MAXONA PHARMACEUTICALS RECEIVES FDA IND CLEARANCE FOR MAX-001 PHASE 2 ACUTE PAIN CLINICAL TRIAL

MAXONA Pharmaceuticals is developing MAX-001, a non-opioid, non-NSAID solid oral prescription therapy aimed at treating acute and chronic pain, along with potential additional indications. The drug features a proprietary optimized extended release formulation of nefopam.

Nefopam is a new molecular entity in the U.S. with a well-documented safety and efficacy profile, supported by extensive use in countries such as the U.K. and France. The company recently announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a Phase 2 clinical trial to assess MAX-001 in the treatment of acute pain.

Shawn Fatholahi, President and CEO of MAXONA Pharmaceuticals, emphasized the significance of the FDA clearance, noting it as a crucial step toward providing safe and effective non-opioid options for patients dealing with acute and chronic pain. He expressed gratitude to the FDA for their guidance and support during the IND submission process.

MAX-001 is designed as a triple neurotransmitter re-uptake inhibitor, with the most significant effect on norepinephrine, followed by serotonin, and the least on dopamine. It aims to offer both rapid onset and prolonged analgesia. Once authorized for use in the U.S., MAX-001 will be the only triple monoamine re-uptake inhibitor indicated for acute pain treatment.

Dr. Roy Freeman, a Senior Medical Advisor for MAXONA, highlighted the ongoing need for non-opioid treatment options in the U.S., noting that nefopam has been used successfully for over 40 years in other countries. The clinical development program for MAX-001 seeks to gather new data on controlled, acute post-surgical pain.

Following the FDA clearance, MAXONA plans to advance the MAX-001-201 Phase 2 clinical trial in the U.S., with expectations to enroll the first patients shortly and complete the dosing phase quickly. The company previously completed the MAX-001-101 Phase 1 clinical trial, which reported favorable safety and pharmacokinetic results without any serious adverse events.