MAXONA Pharmaceuticals Receives FDA IND Clearance for MAX-001 Phase 2 Acute Pain Trial
核心洞察
MAXONA Pharmaceuticals (搜索) received FDA clearance of its IND application for a Phase 2 clinical trial evaluating MAX-001 for acute pain (搜索) treatment.
MAX-001 is a proprietary extended-release oral formulation of nefopam, a triple neurotransmitter re-uptake inhibitor classified as a New Molecular Entity in the U.S.
The completed Phase 1 trial demonstrated dose-proportional pharmacokinetics with no serious adverse events, premature discontinuations, or concerning clinical findings.
MAXONA Pharmaceuticals (搜索) today announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) Application for a Phase 2 clinical trial evaluating MAX-001, its lead compound, in the treatment of acute pain (搜索). The announcement, made from the company's headquarters in Malvern, Pennsylvania, marks a significant regulatory milestone for the privately held clinical-stage pharmaceutical company.
"The FDA clearance of our MAX-001 IND is an important next step towards MAXONA'S goal of providing additional safe and effective non-opioid options for patients in the U.S. who suffer from acute and chronic pain (搜索)," said Shawn Fatholahi, President & CEO of MAXONA Pharmaceuticals (搜索). "We are grateful to the FDA for their guidance and positive response to our IND submission and look forward to working with the Agency on the full development program for MAX-001."
A Novel Mechanism for Non-Opioid Analgesia
MAX-001 is a proprietary optimized extended-release (ER) solid oral formulation of nefopam, which is classified as a New Molecular Entity (NME) in the United States. Nefopam functions as a triple neurotransmitter re-uptake inhibitor, with its greatest potency on norepinephrine, followed by serotonin, and least on dopamine. When authorized for use in the U.S., MAX-001 would be the only triple monoamine re-uptake inhibitor with an indication for the treatment of acute pain (搜索).
The active ingredient has an extensive history of use outside the U.S., having been introduced for pain treatment more than 40 years ago and studied in hundreds of global clinical trials. Nefopam has been widely prescribed as an analgesic in the United Kingdom, France, and many other parts of the world in both intravenous and oral dosage forms. The MAX-001 formulation is specifically designed to deliver both a rapid onset and extended duration of analgesia.
Addressing Unmet Medical Need
"In the U.S, the non-opioid treatment of pain remains an area of substantial unmet medical need," said Roy Freeman, MD, Professor of Neurology and Director of the Center for Autonomic and Peripheral Nerve Disorders at Beth Israel Deaconess Medical Center, and Senior Medical Advisor to MAXONA Pharmaceuticals (搜索). "Nefopam was introduced outside the U.S. for the treatment of pain more than 40 years ago and has been studied in hundreds of global clinical trials which have supported the safety and efficacy of the drug."
Dr. Freeman further emphasized that the ongoing clinical development program for MAX-001 will provide new randomized, controlled, acute post-surgical pain data while evaluating the potential of MAX-001 to address the urgent need for non-opioid drugs that can provide rapid, sustained analgesia with few adverse effects.
Phase 1 Results Support Advancement
The IND clearance follows the successful completion of the MAX-001-101 Phase 1 clinical trial. Robert Rubens, MD, MBA, FAAN, Clinical Development lead for MAXONA Pharmaceuticals (搜索), reported that the Phase 1 study demonstrated dose-proportional pharmacokinetics for the proprietary optimized formulation, along with a favorable safety and tolerability profile.
"There were no reported serious adverse events, premature discontinuations due to related adverse events, or severe adverse events," said Dr. Rubens. "There were no concerning findings or abnormal trends in clinical labs, ECGs, and vital signs."
Next Steps for the Phase 2 Program
With the FDA clearance now in place, MAXONA will rapidly advance the MAX-001-201 randomized, controlled Phase 2 clinical trial, which will be conducted in the United States. The company expects to enroll the first patients within the next few months and complete the dosing phase of the study very quickly. Beyond acute pain (搜索), MAXONA is also exploring additional indications for MAX-001, including chronic pain (搜索).
MAXONA Pharmaceuticals (搜索) is distinguished by its leadership team with expertise in neuroscience, drug development, drug formulation and delivery technology, and pharmacology. The company's initial focus remains on advancing MAX-001 as a safe and highly effective non-opioid, non-NSAID treatment for acute and chronic pain (搜索).