MAX-001 is a Non-Opioid, Non-NSAID Oral Therapy in Development for Treatment of Acute and Chronic Pain Preliminary Results of Phase 1 Clinical Trial Demonstrate MAX-001 is Well Tolerated with no Serious Adverse Events or Treatment Related Discontinuations MALVERN, Pa. , March 18, 2025 /PRNewswire/ -- MAXONA Pharmaceuticals today announced the preliminary results of the Phase 1 clinical program for MAX-001, which is in development as a New Molecular Entity (NME), non-opioid, non-NSAID oral therapy for the treatment of acute and chronic pain. The results show that MAX-001 was well tolerated with no serious adverse events or treatment related discontinuations.
MAXONA Pharmaceuticals is developing MAX-001 as 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 .
"From an overall perspective, our goal in developing MAX-001 is to provide a significant new non.