MALVERN, PA — MAXONA Pharmaceuticals has received U.S. Food and Drug Administration clearance to begin a Phase 2 clinical trial of its investigational non-opioid pain therapy, advancing the company’s effort to develop an alternative to opioid and nonsteroidal anti-inflammatory drugs for acute pain treatment.
The FDA cleared the company’s Investigational New Drug application for MAX-001, an extended-release oral formulation of nefopam. The randomized, controlled Phase 2 study will be conducted in the United States, with patient enrollment expected to begin within the next few months, the company said.
MAX-001 is being developed for the treatment of acute and chronic pain. Its active ingredient, nefopam, has been prescribed for decades in countries including the United Kingdom and France but has not been approved for use in the United States, making it a new molecular entity under the FDA’s regulatory framework.
If ultimately approved, MAXONA said MAX-001 would become the first triple monoamine reuptake inhibitor authorized in the United States for treating acute pain.
The Phase 2 trial will evaluate the drug in patients with acute post-surgical pain as the company seeks to generate randomized, controlled clinical data to support future regulatory submissions.
“In the U.S., the non-opioid treatment of pain remains an area of substantial unmet medical need,” said Dr. Roy Freeman, senior medical advisor to MAXONA Pharmaceuticals. He added that decades of international experience with nefopam, combined with the U.S. clinical program, are intended to evaluate whether the therapy can provide rapid, sustained pain relief with limited adverse effects.
The Phase 2 study follows completion of the company’s Phase 1 trial, which MAXONA reported found the investigational therapy to be safe and well tolerated. According to the company, the study reported no serious adverse events, no treatment-related discontinuations and no significant safety concerns in laboratory testing, electrocardiograms or vital signs.
MAXONA said it expects to complete dosing for the Phase 2 study shortly after enrollment begins.
Support the local news that supports Chester County. MyChesCo delivers reliable, fact-based reporting and essential community resources—free for everyone. If you value that, click here to become a patron today.