MAX-001 is a Non-Opioid, Non-NSAID Oral Therapy in Development for Acute and Chronic Pain
MALVERN, Pa., Feb. 11, 2025 /PRNewswire/ -- MAXONA Pharmaceuticals today announced that it has emerged from stealth with the completion of the U.S. Phase 1 clinical development program for the company’s first to market product, MAX-001, as a New Molecular Entity (NME), non-opioid, non-NSAID oral therapy for the treatment of acute and chronic pain.
MAXONA Pharmaceuticals was founded by President & CEO Shawn Fatholahi as a clinical stage pharmaceutical company committed to developing the next generation of therapies that help patients with pain to maximize life. Mr. Fatholahi had witnessed the devastating impact of the U.S. opioid abuse epidemic in his own community. As a result, he focused MAXONA’s initial efforts on finding alternative options to address the need in the U.S. market for effective pain therapies that are not burdened with the side-effects of NSAIDs and the addiction risk of opioids. The MAXONA team identified nefopam, the active ingredient in MAX-001, which has been proven as a safe and effective non-opioid painkiller in hundreds of global clinical studies and currently used as a prescription-only medicine to treat acute and chronic pain in twenty-three countries around the world including the United Kingdom, France, and several other parts of Europe and east Asia.
“We are very pleased to reach this important milestone in the history of MAXONA Pharmaceuticals,” said Mr. Fatholahi. “Over the past few years, we have worked diligently to build a world-class management team that has a unique combination of experience in all aspects of drug development and commercialization to capitalize on opportunities to bring new therapies such as MAX-001 to the U.S. market. After completion of an extensive formulation optimization process and comprehensive IND-enabling pre-clinical studies, we are excited to have now completed our Phase 1 clinical program as we work to bring our lead asset, MAX-001 to the U.S. market, as a safe and highly effective non-opioid, non-NSAID oral therapy initially for the treatment of acute pain and, subsequently, chronic pain.”
Beyond the MAX-001 platform, the company is committed to applying its intellectual property and unique expertise in neuroscience, drug development, drug formulation and delivery technology, and clinical trial design and pharmacology to develop additional patient-centric therapies that are safe and effective options to advance care and address unmet medical needs. The company raised an eight figure Series A round of funding in 2021 and recently closed a Series B offering which included participation from new and existing Institutional, High Net Worth and Family Office investors.
Mr. Fatholahi brings more than 20 years of pharmaceutical senior leadership experience to his current role as President & CEO, MAXONA Pharmaceuticals. Prior to founding MAXONA, Mr. Fatholahi was Vice President of Sales and Marketing for Impax Laboratories, where he built the Impax commercial brand business from the ground up and grew it to more than $245 million in profitable revenues through a combination of organic growth and business development. Mr. Fatholahi has a record of success across a range of therapeutic areas including Central Nervous System (CNS) disorders and has extensive experience in the launch of blockbuster, specialty, orphan-designated, oral and injectable products.
In addition to Mr. Fatholahi, other members of the MAXONA Pharmaceuticals’ leadership team include:
- Richard Brand, Chief Financial Officer – Mr. Brand has more than 30 years of experience in senior financial roles across all aspects of the financial sector. Notably, as chief financial officer of Beyond Spring, a global biopharmaceutical company focused on developing innovative immuno-oncology therapies, Mr. Brand generated a nine times return in two years for investors. Under Mr. Brand’s financial leadership, the company was recognized as the best performing biotech for much of its vintage year.
- Roy Freeman, MD, Senior Medical Advisor – Dr. Freeman is Professor of Neurology at Harvard Medical School and a world-renowned authority on neuropathic pain, neuropathic pain clinical trial design, and peripheral nervous system disorders. Dr. Freeman has been providing MAXONA with key scientific, medical, and clinical development guidance since the company’s inception and is the founder and current Chairman of its Scientific Advisory Board (SAB). Dr. Freeman formerly served on the Executive Committee and the Steering Committee of the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION), a public-private partnership with the U.S Food and Drug Administration.
- Robert Rubens, MD, MBA, FAAN, Clinical Development – Dr. Rubens is a board-certified neurologist and recognized as an expert in all facets of neuroscience clinical development, clinical trial design and execution. Dr. Rubens has directly overseen multiple development programs leading to several regulatory filings (INDs, NDAs) and successful product approvals.
- Gary Maier, Ph.D. Pharmacokinetics – Dr. Maier is an accomplished executive and key opinion leader in clinical pharmacology. In Dr. Maier’s former roles in clinical pharmacology and clinical bioanalytical/ADME, he was a key developer of novel methods and responsible for ground-up development of model-based pharmacokinetic responses.
- Bruce Rehlaender, Ph.D. Formulation Development/CMC – Dr. Rehlaender has more than 30 years of experience in formulation, drug delivery technologies, and drug product manufacturing and is considered an expert in deploying computer models to analyse PK data and predict ideal drug characteristics as well as managing manufacture of clinical trial materials and regulatory submissions.
- Paul Tarantino, Ph.D. Preclinical Development (consulting) – Dr. Tarantino is a highly recognized pharmaceutical development consultant with over 25 years of experience in nonclinical support of drug discovery and development organizations. Dr. Tarantino is a specialist in therapeutic development for CNS, oncology, and rare diseases with extensive experience in interfacing with US FDA and international regulatory authorities.
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
