2017年8月31日，美国监管机构扩大了梯瓦的Austedo适应证范围，包括治疗成年人的迟发性运动障碍，Austedo最初于2017年4月获得美国批准，是用于治疗与亨廷顿舞蹈病相关的迟发性运动障碍的第一个也是唯一的治疗方法。
迟发性运动障碍是一种衰弱的运动障碍，其特征是舌头，嘴唇，脸部，躯干和四肢的重复性和不可控制的运动，在美国影响约50万人。Austedo（替硝苯那嗪）的扩大适应证批准是基于临床试验数据，该药物显着减少迟发性运动障碍，具有良好的安全性和耐受性。
梯瓦总裁兼首席科学官Hayden表示：我们认为治疗迟发性运动障碍的医生将会了解新治疗方案的灵活性，以及专注于直接治疗运动障碍的能力，而不会妨碍正在进行的基础疾病治疗。监管机构还批准了 Chemo研发公司的苯并咪唑用于查加斯病或美国锥虫病。这是由克氏锥虫引起的寄生虫感染，主要影响生活在拉丁美洲农村地区的人，可以通过不同的途径传播，包括某些昆虫的粪便，输血或怀孕期间母子接触。这种疾病在多年的感染情况下可引起严重的心脏病，也会影响吞咽和消化。FDA 通过其加速批准途径，批准苯硝唑来治疗疾病，为患者提供首例经过认可的疾病治疗方案。
完整说明书附件：
1）：http://druginformation.com/RxDrugs/D/Deutetrabenazine%20Tablets.html
Austedo(Deutetrabenazine Tablets)
AUSTEDO Rx
Generic Name and Formulations:
Deutetrabenazine 6mg, 9mg, 12mg; tabs.
Company:
Teva Pharmaceuticals
Indications for AUSTEDO:
Huntington's chorea. Tardive dyskinesia.
Adult:
Swallow whole. Take with food. Individualize. Chorea: initially 6mg once daily. Dyskinesia: initially 6mg twice daily. Both: may titrate at weekly intervals by 6mg/day increments; max 48mg/day. Total daily dose ≥12mg: give in 2 divided doses. Switching from tetrabenazine: see full labeling. Concomitant strong CYP2D6 inhibitors or poor CYP2D6 metabolizers: max 36mg/day (max 18mg/dose).
Children:
Not established.
Contraindications:
Suicidal, untreated or inadequately treated depression in patients with Huntington's disease. Hepatic impairment. During or within 14 days of discontinuing an MAOI. During or within 20 days of discontinuing reserpine. Concomitant tetrabenazine or valbenazine.
Warnings/Precautions:
Increased risk of depression and suicidality in Huntington's patients; monitor for emergence or worsening of depression, suicidality, or unusual changes in behavior; consider discontinuing if not resolved. Avoid in congenital long QT syndrome or history of cardiac arrhythmias. Assess QT interval before and after dose increases of Austedo ≥24mg/day or other QT-prolonging drugs. Bradycardia. Hypokalemia. Hypomagnesemia. Monitor for neuroleptic malignant syndrome (NMS); discontinue and treat if develops. Reduce dose or discontinue if akathisia or parkinsonism develops. History of breast cancer. Consider discontinuing if symptomatic hyperprolactinemia develops. Reevaluate periodically. Poor CYP2D6 metabolizers. Pregnancy. Nursing mothers.
Interactions:
See Contraindications. Avoid concomitant other drugs that can cause QT prolongation (eg, chlorpromazine, haloperidol, thioridazine, ziprasidone, moxifloxacin, quinidine, procainamide, amiodarone, sotalol). Potentiated by strong CYP2D6 inhibitors (eg, quinidine, paroxetine, fluoxetine, bupropion); see Adult. Increased risk of parkinsonism, NMS, akathisia with dopamine antagonists or antipsychotics. Additive CNS effects with alcohol or other sedatives.
Pharmacological Class:
Vesicular monoamine transporter 2 (VMAT2) inhibitor.
Adverse Reactions:
Somnolence, diarrhea, dry mouth, fatigue, UTI, nasopharyngitis, insomnia; NMS, QTc prolongation, akathisia, agitation, restlessness, parkinsonism, possible ophthalmic effects.
Generic Availability:
NO
How Supplied:
Tabs—60