FDA Approves Longer Duration Efficacy and Safety for EUFLEXXA®
PARSIPPANY, N.J., Oct. 21, 2011 /PRNewswire/ -- On Oct. 11, 2011, the FDA approved a labeling supplement for EUFLEXXA (1% sodium hyaluronate) that provides 26-week efficacy data from the FLEXX trial, as well as, 52-week safety data to demonstrate the safety of repeated injection cycles.
The FLEXX trial was a 26-week multicenter, randomized, double-blind study evaluating the safety and efficacy of EUFLEXXA, compared with saline, in patients with painful osteoarthritis of the knee. Patients received three weekly injections of either EUFLEXXA or saline into the target knee. Following the double-blind portion of the trial, patients were offered to receive an additional three weekly injections of EUFLEXXA in a 26-week open-label safety extension. Results from the double-blind portion of the study showed patients treated with EUFLEXXA had a statistically and clinically significant decrease in osteoarthritis knee pain compared to those who received saline control injections as measured by a 50-foot walk test at week 26.
The number of patients reporting adverse events was generally similar between the EUFLEXXA and saline groups. The most common adverse events (>2%) reported in patients treated with EUFLEXXA were: arthralgia, hypertension, back pain, upper respiratory tract infection, diarrhea, injury and cough. In addition, results of the open-label extension demonstrated that repeated injection cycles of EUFLEXXA were well-tolerated up to 52 weeks. In this open-label portion of the study, the most commonly reported adverse events (>2%) were: arthralgia, nasopharyngitis, injury, back pain, joint swelling, upper respiratory tract infection and sinusitis.
"The results further support EUFLEXXA as the first bioengineered, non-avian, effective treatment option that provides osteoarthritis knee pain relief lasting up to six months. The labeling also reflects safety with repeated injection cycles," said Dr. Paul Korner, Senior Vice President, U.S. Development, Ferring Pharmaceuticals. "Ferring is committed to taking a leadership role in the research and development of osteoarthritis therapies. We are very pleased to provide ongoing scientific support and differentiation for EUFLEXXA and are gratified by the FDA approval."
About the Study: FLEXX Trial and FLEXX Trial Extension
The FLEXX trial enrolled 588 patients with osteoarthritis of the knee experiencing moderate to severe joint pain. Patients were randomized to either receive EUFLEXXA (n=293) or a saline control (n=295). At week 26, patients treated with EUFLEXXA had a -25.7 millimeter mean reduction in knee pain scores (based on a 100 millimeter visual analog scale) compared to a -18.5 millimeter mean reduction in knee pain scores for patients treated with the saline control injections. The group difference in least squares mean change from baseline of -6.6 millimeter (95% CI = -10.8 to -2.5 millimeter) was statistically significant (p-value = 0.002).
Following completion of the 26-week double-blind phase of the FLEXX trial, 433 patients continued on to the 26-week extension where they received three weekly EUFLEXXA injections (219 patients previously received EUFLEXXA and 214 patients previously received the saline control). The results of this open-label extension demonstrated that repeated injection cycles of EUFLEXXA were well-tolerated up to 52 weeks.
About EUFLEXXA (1% sodium hyaluronate)
EUFLEXXA is a bioengineered, non-avian product used to relieve osteoarthritis knee pain. 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 a skin disease or infection around the injection site.
EUFLEXXA is only for injection into the knee preformed by a qualified doctor or healthcare professional. After you receive this injection you may need to avoid physical activities for 48 hours such as jogging, tennis, heavy lifting or standing on your feet for more than one hour at a time. The safety and efficacy of EUFLEXXA has not been established in pregnant women, women who are nursing, or in children less than 18 years of age.
The most common adverse events and symptoms that occurred during clinical studies of EUFLEXXA were: pain in the knee or at the injection site and stiffness, swelling or warmth in or around the knee.
About Ferring Pharmaceuticals Inc.
Ferring Pharmaceuticals Inc. is a subsidiary of Ferring Pharmaceuticals, a privately owned, international pharmaceutical company. Ferring Pharmaceuticals offers a line of products in the U.S. market. They include: BRAVELLE® (urofollitropin for injection, purified), MENOPUR® (menotropins for injection, USP) and REPRONEX® (menotropins for injection, USP), NOVAREL® (chorionic gonadotropin for injection, USP), ENDOMETRIN® (progesterone) Vaginal Insert, LYSTEDA® (tranexamic acid tablets), FIRMAGON® (degarelix for injection), and EUFLEXXA® (1% sodium hyaluronate).
Ferring Pharmaceuticals specializes in the research, development and commercialization of compounds in general and pediatric endocrinology, gastroenterology, infertility, obstetrics/gynecology, orthopaedics and urology. For more information, call 1-888-FERRING (1-888-337-7464) or visit www.FerringUSA.com.
All registered trademarks above are owned by Ferring B.V.
SOURCE Ferring Pharmaceuticals Inc.