MAXONA PHARMACEUTICALS GRANTED FIFTH PATENT FOR FIRST TO MARKET PRODUCT MAX-001

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

MALVERN, Pa., Feb. 25, 2025 /PRNewswire/ -- MAXONA Pharmaceuticals today announced the United States Patents and Trademark Office (USPTO) has issued Patent No. 12,226,421 for MAX-001, the company’s first to market product which is a non-opioid, non-NSAID oral therapy for the treatment of acute and chronic pain. With the issuance of this patent, Maxona Pharmaceuticals now holds a total of five Method of Use and Composition of Matter patents that cover research and uses of nefopam, the active ingredient in MAX-001.

“As a company, one of our priorities has been to develop a strong intellectual property position for MAX-001,” said Shawn Fatholahi, president and CEO of Maxona Pharmaceuticals, and the named inventor on the patents. “The addition of this new patent further strengthens our intellectual property portfolio. It also underscores our commitment to fully exploring and leveraging the potential of MAX-001 for its initial indications to treat acute and chronic pain as well as other indications in the future. As we continue to advance our development program for MAX-001, we will seek additional patents related to specific areas of use and optimal formulation of the product by leveraging the company’s formulation technology and expertise.”

Over the past few years, Maxona Pharmaceuticals has built a world-class management team that has unique 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, Maxona Pharmaceuticals completed the MAX-001 Phase 1 clinical program earlier this year. The compound will enter Phase 2 clinical trials later this year.

About MAX-001

MAX-001 is an optimized formulation of nefopam hydrochloride which is a non-opioid, non-NSAID solid oral therapy being developed as a New Molecular Entity (NME) intended for the treatment of acute and chronic pain in 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 the order of strength being significantly greater for norepinephrine than serotonin, and dopamine respectively (N > S > D). When approved for use, MAX-001 will be the only triple monoamine re-uptake inhibitor with an indication for the treatment of acute pain in the United States.

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