FDA同意扩大Actavis二代安定剂药物适用范围

制药巨头Actavis公司最近宣布FDA已经批准公司开发的新型安定剂药物Saphris的适用人群范围由此前的成年第一型双极性情感障碍（bipolar I disorder）和精神分裂症患者扩大至患有第一型双极性情感障碍的青少年患者群体（10岁-17岁）。

目前数据显示，美国共有120万名青少年患有这种疾病。Saphris是Actavis公司开发的第二代安定剂类药物，并于2009年获得FDA批准上市，患者主要通过舌下含服的方式接受治疗。这也是FDA最近五年来批准的首个用于青少年第一型双极性情感障碍患者的非典型抗精神病药物。

根据Actavis公司提供的数据，Saphris能够显着显著改善青少年第一型双极性情感障碍患者在杨氏躁狂量指数等参数。这也是FDA做出这一决定的基础。公司计划于2015年第二季度推出青少年用Saphris，其药物剂量包括2.5mg、5mg和10mg三种。

所谓的非典型抗精神病药物既我们通常所说的第二代抗精神病药物。美国NIH的研究发现这类药物，相比于第一代抗精神病药物，造成患者迟发性运动障碍的风险更低。因而也更为安全。

不过，使用这类药物时，患者仍需注意自身的血糖和血脂水平。目前FDA共批准了11种非典型抗精神病药物，其中绝大部分都是口服药物。许多制药巨头在这一领域也有自己的拳头产品。如辉瑞公司的Geodon，礼来公司的Zyprexa以及百时施贵宝公司和日本大冢医药公司共同拥有的Abilify等。此次，FDA做出的这一决定，无疑也有利于青少年患者选择更适合他们的疗法。（生物谷Bioon.com）

详细英文报道：

The FDA has expanded the indication of the only sublingual atypical, or second-generation, antipsychotic to include pediatric patients aged 10 to 17 with bipolar I disorder.

Actavis' ($ACT) Saphris tablet, which is delivered via placement under the tongue, was approved in 2009 to treat bipolar I disorder and schizophrenia in adults. The new development adds 1.2 million U.S. children and teens to the potential market for the medication, Actavis says.

"We were pleased to see that Saphris was effective across a range of doses, in the largest registrational pediatric trial for an atypical antipsychotic in bipolar I disorder," said the company's executive vice president of global R&D, David Nicholson, in a statement. "Saphris is the first atypical antipsychotic to be approved for pediatric patients with bipolar I disorder in the last five years. As part of our commitment to mental health, we look forward to making this treatment option available to patients as soon as possible."

The company said the med resulted in improvement in scores on the Young Mania Rating Scale and Clinical Global Impression-Bipolar Severity of Illness assessments as compared with placebo in the pediatric clinical trial.

Saphris for pediatrics will be available as a 2.5-mg, 5-mg or 10-mg sublingual tablet in the black cherry flavor in Q2 2015.

Eleven atypical antipsychotic medications are available, according to the FDA. All are delivered orally, except sublingual Saphris. Pfizer's ($PFE) Geodon, Eli Lilly's ($LLY) Zyprexa and Otsuka's Abilify (co-marketed with Bristol-Myers Squibb) have injectable versions for intramuscular delivery as well.

Atypical antipsychotics are also known as second-generation antipsychotics. The National Institutes of Health says the second-generation meds are less likely to result in tardive dyskinesia, which results in uncontrollable muscle movements, than those of older, so-called typical antipsychotics. But the agency notes that people on the newer generation of meds should monitor their weight, glucose levels and lipid levels.