PHILADELPHIA, June 13, 2017 /PRNewswire/ --
A study sponsored by BTG plc (LSE: BTG), the global specialist
healthcare company, has been recently published in the Annals of
Emergency Medicine (AEM) that shows administering
CroFab® to patients envenomated by copperhead snakes can
aid the recovery of a patient's affected limb function as compared
with placebo.
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The randomised, double-blind, placebo-controlled study compared
CroFab® Crotalidae Polyvalent Immune Fab (Ovine) - the
only antivenom currently marketed for the treatment of crotaline
snake envenomation - against placebo for the treatment of
copperhead snake envenomation for the first time.
Copperhead envenomation is generally considered less severe than
other North American Pit Viper
snakebites, but more than 95% of copperhead victims still develop
significant pain and swelling of the injured limb, and other soft
tissue injury. Most patients resume activities within 2-4 weeks but
residual symptoms can last for a year.
Dr Charles Gerardo, Chief of
Emergency Medicine at Duke University
and expert in Copperhead snake envenomation, said: "For the first
time, this data demonstrates that CroFab® improves
recovery of limb function from Copperhead envenomation.
Additionally, antivenom treatment was associated with less opioids
use throughout the patient's recovery. These results can be used to
help physicians and patients make a more informed choice about
their care."
In total, 74 patients participated in the study; 45 were treated
with CroFab® and the rest received a placebo. All
participating trial staff (apart from the study pharmacist) and
patients were unaware of the treatment given in each case. Within
the patient cohort was a mix of upper and lower extremity
conditions depending on where the copperhead had bitten the
patient.
The Patient Specific Functional Scale (PSFS) was used to measure
study outcomes by assessing each patient's ability to do daily
activities that they were unable to do or had difficulty with post
copperhead inflicted injury. The tasks varied from driving a car,
climbing the stairs, brushing teeth, or using a cell phone and took
in to account the score at envenomation + 14 days using a 0-10
scale. In addition to the positive primary outcome of the study, it
was also discovered that opioid analgesic use was less in
CroFab® treated patients.
Dan Schneider, SVP and General
Manager, Specialty Pharmaceuticals, Commercial Operations at BTG,
said: "We are pleased with the clinical study findings that show
that patients treated with CroFab® recover faster from
Copperhead bites. Even though we haven't reached summer months
yet, we are seeing multiple reports stating that the frequency of
bites in the U.S. are on the rise this year. As snake sightings
start to pick up, don't forget to download our free, educational
SnakeBite911™ App Suite. It has
useful information about the dos and don'ts if envenomation occurs
and helps raise awareness about North American Pit Vipers."
To review the published article in full, please refer to the
following link:
http://www.annemergmed.com/article/S0196-0644(17)30510-3/fulltext.
Indication
CroFab® Crotalidae Polyvalent Immune Fab (Ovine) is a
sheep-derived antivenin indicated for the management of adult and
pediatric patients with North American crotalid envenomation. The
term crotalid is used to describe the Crotalinae subfamily
(formerly known as Crotalidae) of venomous snakes which includes
rattlesnakes, copperheads and cottonmouths/water moccasins.
Important Safety Information
The most common adverse reactions reported in the clinical
studies were urticaria, rash and nausea. Adverse reactions
involving the skin and appendages (primarily rash, urticaria, and
pruritus) were reported in 12 of the 42 patients. Two patients had
a severe allergic reaction (severe hives and a severe rash and
pruritus) following treatment and one patient discontinued CroFab®
due to an allergic reaction. Anaphylaxis and hypersensitivity
reactions can occur, and patients should be monitored closely
during treatment. CroFab® should not be administered to patients
with a known history of hypersensitivity to papaya or papain unless
the benefits outweigh the risks and appropriate management for
anaphylactic reactions is readily available.
In clinical trials, recurrent coagulopathy (the return of a
coagulation abnormality after it has been successfully treated with
antivenin), characterized by decreased fibrinogen, decreased
platelets and elevated prothrombin time, occurred in approximately
half of the patients studied; one patient required
rehospitalization and additional antivenin administration.
Recurrent coagulopathy may persist for 1 to 2 weeks or more.
Patients who experience coagulopathy due to snakebite should be
monitored for recurrent coagulopathy for up to 1 week or longer.
During this period, the physician should carefully assess the need
for re-treatment with CroFab® and use of any type of anticoagulant
or anti-platelet drug.
About BTG
BTG is a global specialist healthcare company bringing to market
innovative products in specialist areas of medicine to better serve
doctors and their patients. We have a portfolio of Interventional
Medicine products to advance the treatment of cancer, severe
emphysema, severe blood clots and varicose veins, and Specialty
Pharmaceuticals that help patients overexposed to certain
medications or toxins. Inspired by patient and physician needs, BTG
is investing to expand its portfolio to address some of today's
most complex healthcare challenges. To learn more about BTG, please
visit: btgplc.com.
For further information contact:
BTG
Andy Burrows, VP Corporate &
Investor Relations
+44-(0)-20-7575-1741
Mobile: +44-(0)-7990-530-605
Stuart Hunt, Investor Relations
Manager
+44-(0)-20-7575-1582
Mobile: +44-(0)-7815-778-536
Chris Sampson, Corporate
Communications Director
+44-20-7575-1595
Mobile: +44-7773-251-178
FTI Consulting
Ben Atwell/Simon Conway
+44-(0)-20-3727-1000
SOURCE BTG Plc