NEW YORK, March 04, 2016 (GLOBE NEWSWIRE) -- Remedy Pharmaceuticals, a privately-held, pharmaceutical company focused on bringing life saving hospital-based treatment to people affected by central nervous system (CNS) related edema, today announced the successful completion of an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), which took place on March 2, 2016.
“Our End-of-Phase 2 meeting was a decisive milestone for the Company as we advance the clinical development of CIRARA™,” states Sven Jacobson, Chief Executive Officer of Remedy Pharmaceuticals. “We are pleased with the FDA’s guidance on our Phase 3 trial design in patients with large hemispheric stroke and we look forward to initiating the study as quickly as possible.”
“There is a major unmet medical need to treat CNS-related edema,” said David Geliebter, Executive Chairman of Remedy Pharmaceuticals. “The encouraging data from our Phase 2 studies suggest CIRARA has the potential to reduce mortality and improve functional outcomes for patients with large hemispheric strokes. We’re now one step closer to achieving that goal.”
ABOUT CIRARA
CIRARA is a patented, high affinity inhibitor of Sur1-Trpm4 channels, discovered by University of Maryland neurosurgeon Dr. J. Marc Simard. CIRARA is suitable for intravenous delivery at the bedside or even in an ambulance. CIRARA uses our proprietary, patented MPD™ measured phase dosing technology. CIRARA is an investigational drug and is not approved by FDA.
ABOUT REMEDY PHARMACEUTICALS
Remedy Pharmaceuticals, Inc. is a privately-held, clinical stage pharmaceutical company focused on developing and bringing lifesaving treatment to millions of people affected by acute central nervous system (CNS) edema – including stroke, traumatic brain injury, spinal cord injury, as well as other ischemic injuries and neurological disorders.