FDA批准巴氯芬注射液治疗严重痉挛

注射用巴氯芬与口服制剂有同样的标准浓度：50微克/毫升，500微克/毫升和2000微克/毫升，先前获准的口服制剂有分散片，商品名Kemstro；片剂Baclofen。此次获准的注射液通过系鞘内注射给药，商品名Gablofen（SFDA数据库有巴氯芬注射液临床注册信息，2007-2-2受理）。

2010年11月23日，CNS Therapeutics宣布，美国食品药品管理局(FDA)已批准Gablofen (巴氯芬)用于治疗重度脑源性或脊髓源性痉挛。

根据Gablofen的处方信息，该药是一种抑制性神经递质γ-氨基丁酸的结构类似物，适用于通过椎管或腰椎穿刺以单剂试验剂量给药，若长期用药，则可通过使用美敦力公司的SynchroMed II-可编程泵系统或其他标明用于Gablofen鞘内给药的泵系统给药。

FDA批准Gablofen是基于已发表的关于巴氯芬鞘内注射液安全性和疗效的临床数据。脊髓源性痉挛患者使用Gablofen最常见的不良反应是嗜睡、头晕、恶心、低血压、头痛、惊厥和肌张力减退。在脑源性痉挛患者中最常见的不良反应是烦躁不安、便秘、嗜睡、白细胞增多症、寒战、尿潴留和肌张力减退。

无论是何种原因，突然停用巴氯芬鞘内注射液均会产生后遗症，其中包括高热、神志状态改变、痉挛反弹加重和肌强直，有少数病例会进展至横纹肌溶解症、多器官系统衰竭和死亡。

Gablofen包装在即用型药瓶内和预灌封注射器内。使用时需要密切监测以下情况：输注系统的编程与监测、再注满的时间安排与过程以及泵警报器。应告知患者和护理人员保持按时就诊进行再注满的重要性，并应针对巴氯芬撤药后的早期症状对其进行教育。

Gablofen is available in the same standard concentrations (50 mcg/mL, 500 mcg/mL, and 2,000 mcg/mL) as Lioresal®

美国食品药品管理局(FDA)已批准Gablofen (巴氯芬)用于治疗重度脑源性或脊髓源性痉挛。重度痉挛是一种运动障碍，通常与多发性硬化症、脑性瘫痪、脊髓损伤、脑外伤以及卒中有关。

Developed by intrathecal innovators.
Gablofen® (baclofen injection) is indicated for use in the management of severe spasticity of cerebral or spinal cord origin. (See package insert for full prescribing information.) Gablofen is available in the same standard concentrations as Lioresal® Intrathecal (baclofen injection) (50 mcg/mL, 500 mcg/mL, and 2,000 mcg/mL). Each concentration of Gablofen is conveniently packaged to ensure safety, reliability, and efficiency.

Founded by recognized experts in intrathecal medicine, CNS Therapeutics collaborates with industry experts and innovators to develop and refine high-quality, safe, intrathecal drugs. Whether it's rethinking today's intrathecal drugs or exploring promising new treatments for patients, CNS Therapeutics is focused on advancing intrathecal pharmaceuticals.

Stable and compatible with the Medtronic SynchroMed® II Programmable Pump.
Manufactured under strict quality measures (cGMP), all concentrations of Gablofen have met FDA requirements for safety, quality, and stability.

CNS Therapeutics studied pump performance with Gablofen® (baclofen injection) and showed that the Medtronic SynchroMed® II Programmable Pump performed well within the manufacturer's specifications. Stability tests showed Gablofen is stable in the SynchroMed II pump for up to 180 days (6 months). Gablofen is approved only for use with the Medtronic Synchromed® II Programmable pump or other pumps labeled for intrathecal administration of Gablofen® (baclofen injection). Refer to the pump manufacturer’s manual and follow the specific instructions and precautions for programming the pump and/or refilling the reservoir.

Gablofen saves time for clinicians and patients.

Gablofen® (baclofen injection) was designed to ensure the pump refilling process is safe and efficient. From convenient ready-to-use vials to pre-filled syringes, Gablofen packaging improvements are the result of listening to practitioners. Clinicians can reduce drug preparation time for screening doses and pump refills.

It is important to select the appropriate refill kit for the pump used to administer Gablofen. Gablofen is not to be compounded with other medications.

About intrathecal baclofen safety and efficacy.

Gablofen® (baclofen injection) was approved by the FDA based on published clinical data on the safety and efficacy of intrathecal baclofen. In more than 20 years of clinical studies, intrathecal baclofen has been shown to effectively reduce severe spasticity of spinal cord and cerebral origin. Results vary; not every individual will receive the same benefits.

The most common adverse reaction in patients with spasticity of spinal origin were somnolence, dizziness, nausea, hypotension, headache, convulsions, and hypotonia.

The most common adverse reactions in patients with spasticity of cerebral origin were agitation, constipation, somnolence, leukocytosis, chills, urinary retention, and hypotonia.Rare cases of overdose and withdrawal may be life threatening.
About Gablofen stability.
CNS Therapeutics has conducted two-year shelf life testing for Gablofen. Test results varied only slightly over time and remained well within the acceptance criteria.

About Gablofen compatibility with Medtronic SynchroMed® II Programmable Pumps.

The FDA has approved Gablofen only for use in the Medtronic SynchroMed® II Programmable Pump* based on stability testing.

Tests showed that Gablofen is stable in the Medtronic SynchroMed® II Programmable Pump for up to 180 days (6 months). The concentration and amount of degradation of Gablofen in the pump varied only slightly and remained within the acceptance criteria during this time period.

At the end of the 180 day test, CNS Therapeutics studied pump performance with Gablofen and showed that Medtronic SynchroMed® II Programmable Pumps performed well within the manufacturer's specifications.

* or other pumps labeled for intrathecal administration of
Gablofen® (baclofen injection)