MAXONA Pharmaceuticals is Developing MAX-001 as a Non-Opioid, Non-NSAID Oral Therapy for the Treatment of Acute and Chronic Pain
IND Submission Marks Fourth Significant Development Milestone for MAX-001 in 2025
MALVERN, Pa., Aug. 7, 2025 /PRNewswire/ -- MAXONA Pharmaceuticals today announced that the company has submitted an Investigational New Drug (IND) Application to the U.S. Food and Drug Administration (FDA) for the company's lead compound, MAX-001, for the treatment of acute pain. MAX-001 is being developed as a New Molecular Entity (NME), non-opioid, non-NSAID oral therapy for the treatment of acute and chronic pain.
"During the past six months, MAXONA has achieved a number of important MAX-001 development milestones," said Shawn Fatholahi, President & CEO of MAXONA Pharmaceuticals. "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. With the submission of this IND, we are well positioned to accelerate development of MAX-001 and expand the options for safe and effective non-opioid analgesics available to healthcare practitioners to address the pain management needs of their patients."
MAXONA Pharmaceuticals is developing MAX-001 as a proprietary optimized extended-release (ER) formulation of nefopam, which has been studied extensively and widely prescribed outside the United States as a non-scheduled treatment for moderate to severe acute and chronic pain. MAX-001 is designed specifically to deliver both a rapid onset and extended duration of analgesia.
Earlier this year, MAXONA released Phase 1 clinical trial results that showed MAX-001 was well tolerated. There were no reported serious adverse events, early 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.
"We are pleased to achieve our goal of submitting the MAX-001 IND in early Q3 2025," said Robert Rubens, MD, MBA, FAAN, and Clinical Development lead for MAXONA Pharmaceuticals. "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."
About MAX-001
MAX-001 is a proprietary optimized extended-release (ER) formulation of nefopam, a non-opioid, non-NSAID analgesic that 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 relative potency greatest for norepinephrine reuptake inhibition, and reuptake inhibition of serotonin greater than dopamine. 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
