which has been extensively studied and widely prescribed outside the U.S. for moderate to severe acute and chronic pain. MAXONA is developing MAX-001 as a New Molecular Entity (NME) oral therapy to bring a new pain treatment option to U.S. patients.
“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 inaugural SAB 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 at Beth Israel Deaconess Medical Center in Boston.
“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.”
Preliminary Phase 1 results for MAX-001 indicated that the drug was well tolerated, with no serious adverse events or treatment-related discontinuations. MAXONA plans to submit an Investigational New Drug (IND) application and launch its 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 at CenExcel JBR and SAB participant. “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 at University Versailles Saint Quentin and Head of Center of Evaluation and Treatment of Pain, Ambroise Paré Hospital. “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 SAB participants included Dr. Praveen Anand of Imperial College London; Dr. Paul Desjardins of Rutgers and Tufts Universities; Dr. Robert Dworkin of the University of Rochester; Dr. Jessica McCoun of CenExel Atlanta; Dr. Jessica Oswald of UC San Diego Health; and Dr. Mark Wallace of UC San Diego School of Medicine.
MAX-001 is designed to deliver both rapid onset and extended duration of pain relief through a novel mechanism as a triple neurotransmitter reuptake inhibitor (N > S > D). When approved, it would be the only triple monoamine reuptake inhibitor indicated for acute pain in the U.S.
With growing demand for safer, effective pain management alternatives, MAXONA’s efforts signal a promising step toward offering new solutions for millions of patients suffering from acute and chronic pain.
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