Remedy Pharmaceuticals Receives FDA Fast Track Designation for CIRARA™

NEW YORK–(BUSINESS WIRE)–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 that the
U.S. Food and Drug Administration (FDA) has granted Fast Track
designation to its investigational drug, CIRARA, for the treatment of
Large Hemispheric Infarctions (LHI).
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%. For a White Paper on LHI, please go to: https://www.remedypharmaceuticals.com/uploads/7/1/7/3/71731607/lhi.whitepaper.3jun16.pdf
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.
ABOUT REMEDY PHARMACEUTICALS
Remedy Pharmaceuticals, Inc. is a privately-held, clinical stage
pharmaceutical company focused on developing and bringing lifesaving
treatment to people affected by acute central nervous system (CNS) edema
– including large hemispheric infarction, subarachnoid hemorrhage, and
contusional traumatic brain injury, as well as other ischemic injuries
and neurological disorders.