MAXONA Pharmaceuticals has submitted an investigational new drug (IND) application seeking approval from the US Food and Drug Administration (FDA) for its lead compound, MAX-001, to treat acute pain.

The compound is being developed as a non-opioid, new molecular entity, non-steroidal anti-inflammatory drugs oral therapy for acute and chronic pain management.

The company is developing MAX-001 as an optimised extended-release formulation of nefopam, which has been studied and prescribed outside the US as a non-scheduled moderate to severe acute and chronic pain treatment.

MAXONA Pharmaceuticals president and CEO Shawn Fatholahi stated: "During the past six months, MAXONA has achieved a number of important MAX-001 development milestones. I am extremely proud of the remarkable commitment of the MAXONA team and look forward to initiating our Phase 2 study as soon as FDA clearance is received.

“With the submission of this IND, we are well-positioned to accelerate the development of MAX-001 and expand the options for safe and effective non-opioid analgesics available to healthcare practitioners to address the pain management needs of their patients."

The therapy is specifically designed to provide rapid onset of pain relief as well as extended duration of analgesia.

Its mechanism of action functions as a triple neurotransmitter reuptake inhibitor, exhibiting the highest potency for norepinephrine reuptake inhibition, followed by serotonin, and then dopamine.

When approved for use in the US, MAX-001 will be the only triple monoamine reuptake inhibitor indicated for acute pain.

In early 2025, Phase I clinical trial data of the therapy showed it to be well-tolerated among participants.

There were no reported serious adverse events or early discontinuations due to related adverse events, and no concerning findings or abnormal trends were observed in ECGs, clinical labs and vital signs.