Press Release
<p>FERRING PHARMACEUTICALS UNVEILS SIX-MONTH EFFICACY DATA FOR EUFLEXXA<sup><sup>®</sup></sup> FOR THE TREATMENT OF OSTEOARTHRITIS KNEE PAIN</p>
<p><strong>Results Show Superior Decrease in Pain Scores Compared to Saline</strong></p>
<p><strong>PARSIPPANY, NJ – May 13, 2009 –</strong> Ferring Pharmaceuticals recently presented the results of a six-month safety and efficacy study demonstrating that EUFLEXXA<sup>®</sup> (1% sodium hyaluronate) was effective at decreasing the pain of knee osteoarthritis (OA) at 26 weeks. The study showed that EUFLEXXA <sup>®</sup> is superior to saline in decreasing pain at 26 weeks in patients with OA of the knee.<sup>1</sup> The study results were presented by Dr. Roy D. Altman in a poster at the Annual Meeting of the American Academy of Orthopedic Surgeons on February 23, 2009. EUFLEXXA<sup>®</sup> is a three-injection treatment regimen indicated for patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics. The goal of hyaluronic acid (HA) therapy is to reduce pain and improve physical function by replenishing the HA in human synovial fluid (fluid in joints). In OA, this fluid becomes thinner, leading to a decrease in elasticity and viscosity.</p>
<p><strong>About the Study</strong></p>
<p>The multicenter, 26-week, randomized, double-blind trial compared EUFLEXXA<sup>®</sup> and intra-articular buffered saline (IA-SA) for level of pain following a 50-Foot Walk Test, measured by 100 mm visual analog scale (VAS). The 586 patients with chronic idiopathic knee OA were randomized to treatment with either product in a 1:1 ratio. Each patient received one weekly
injection for 3 weeks with 9 follow-up visits over 26 weeks after the first injection. The EUFLEXXA<sup>®</sup> group showed an advantage over saline in pain reduction, with a larger mean decrease from baseline in pain scores: -25.7 (28.9) mm versus -18.5(32.5) mm respectively, with a least squares means of -6.6 mm (P=0.002). At 26 weeks, 145 (58%) of EUFLEXXA<sup>®</sup> subjects reported a ≥20-mm improvement in pain based on the VAS scoring, compared with 120 (46%) in the other group (P=0.006). The percentage of Osteoarthritis Research Society International (OARSI) responders for the EUFLEXXA<sup>®</sup> group was also significantly greater than that in the other group (67% versus 59% (P=0.047). A subject is considered a responder if there is a high improvement in pain or function, or improvement in at least two of the following three categories: pain ≥20% and absolute change ≥10 mm, function ≥20% and absolute change ≥10 mm, and/or patient global assessment ≥20% and absolute change.</p>
<p><strong>About EUFLEXXA<sup>®</sup></strong></p>
<p>EUFLEXXA<sup>®</sup> (1% sodium hyaluronate) is the first non-avian derived* hyaluronic acid (HA) approved in the U.S. for treatment of knee pain due to osteoarthritis (OA). EUFLEXXA<sup>®</sup> is indicated for patients who have failed to get adequate pain relief either from simple pain medications, such as acetaminophen, or from exercise and/or physical therapy. The process used to manufacture EUFLEXXA<sup>®</sup> results in highly-purified HA with properties similar to the HA in healthy human synovial fluid.<sup>2-4</sup> EUFLEXXA<sup>®</sup> 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 <a href="http://www.euflexxa.com" target="_blank">www.EUFLEXXA.com</a>.</p>
<p>EUFLEXXA<sup>®</sup> should not be used in people who have had any previous allergic reaction to hyaluronate preparations or who have knee joint infections or skin diseases in the area of the injection site. Common adverse events reported were arthralgia (joint pain) and back pain. Temporary knee pain and swelling may occur after injection. Strict aseptic technique must be followed to avoid joint infection.</p>
<p><strong>About Ferring Pharmaceuticals Inc.</strong></p>
<p>Ferring Pharmaceuticals Inc. is a subsidiary of Ferring Pharmaceuticals, a privately owned, international pharmaceutical company. Ferring Pharmaceuticals offers a line of infertility, urology, and orthopaedic products in the U.S. market. They include: BRAVELLE<sup>®</sup> (urofollitropin for injection, purified), MENOPUR<sup>®</sup> and REPRONEX<sup>®</sup> (menotropins for injection, USP), NOVAREL<sup>®</sup> (chorionic gonadotropin for injection, USP), ENDOMETRIN<sup>®</sup> (progesterone) Vaginal Insert,100 mg, PROSED<sup>®</sup> DS methenamine, phenyl salicylate, methylene blue, benzoic acid, hyoscyamine sulfate), DESMOPRESSIN, DEGARELIX for injection and EUFLEXXA<sup>®</sup> (1% sodium hyaluronate).</p>
<p>Ferring Pharmaceuticals specializes in the research, development and commercialization of compounds in general and pediatric endocrinology, urology, orthopaedics, gastroenterology, obstetrics/gynecology, and infertility. For complete prescribing information, call 1-888-FERRING (1-888-337-7464) or visit <a href="http://www.ferringusa.com" target="_blank">www.FerringUSA.com</a>.</p>
<p>*Derived through bacterial fermentation</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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