The Fast Track designation, established under the FDA Modernization Act of 1997, is designed to facilitate the development and expedite the review of drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
FDA may consider a "rolling review" of completed sections of the New Drug Application (NDA) before the complete application is submitted. Fast Track designation drugs ordinarily qualify for priority review, thereby expediting the FDA review process.
"We are very pleased to achieve this additional important milestone for our LHI program, following the FDA’s recent acceptance of our investigational new drug (IND) application," said Sven Jacobson, CEO of Remedy Pharmaceuticals.
"This latest development provides further momentum as we advance CIRARA, with the near-term goal to initiate our phase 3 clinical trial by the end of this year."
ABOUT THE CHARM TRIAL AND LHI
CHARM (Cirara in large Hemispheric infarction Analyzing modified Rankin & Mortality) is a phase 3 trial in patients with large hemispheric infarction (LHI). LHI is a devastating disease associated with significant disability and mortality.
Brain swelling (often termed "malignant edema") frequently occurs following LHI as a result of the opening of Sur1-Trpm4 channels in the capillary endothelium, which leads to dysfunction of the blood brain barrier. Such swelling can compromise arterial inflow to surrounding tissues, causing further ischemic damage and enlargement of the infarct, and frequently results in brain herniation and death. The risk of neurological deterioration and death is high, 40% to 80%.
ABOUT CIRARA
CIRARA is a patented, high affinity inhibitor of Sur1-Trpm4 channels, which are upregulated following ischemia and trauma. Opening of these channels can lead to edema, midline shift, increased intracranial pressure and brain herniation, culminating in permanent disability or death.
Sur1-Trpm4 channels were discovered by University of Maryland neurosurgeon Dr. J. Marc Simard, scientific founder and board member of Remedy Pharmaceuticals. CIRARA is suitable for intravenous delivery at the bedside or even in an ambulance. CIRARA uses our proprietary, patented MPD technology. CIRARA is an investigational drug and is not approved by FDA.