#United States #FDA Approval #Malvern #MAX-001 #MAXONA

MAXONA Pharmaceuticals Advances Pain Management Solutions

MAXONA Pharmaceuticals has made a pivotal move in the realm of pain management by submitting an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its lead compound, MAX-001. This submission represents a significant milestone in the ongoing development of this innovative treatment designed to manage both acute and chronic pain without the reliance on opioids or non-steroidal anti-inflammatory drugs (NSAIDs).

Overview of MAX-001

MAX-001 is being developed as a proprietary extended-release formulation of nefopam. This compound has been extensively examined and is already prescribed in several countries outside the United States for its effectiveness in treating moderate to severe pain. What sets MAX-001 apart is its novel mechanism of action, functioning primarily as a triple neurotransmitter re-uptake inhibitor that targets norepinephrine, serotonin, and dopamine, making it a unique option for patients suffering from pain.

Shawn Fatholahi, the President and CEO of MAXONA Pharmaceuticals, expressed pride in the company’s accomplishments over the past six months, highlighting the team's commitment to advancing MAX-001 towards clinical trials. “With the IND submission, we are well-positioned to accelerate the development of MAX-001 and expand safe alternatives for healthcare practitioners,” he stated.

Clinical Trial Results and Safety Profile

Earlier this year, the initial results from Phase 1 clinical trials for MAX-001 demonstrated promising tolerability. No serious adverse events were reported, and participants did not discontinue the study due to related adverse effects, underscoring the safety profile of the drug. The clinical findings also showed no abnormal trends in vital signs or laboratory tests, indicating a robust safety window for this new therapy.

Robert Rubens, MD, MBA, the Clinical Development Lead at MAXONA, emphasized the importance of this IND submission, which is a culmination of extensive formulation optimization and pre-clinical studies. The results from the clinical program will be made available for publication later this year, contributing to the transparency and scientific underpinning of the drug’s development journey.

Maximizing Treatment Options for Patients

As pain management continues to be a pressing healthcare concern, the introduction of a non-opioid analgesic like MAX-001 could significantly enhance therapeutic options available to patients. Currently, the opioid crisis in the U.S. has led to a drastic need for safe and effective pain relief alternatives, and MAX-001 appears well-positioned to fill that gap upon approval.

This submission marks the fourth major development stride for MAX-001 in 2025 alone, demonstrating MAXONA’s commitment to addressing unmet medical needs through innovative approaches in pain management. With the FDA's review, stakeholders hope for a timely response that would pave the way for further clinical testing and, ultimately, commercial availability of the drug in the U.S. market.

About MAXONA Pharmaceuticals

MAXONA Pharmaceuticals is headquartered in Malvern, Pennsylvania, and is a privately held clinical-stage company focused on developing patient-centric treatments that prioritize efficacy and safety. The company boasts a diverse leadership team specializing in various fields, including neuroscience, clinical trial design, and pharmacology, all of which contribute to MAXONA’s innovative therapeutic approaches.

As the healthcare landscape evolves, the company aims to lead the charge in providing next-generation therapies that help patients lead better lives. The submission of the IND for MAX-001 is more than just a regulatory milestone; it's a testament to the dedication to bring new hope to those in need of effective pain management solutions.

For further details about MAXONA Pharmaceuticals and its innovative pipeline, please visit www.maxonapharm.com.