Ghent, Belgium, 21st August 2025
Ardena, a specialist pharmaceutical CDMO and bioanalytical CRO enabling precision medicines and other complex therapies, today announced a strategic partnership with MAXONA Pharmaceuticals, a clinical-stage pharmaceutical company committed to developing the next generation of therapies to help patients maximize life. The collaboration will support the development and manufacturing of MAX-001, which is being developed by MAXONA as a New Molecular Entity (NME), non-opioid, non-NSAID oral therapy for the treatment of acute and chronic pain.
MAX-001 is a proprietary optimized formulation of nefopam, which has been studied extensively and widely prescribed outside the United States as a 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 exerting its effect primarily through a novel mechanism of action as a triple neurotransmitter re-uptake inhibitor with a potency profile 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.
Ardena’s Somerset facility, a Center of Excellence for advanced oral dosage forms, will leverage its expertise in complex formulations to enhance MAX-001’s bioavailability and expedite progression from development through clinical and commercial supply.
“Our collaboration with MAXONA reflects Ardena’s strength in developing advanced oral drug products and our ability to apply unique formulation strategies that improve therapeutic performance,” said Ian Bilodeau, General Manager of Ardena’s Somerset site. “By combining our technical expertise with MAXONA’s innovative approach to pain management, we aim to accelerate the delivery of a much-needed non-opioid treatment option.”
About Ardena
Ardena is a specialist pharmaceutical Contract Development and Manufacturing Organization (CDMO) and bioanalytical Contract Research Organization (CRO) dedicated to advancing precision medicines. Its integrated solutions enable innovative and complex molecules through services in nanomedicine, drug product and substance manufacturing, solid-state chemistry, bioanalytical services, and CMC regulatory support.
About MAXONA Pharmaceuticals
MAXONA 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.
