MAXONA PHARMACEUTICALS RECEIVES NOTICE OF ALLOWANCE FOR ITS PATENT APPLICATION RELATING TO THE USE OF NEFOPAM IN THE TREATMENT OF PRURITUS

MAXONA Also Announces Expansion of Its Pipeline with Development of MAX-425 for the Treatment of Chronic Pruritus of Unknown Origin

Nefopam is the Active Ingredient in MAX-425 and MAX-001, Which Is in Development for the Treatment of Acute and Chronic Pain

Latest Developments Reflect MAXONA's Commitment to Exploring the Full Potential of Nefopam as a Pipeline in a Molecule

MALVERN, Pa., Oct. 27, 2026 /PRNewswire/ -- MAXONA Pharmaceuticals today announced the United States Patents and Trademarks Office (USPTO) has issued a notice of allowance for the company's method of treatment patent application (19/718,131) for the use of nefopam in the treatment of pruritus. The company expects the USPTO to issue the final patent by year-end. MAXONA also plans to file a continuation patent application seeking additional protection for the use of nefopam in the treatment of pruritus. With this latest patent, MAXONA will hold a total of six U.S. Patents that cover compositions comprising nefopam and uses of nefopam. 

The company also announced that it has begun pre-clinical work on MAX-425 for the treatment of Chronic Pruritus of Unknown Origin (CPUO). Nefopam is the active ingredient in MAX-425 as well as in MAX-001, which is in development for the treatment of acute and chronic pain.

"Today's developments reflect MAXONA'S commitment to fully exploring the potential of nefopam as a therapeutic agent and further strengthening the Company's intellectual property position," said Shawn Fatholahi, president and CEO of MAXONA Pharmaceuticals. "These milestones, along with the continued progress of our MAX-001 clinical program, enhance our ability to achieve our ultimate goal of bringing new therapeutic options to market to address the unmet needs of patients who suffer from acute and chronic conditions."

The estimates for the prevalence of chronic pruritus run in the tens of millions of patients worldwide with 9 million in the United States alone¹. While there are immunological, neurological, psychiatric, and environmental causes, approximately 2 million patients² in the U.S. suffer from CPUO, which is defined as persistent itching with no identifiable cause that lasts six weeks or longer. Currently, there are no FDA approved treatments and therapy involves using off-label products with trial and error to identify the most effective option.

"CPUO is a serious and debilitating condition that significantly impacts quality of life so there is a compelling need to identify new and better treatment options," said Fatholahi. "We are excited by the results of our research to date which suggests that MAX-425 may represent a first-in-class therapeutic option that is uniquely positioned to treat CPUO via its multiple central and peripheral mechanisms of action."

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.

References:

1) DelveInsight 2015
2) Stander 2015

SOURCE Maxona Pharmaceuticals