英文药名: Lodotra(Prednisone MR)

中文药名: 泼尼松择时释药片

品牌药生产厂家: Merck & Co. Inc.

药品简介

SkyePharma公司合作伙伴Nitec公司的泼尼松择时释药片（prednisone，Lodotra）获得欧盟的上市批准，用于治疗类风湿关节炎及其引起的早晨僵硬。Lodotra是择时细胞素调节剂，清晨安全释放单一小剂量泼尼松。

本品采用SkyePharma公司的Geoclock专利技术制成的特殊片剂，口服后不立即释放泼尼松，而是约在4小时后。Lodotra设计为口服后6小时血药浓度达峰，这可使患者晚上10时口服片剂后睡觉，直到第二日清晨2时释药，4时血药浓度达峰。此时是解除关节僵硬和醒来疼痛的最佳时间。这种晚上服药清晨释药制剂特别适用于治疗类风湿关节炎引起的关节僵硬。

在26个欧洲治疗中心对288例患者进行的Ⅲ期试验已证实，Lodotra于睡前给药与现在推荐的早晨8点给予即释型泼尼松相比较，可显著减轻症状。为期12周的研究观察晨僵的持续时间作为主要终点，显示Lodotra组显著优于标准即释泼尼松组。有半数患者的晨僵持续时间缩短了三分之一(大于1个小时)，疼痛也减轻了三分之一。Lodotra耐受性良好，与标准治疗一样安全。

该控释制剂较糖皮质激素普通制剂改善了对类风湿关节炎的治疗。有研究者表示，“这些结果支持无需增加泼尼松的剂量，只需根据类风湿性关节炎的昼夜节律选择口服糖皮质激素的时间，即可有效治疗类风湿性关节炎的假设”。

Nitec公司还准备在美国上市Lodotra，为向美国FDA递交新药申请正在进行第二项关键的Ⅲ期临床研究。该公司还正研究以泼尼松择时释药片治疗严重的哮喘和风湿性多肌痛。

Lodotra®

Partner: Horizon Pharma, Inc
Lodotra®, the novel programmed-release formulation of low dose prednisone, utilises SkyePharma's proprietary Geoclock™ technology to deliver a chrono-therapeutic approach to help patients with rheumatoid arthritis by reducing early morning stiffness and pain.

Lodotra®, developed in collaboration with Horizon Pharma, is a widely used anti-inflammatory drug for the treatment of moderate to severe rheumatoid arthritis in adults particularly when accompanied by related morning stiffness.

Using SkyePharma’s proprietary Geoclock™ drug delivery technology, prednisone is rapidly released from the tablet core about 4 hours after ingestion. This means that Lodotra® can be conveniently taken at bedtime, and prednisone is released in the early hours of the morning. This allows inhibition of pro-inflammatory cytokine levels when they are at their peak while the patient is sleeping, resulting in significantly less early morning stiffness of the joints.

Horizon received the final assessment report under the European decentralised procedure from the German BfArM in December 2008 and it was approved in Europe in March 2009. Lodotra® is currently approved in 14 European countries as well as in Israel.

Lodotra® was first launched in Germany in April 2009 by Merck Serono (Horizon's previous licensee for Germany and Austria) followed by Italy in January 2011 by Mundipharma (Horizon's distribution partner). In April 2011 Mundipharma acquired the distribution rights for Lodotra® in Germany from Merck Serono and relaunched in this important market with a significantly larger sales force.

In November 2010, Horizon announced it had signed an exclusive distribution and supply agreement with Mundipharma for the commercialisation of Lodotra® in Australia, China, Hong Kong, Indonesia, Korea, Malaysia, New Zealand, Philippines, Singapore, South Africa, Taiwan, Thailand and Vietnam.

In the United States, Horizon has completed two pivotal Phase III studies. The first was a 12-week, randomised, double blind, controlled study against marketed immediate-release prednisone to support MAA approval in Europe. To support the submission of the NDA for the United States, a second 12-week, randomised, double blind, multicentre, placebo controlled study involving 350 patients was undertaken with patients in both treatment arms receiving a disease modifying anti- rheumatic drug ("DMARD"). Both studies met their primary endpoints. 

In September 2011, Horizon submitted the NDA for Lodotra® to the United States Food and Drug Administration (FDA).

Lodotra® is manufactured at the Lyon Manufacturing Facility leased by SkyePharma to Aenova.

包装规格：
1mg  *30  片
2mg  *30  片
5mg  *30 片