First Exertional Heat Stroke Study of Its Kind
Conducted in Saudi Arabia during the Hajj Pilgrimage
Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) (“Eagle” or the
“Company”) today announced that the Company has successfully
completed the clinical treatment portion of its safety and efficacy
study to evaluate RYANODEX® (dantrolene sodium for injectable
suspension) for Exertional Heat Stroke (“EHS”). The first of its
kind study was conducted from September 22-27, 2015 at the Hajj
pilgrimage in Saudi Arabia. Due to the unpredictable and sudden
nature of EHS, the study was conducted in an emergency and
acute-care medical setting.
In this study, 34 EHS patients were randomized to receive
current standard of care (“SOC”) treatment or SOC plus RYANODEX.
Based on preliminary study results, participants who received
RYANODEX in combination with the SOC showed no significant
drug-related adverse events. The Company believes this patient
cohort is a sufficient number of subjects to enable assessment of a
clinically meaningful treatment effect of RYANODEX in EHS. Eagle
expects to complete the clinical data analysis during the fourth
quarter of 2015.
“The goal of this study is to collect clinically meaningful data
that will support establishing the safety and efficacy of RYANODEX
for the treatment of EHS, potentially expanding the indication of
this FDA approved product,” said Scott Tarriff, President and Chief
Executive Officer of Eagle Pharmaceuticals. “We worked closely with
the Saudi health authorities and the Saudi medical community to
implement this novel and challenging study, and are extremely
pleased with their commitment to supporting our efforts. The data
is currently under analysis, and we will be meeting with the FDA
shortly to discuss next steps and look forward to providing
additional information in due course.”
About the Study
The main protocol inclusion criteria required that eligible
study patients showed hallmark clinical features of EHS, including
the following:
- Subjects between 18-45 years of age,
and believed to have experienced exertional physical activity
within the previous 24 hours;
- Presence of neurological impairment,
which was evaluated using the Glasgow Coma Scale;
- Core body temperature of 104 degrees
Fahrenheit or greater; and
- Tachycardia (at least 100 heart beats
per minute)
A total of 34 EHS patients were randomized in a 1:1 ratio to
receive either standard of care (SOC), which consists of body
cooling by physical methods (e.g. cold water immersion, cold water
mist, ice packs application) and supportive measures, or SOC plus
RYANODEX.
Over the course of the study, patients were evaluated for
changes in core body temperature, and neurological, renal,
respiratory and cardiac functions. The Company is currently
finalizing data collection and generating the study databases.
About Ryanodex
Indication
RYANODEX (dantrolene sodium) for injectable suspension is
indicated for the treatment of malignant hyperthermia (“MH”) in
conjunction with appropriate supportive measures, and for the
prevention of malignant hyperthermia in patients at high risk.
Important Safety Information
RYANODEX is not a substitute for appropriate supportive measures
in the treatment of malignant hyperthermia, including:
- Discontinuing triggering anesthetic
agents
- Increasing oxygen
- Managing the metabolic acidosis
- Instituting cooling when necessary
- Administering diuretics to prevent late
kidney injury due to myoglobinuria (the amount of mannitol in
RYANODEX is insufficient to maintain diuresis)
Precautions should be taken when administering RYANODEX
preoperatively for the prevention of malignant hyperthermia,
including monitoring vital signs, avoiding known triggering agents,
and monitoring for early clinical and metabolic signs of malignant
hyperthermia that may indicate additional treatment is needed.
The administration of dantrolene sodium is associated with loss
of grip strength and weakness in the legs, as well as drowsiness,
dizziness, dysphagia, dyspnea, and decreased inspiratory capacity.
Patients should not be permitted to ambulate without assistance
until they have normal strength and balance. Care must be taken to
prevent extravasation of RYANODEX into the surrounding tissue due
to the high pH of the reconstituted RYANODEX suspension and
potential for tissue necrosis.
In February 2015, RYANODEX was granted seven years of U.S.
market exclusivity for the treatment of MH by the U.S. Food and
Drug Administration (“FDA”).
About Exertional Heat Stroke
Exertional Heat Stroke is a rare disorder that constitutes a
medical emergency which may result in severe multi-organ
dysfunction and death. EHS is more commonly seen in young people
undergoing exertional physical activity in a hot weather
environment, and is one of the leading causes of death in young
athletes. EHS cases are also observed in construction workers,
firefighters, military personnel, and farmers. There is no
currently approved drug product for the treatment of EHS.
About Eagle Pharmaceuticals, Inc.
Eagle is a specialty pharmaceutical company focused on
developing and commercializing injectable products that address the
shortcomings, as identified by physicians, pharmacists and other
stakeholders, of existing commercially successful injectable
products. Eagle’s strategy is to utilize the FDA's 505(b)(2)
regulatory pathway. Additional information is available on the
company’s website at www.eagleus.com.
RYANODEX® is a registered trademark of Eagle Pharmaceuticals,
Inc.
Forward-Looking Statements
This press release contains forward-looking information within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended and other securities laws. Forward-looking
statements are statements that are not historical facts. Words such
as “will,” “may,” “intends,” “anticipate(s),” “plan,” “enables,”
“potentially,” “entitles,” and similar expressions are intended to
identify forward-looking statements. These statements include, but
are not limited to, statements regarding future events including,
but not limited to: the safety and efficacy of RYANODEX for the
treatment of EHS; FDA approval of the use of RYANODEX for the
treatment of EHS; the anticipated issuance by the USPTO of
additional patents related to Eagle’s products in 2015;
difficulties or delays in manufacturing; the availability and
pricing of third party sourced products and materials; successful
compliance with FDA and other governmental regulations applicable
to manufacturing facilities, products and/or businesses; and other
factors that are discussed in Eagle’s Annual Report on Form 10-K
for the year ended September 30, 2014, and its other filings with
the U.S. Securities and Exchange Commission. All of such statements
are subject to certain risks and uncertainties, many of which are
difficult to predict and generally beyond Eagle’s control, that
could cause actual results to differ materially from those
expressed in, or implied or projected by, the forward-looking
information and statements. Such risks include, but are not limited
to: whether the FDA will ultimately approve RYANODEX for the
treatment of EHS; whether our studies will support the safety and
efficacy of RYANODEX for the treatment of EHS; the timing of
issuance by the USPTO of additional patents to Eagle related to its
products, if at all; and other risks described in Eagle’s filings
with the U.S. Securities and Exchange Commission. Readers are
cautioned not to place undue reliance on these forward-looking
statements that speak only as of the date hereof, and we do not
undertake any obligation to revise and disseminate forward-looking
statements to reflect events or circumstances after the date
hereof, or to reflect the occurrence of or non-occurrence of any
events.
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version on businesswire.com: http://www.businesswire.com/news/home/20151006005495/en/
In-Site Communications, Inc.Lisa M. Wilson,
212-452-2793President
Eagle Pharmaceuticals (NASDAQ:EGRX)
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