Clinical-stage pharmaceutical company MAXONA Pharmaceuticals announced on Wednesday that the US Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) Application for a Phase 2 clinical trial to evaluate its lead compound, MAX-001, in the treatment of acute pain.

MAXONA is developing MAX-001 as a New Molecular Entity (NME), non-opioid, oral therapy for the treatment of acute and chronic pain, while also exploring additional indications. The active ingredient in MAX-001 is nefopam, which has been studied extensively and widely prescribed as an analgesic outside the US in intravenous and oral dosage forms. Nefopam is a triple neurotransmitter re-uptake inhibitor delivering a potency of effect greatest on norepinephrine, then serotonin, and least on dopamine.

According to MAXONA, MAX-001 is a proprietary optimised extended release (ER) solid oral formulation of nefopam, and is designed specifically to deliver both a rapid onset and extended duration of analgesia. When authorised for use in the US, MAX-001 would be the only triple monoamine re-uptake inhibitor with an indication for the treatment of acute pain.

With the FDA clearance in place, MAXONA intends to advance the MAX-001-201 randomised, controlled Phase 2 clinical trial, which will be conducted in the US.