ST LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has granted marketing approval for Synvisc-One (hylan G-F 20), a product for the relief of pain associated with osteoarthritis (OA) of the knee.

Synvisc-One is the only single-injection viscosupplement approved for treating OA knee pain in the United States. This therapy has the potential to extend the benefits of this therapeutic approach to a broader set of patients and reduce the total cost of multiple injections.

"In just one visit to the doctor's office, patients suffering from osteoarthritis may experience clinically significant pain relief for up to 6 months, and for some patients this pain relief could potentially translate into a delay in the need for a total knee replacement," said Jack M. Bert, MD, president of the Arthroscopy Association of North America and adjunct clinical professor at the University of Minnesota School of Medicine. "This single injection regimen will provide greater physician and patient convenience."

Synvisc-One is administered through a single intra-articular injection. It is an alternative treatment regimen to Genzyme's Synvisc (hylan G-F 20), a 3-injection viscosupplement approved in the United States in 1997 and in use worldwide for more than 16 years. Synvisc-One contains the same material and total treatment volume as Synvisc but provides the 6 mL of hylan G-F 20 in a single injection.

Viscosupplementation is a procedure in which hyaluronic acid or a derivative such as hylan G-F 20 is injected into the knee joint to replace synovial fluid that typically becomes degraded in patients with osteoarthritis. In synovial fluid, hyaluronic acid relieves pain and improves the knee joint's natural shock-absorbing abilities.

For full prescribing information, see www.synvisc-one.com.
 

圣路易斯(MD Consult)——美国FDA批准了Synvisc-One(hylan G-F 20)的上市许可。Synvisc-One是用于缓解膝关节骨关节炎(OA)相关性疼痛的药物。

Synvisc-One是目前美国批准治疗膝关节骨关节炎相关性疼痛的唯一一种单次注射的黏弹性填充物。该药的问世有望使更多患者从黏弹性物填充疗法中获益，同时还可降低多次注射的总费用。

“只需一次注射，骨关节炎患者就可以获得长达6个月的临床效果显著的疼痛缓解，而且对于某些患者来说，这种疼痛缓解可以延缓其进行全膝关节置换术，”北美关节镜学会主席、明尼苏达大学医学院临床教授Jack M. Bert博士说，“这种单次注射方案将使医师和患者双方都获得便利。”

Synvisc-One为单次关节腔内注射给药。它是Genzyme公司Synvisc (hylan G-F 20)的替代治疗方案，后者是一种注射三次的黏弹性补充物，于1997年在美国获准上市，在全球范围内已有超过16年的应用历史。Synvisc-One含有Synvisc的同样有效成分，总治疗体积也与Synvisc相同，只是将6 ml的hylan G-F 20一次性注射给药。

黏弹性补充疗法是一种将透明质酸或其衍生物如hylan G-F 20注入膝关节以替代滑液的治疗方法。骨关节炎患者的滑液通常变得稀薄，透明质酸浓度下降。在关节滑液中，透明质酸充当缓解疼痛和增强膝关节自然减震能力的角色。

更多处方信息，可参阅下列网站：www.synvisc-one.com

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