Schering-Plough
Corporation (NYSE: SGP) announced that the European Commission (EC)
has approved BRIDION(R) (sugammadex) injection, the first and only
selective relaxant binding agent (SRBA) and the first major pharmaceutical
advance in the field of anesthesia in two decades. BRIDION is indicated for
routine reversal of the commonly used muscle relaxants rocuronium or
vecuronium and for immediate reversal of rocuronium in adults, and for
routine reversal following rocuronium in children and adolescents (2-17
years of age). Rocuronium and vecuronium are given as part of general
anesthesia to relax a patient's muscles during surgery, and are marketed in
Europe under the trade names ESMERON(R) and NORCURON(R), respectively.
BRIDION works in an entirely novel way by encapsulating the muscle
relaxant molecule and rendering it inactive. It was specifically designed
to reverse within minutes both moderate and deep muscle relaxation induced
by rocuronium or vecuronium during general anesthesia. As a result, BRIDION
can give anesthesiologists greater control in managing the depth of muscle
relaxation through to the end of a surgical procedure. This may help
improve surgical conditions in the millions of procedures where these
agents are used.
"This approval of BRIDION represents the first advance in two decades
for anesthesiologists and their patients, and has the potential to
transform the practice of anesthesia," said Thomas P. Koestler, Ph.D.,
executive vice president and president of Schering-Plough Research
Institute. "This is the first major approval of a product from our
combination with Organon BioSciences and is a significant achievement for
Schering-Plough. This further validates the value of our combination, which
closed in November 2007, and is already making a positive contribution to
our business."
BRIDION has a rapid onset and, in addition to routine reversal, can be
used in critical situations when immediate reversal of rocuronium is
needed. In BRIDION clinical studies, the median time to reversal of
rocuronium was about three minutes.
A muscle relaxant plays several critical roles in general anesthesia.
Anesthesiologists use muscle relaxation to improve surgical conditions and
to facilitate intubation and mechanical ventilation. Reversal agents
reverse the effects of muscle relaxants, enabling patients to regain normal
muscle function sooner and breathe on their own. Current reversal agents
are slow and are associated with certain undesirable side effects,
including cardiac rhythm disturbances and gastrointestinal and pulmonary
side effects.
"The ability to rapidly reverse both moderate and deep levels of muscle
relaxation during general anesthesia was not possible before BRIDION," said
Rajinder Mirakhur, M.D., professor of anesthetics at The Queen's University
of Belfast, Northern Ireland, and a principal investigator in the BRIDION
clinical trials program. "BRIDION can provide us with greater flexibility
to induce and maintain the level of muscle relaxation with rocuronium or
vecuronium necessary throughout surgery and reverse that relaxation quickly
when needed."
BRIDION (sugammadex) Clinical Trials
The EC approval of BRIDION is based on an extensive clinical trial
database of approximately 1,800 patients and volunteers, including data
from the SIGNAL, AURORA and SPECTRUM clinical trials. The SIGNAL trial
involved adult patients undergoing surgery. Rocuronium was administered at
a standard dose to allow intubation, followed by maintenance doses as
required. When 1-2 post-tetanic counts (PTC) were observed following
neuromuscular stimulation (deep block), patients were administered either
sugammadex or neostigmine plus glycopyrrolate, a current reversal regimen.
In the SIGNAL trial, the median time to reversal of muscle relaxation to a
train-of-four (TOF) ratio of 0.9 occurred in 2.7 minutes in the sugammadex
group compared to 49.0 minutes in the neostigmine/glycopyrrolate group.
The AURORA trial involved adult patients undergoing surgery. Rocuronium
was administered at a standard dose to allow intubation, followed by
maintenance doses as required. At the reappearance of the second twitch
(T2) in a TOF stimulation (moderate block) patients were administered
either sugammadex or neostigmine plus glycopyrrolate. In the AURORA trial,
the median time to reversal of muscle relaxation to a TOF ratio of 0.9
occurred in 1.4 minutes in the sugammadex group compared to 17.6 minutes in
the neostigmine/glycopyrrolate group.
The SPECTRUM trial was conducted in adult patients undergoing surgery
to study the immediate reversal of muscle relaxation. Patients were
randomized to receive either rocuronium plus sugammadex or the rapid-onset,
short- duration muscle relaxant succinylcholine. The trial demonstrated
that rocuronium followed by sugammadex is an effective alternative to
succinylcholine.
The EC approval of BRIDION follows a positive opinion by the Committee
for Medicinal Products for Human Use (CHMP) of the European Medicines
Agency (EMEA) that was received in May of this year.
About BRIDION (sugammadex)
BRIDION, the first and only selective relaxant binding agent (SRBA), is
the first major pharmaceutical advance in the field of anesthesia in two
decades. It was specifically designed to rapidly reverse both moderate and
deep muscle relaxation induced by the commonly used muscle relaxants
rocuronium bromide (ZEMURON(R)/ESMERON/ESLAX(R)) or vecuronium bromide
(NORCURON/MUSCULAX(R)), which can give anesthesiologists greater control
over muscle relaxation during surgery. Anesthesiologists use muscle
relaxation to improve surgical conditions and to facilitate intubation and
mechanical ventilation. BRIDION works in an entirely novel way by
encapsulating the muscle relaxant molecule and rendering it inactive,
allowing patients to more rapidly regain muscle function after surgery and
breathe on their own.
BRIDION is approved in the European Union (EU) for reversal of
neuromuscular blockade induced by rocuronium or vecuronium. In children and
adolescents, BRIDION is only recommended for routine reversal of rocuronium
induced blockade.
In the United States, a New Drug Application (NDA) for sugammadex has
been filed with the U.S. Food and Drug Administration (FDA) and assigned
priority review status. The FDA Advisory Committee on Anesthetics and Life
Support in March of this year unanimously recommended approval of
sugammadex. In Japan, a New Drug Application seeking marketing approval of
sugammadex has been filed with the Japanese Ministry of Health, Labour and
Welfare (MHLW) and is currently under review.
Schering-Plough acquired BRIDION (sugammadex) through its combination
with Organon BioSciences in November 2007.
Important Safety Information About BRIDION
BRIDION (sugammadex) should only be administered by or under the
supervision of an anesthesiologist. The use of an appropriate neuromuscular
monitoring technique is recommended to monitor the recovery of
neuromuscular blockade. The use of sugammadex in patients with severe renal
impairment is not recommended.
In clinical trials, the most commonly reported adverse reaction was
metal or bitter taste. Also commonly reported were anesthetic
complications, indicative of the restoration of neuromuscular function,
including movement of a limb or the body or coughing during the anesthetic
procedure or during surgery, grimacing, or suckling on the endotracheal
tube. In a few individuals, allergic-like reactions (i.e. flushing,
erythematous rash) following sugammadex were reported.
About ESMERON
ESMERON (rocuronium bromide) is a non-depolarizing muscle relaxant. It
was introduced in Europe 1994 and is one of the most widely used muscle
relaxants in the United States, Canada (where it is marketed under the
brand name ZEMURON) and many European countries. It was approved for use in
Japan in July 2007 under the brand name ESLAX.
For full Prescribing Information please go to esmeron.
About Schering-Plough
Schering-Plough is an innovation-driven, science-centered global health
care company. Through its own biopharmaceutical research and collaborations
with partners, Schering-Plough creates therapies that help save and improve
lives around the world. The company applies its research-and-development
platform to human prescription and consumer products as well as to animal
health products. Schering-Plough's vision is to "Earn Trust, Every Day"
with the doctors, patients, customers and other stakeholders served by its
colleagues around the world. The company is based in Kenilworth, N.J., USA,
and its Web site is schering-plough.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press
release includes certain "forward-looking statements" within the meaning of
the Private Securities Litigation Reform Act of 1995, including statements
relating to the plans for, the potential of and the potential market for
BRIDION. Forward-looking statements relate to expectations or forecasts of
future events. Schering-Plough does not assume the obligation to update any
forward-looking statement. Many factors could cause actual results to
differ materially from Schering-Plough's forward-looking statements,
including market forces, economic factors, product availability, patent and
other intellectual property protection, current and future branded, generic
or over-the-counter competition, the regulatory process, and any
developments following regulatory approval, among other uncertainties. For
further details of these and other risks and uncertainties that may impact
forward-looking statements, see Schering-Plough's Securities and Exchange
Commission filings, including Item 1A, "Risk Factors" in the company's
first quarter 2008 10-Q.
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