Press Release
<p>FERRING PHARMACEUTICALS ANNOUNCES EUFLEXXA™ LABELING EXTENDED TO INCLUDE ROOM TEMPERATURE STORAGE</p>
<p><strong>CONTACT:</strong> Tara Fisher <strong>FOR IMMEDIATE RELEASE</strong><br/>
Kovak-Likly Communications<br/>
203-762-8833, tfisher@klcpr.com </p>
<p><strong>EUFLEXXA™ LABELING EXTENDED TO INCLUDE ROOM TEMPERATURE STORAGE</strong><br/>
<strong>Ferring Debuts New Product Labeling at AAOS Annual Meeting</strong> </p>
<p>Suffern, NY – April 10, 2006 – Ferring Pharmaceuticals Inc.
announced recently that the U.S. Food and Drug Administration (FDA)
has approved the Premarket Application (PMA) supplement for EUFLEXXA™
(highly purified hyaluronan) that allows the product to be stored at
room temperature, as well as refrigerated. EUFLEXXA™ is a three-injection
treatment given by physicians for the pain caused by knee osteoarthritis
(OA). The new labeling was introduced to the medical community at the
American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting in Chicago,
March 22-26, and product reflecting this label extension is now available
to the public. </p>
<p>EUFLEXXA™ has been extremely well received by physicians and patients
alike since it was introduced in November 2005,” said Wayne Anderson,
President, Ferring Pharmaceuticals Inc. “Patients are finding relief
from the pain of knee osteoarthritis for the first time, after other
first line treatments have failed. In fact, a head-to-head study showed
that EUFLEXXA™ offers better symptom-free relief from knee OA pain than
Synvisc<sup>®</sup>, the market-leading HA therapy, with less use of simple
analgesics and a lower incidence of joint effusion.1 This new labeling
makes it easier for physicians to store EUFLEXXA™ and keep it available
for patients. </p>
<p>In conjunction with this extension, the shelf life of EUFLEXXA™ will be
12 months. The newly labeled product will be designated by the same
product code (sometimes referred to as NDC/HRI #) 55566-4100-1. </p>
<p><strong>About EUFLEXXA™</strong><br/>
EUFLEXXA™ (1% sodium hyaluronate) is the first and only non-avian
derived* hyaluronic acid approved in the U.S. for the treatment of
pain caused by knee osteoarthritis and is indicated for a
three-injection treatment regimen for patients who have failed to
respond adequately to conservative non-pharmacologic therapy and
simple analgesics. Since it is not derived from an avian source
(chicken or rooster combs), the risk of related reactions is
eliminated. <sup>2,3</sup> In addition, EUFLEXXA™ has
properties similar to the HA in healthy human synovial fluid
and is free of chemical cross-linking which minimizes the risk
of related reactions.<sup>2-7</sup> </p>
<p>EUFLEXXA™ received approval from the U.S. Food and Drug Administration
(FDA) on December 3, 2004, and became available to the public on
November 8, 2005. For more information, visit www.EUFLEXXA.com. </p>
<p><strong>About Hyaluronic Acid</strong><br/>
HA is a viscous, elastic liquid that is naturally found in many
tissues of the body and in high concentrations in synovial fluid.
Within a joint, HA is essential to water balance, viscosity,
lubrication and the structure of cartilage.<sup>8</sup> In synovial fluid,
HA binds to other molecules, helping it withstand weight-bearing
force and movement of the joint. Inside the knee joint, HA provides
a cushion to protect the joint from mechanical damage and acts as
both a shock-absorbing fluid and regulator of water and metabolites. </p>
<p><strong>Osteoarthritis and the General Population</strong><br/>
The Arthritis Foundation estimates that 66 million Americans are
affected by arthritis, half of whom are unaware of available
treatments, and that the disease costs the U.S. economy more
than $86.2 billion annually. The Foundation also estimates that
21 million American adults suffer from osteoarthritis.<sup>9</sup>
Osteoarthritis, a form of arthritis, affects certain parts of
the body, most commonly the knee. Over time, articular cartilage
in the knee loses elasticity and becomes worn. As a result, the
bony surfaces of the joint can grind together and eventually
wear the cartilage away entirely. This leads to symptoms of
pain, stiffness and impaired joint movement. There is a wide
range of treatment options for knee OA, including behavior
modification, drug therapy, injections within the joint and
knee replacement surgery. </p>
<p>Non-steroidal anti-inflammatory drugs (NSAIDs) are common first-line
pharmacologic treatments for knee pain relief. Serious side effects and risks
(ie. potentially life-threatening stomach bleeding and kidney disease)
have been associated with such treatments. </p>
<p>The effectiveness of different treatments varies from
person-to-person and with the severity of the condition.
Treatment options are generally a shared decision
between the patient and his/her physician with total
knee replacement surgery usually sought as the last option. </p>
<p><strong>About Ferring Pharmaceuticals Inc.</strong><br/>
Ferring Pharmaceuticals Inc., part of the Ferring Group,
is a privately owned, international pharmaceutical company.
Ferring’s line of orthopaedic and urology products include
EUFLEXXA™, hyaluronic acid for the treatment of pain from
osteoarthritis of the knee and degarelix for prostate
cancer (Phase III). </p>
<p>Ferring also markets MENOPUR<sup>®</sup> (menotropins for injection, USP),
BRAVELLE<sup>®</sup> (urofollitropin for injection, purified), REPRONEX<sup>®</sup>
(menotropins for injection, USP) and NOVAREL<sup>®</sup> (chorionic
gonadotropin for injection, USP) in the U.S. to infertility
specialists and their patients. Ferring offers the Q·CAP™,
the first and only needle-free reconstitution device, for
use with its fertility treatments. </p>
<p>Other products include ACTHREL<sup>®</sup> (corticorelin ovine triflutate
for injection) for the differential diagnosis of Cushing’s
syndrome and desmopressin acetate in injectable and rhinal
tube forms for the treatment of diabetes insipidus and primary
nocturnal enuresis.</p>
<p>The Ferring Group specializes in the research, development and
commercialization of compounds in general and pediatric
endocrinology, urology, gastroenterology, obstetrics/gynecology
and infertility. For more information, visit www.FerringUSA.com. </p>
<p># # # </p>
<p>* Derived through bacterial fermentation<br/>
<i>EUFLEXXA is a trademark of Ferring Pharmaceuticals Inc.</i><br/>
<i>Synvisc is a registered trademark of Genzyme Corporation.</i> </p>
EUFLEXXA (1% sodium hyaluronate) is used to relieve knee pain due to osteoarthritis. It is used in people who do not get enough relief from simple pain medications such as acetaminophen or from exercise and physical therapy.
Important Safety Information
You should not receive this product if you have had any previous allergic reaction to EUFLEXXA or hyaluronan products. You should not have an injection into the knee if you have a knee joint infection or if you have skin disease or infection around the injection site.
EUFLEXXA is only for injection into the knee performed by a qualified doctor. After you receive this injection you may need to avoid activities such as jogging, tennis, heavy lifting, or standing on your feet for a long time (more than one hour). The safety and effectiveness of repeat treatment cycles of EUFLEXXA have not been established. The safety and effectiveness of EUFLEXXA have not been shown in people under 18 years of age.
Side effects sometimes seen when EUFLEXXA is injected into the knee joint were pain, swelling, skin irritation, and tenderness and these were generally mild and did not last long.
Please see Full Prescribing Information.
Please see Important Information for Patients.
PLEASE CONSULT WITH YOUR DOCTOR, OR OTHER QUALIFIED HEALTH CARE PROFESSIONAL BEFORE USING ANY PRODUCT DISCUSSED WITHIN THIS WEB SITE.
This website is intended only for US residents.
Euflexxa® is a registered trademark of Ferring Pharmaceuticals Inc.
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