2019年11月25日,Aquestive Therapeutics，Inc宣布，美国食品和药物管理局 (FDA) 已批准 Exservan（利鲁唑口服膜；Aquestive Therapeutics）用于治疗肌萎缩侧索硬化症（ALS）。
  该批准是基于证明 Exservan 口服薄膜与口服利鲁唑片的生物等效性的药代动力学研究。利鲁唑在ALS患者中发挥治疗作用的机制尚不清楚，但临床研究表明，它通过抑制谷氨酸释放和突触后谷氨酸受体信号传导来调节谷氨酸神经传递。
  Aquestive首席执行官 Keith J. Kendall 说：“我们预计Exservan通过我们的口服PharmFilm剂型，将为被诊断患有ALS并面临吞咽或服用传统药物困难的患者带来有意义的治疗。”
每片口服薄膜含有50mg利鲁唑，采用独立袋包装，每箱60袋。口腔薄膜涂在舌头上，在那里它粘附和溶解。
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Exservan™ (riluzole oral film) is now available for the treatment of amyotrophic lateral sclerosis (ALS).
Generic Name & Formulations:
Riluzole 50mg; oral films.
Company:
Mitsubishi Tanabe Pharma America
Miscellaneous neurodegenerative disorders:
Indications for: EXSERVAN
Amyotrophic lateral sclerosis (ALS).
Adult Dosage:
Take ≥1hr before or 2hrs after a meal. Dissolve on tongue and swallow. 50mg twice daily.
Children Dosage:
Not established.
EXSERVAN Warnings/Precautions:
Monitor for hepatic injury monthly for the first 3 months, and periodically thereafter. Measure serum aminotransferases before and during treatment. If ALT >5×ULN: not recommended. Discontinue if liver dysfunction evident (eg, elevated bilirubin). Risk of neutropenia: monitor for febrile illness. Discontinue immediately if interstitial lung disease develops. Japanese patients (higher drug concentration/adverse reactions). Hepatic impairment. Elderly. Pregnancy. Nursing mothers.
EXSERVAN Classification:
Benzothiazole.
EXSERVAN Interactions:
May be potentiated by strong or moderate CYP1A2 inhibitors (eg, ciprofloxacin, enoxacin, fluvoxamine, methoxsalen, mexiletine, oral contraceptives, thiabendazole, vemurafenib, zileuton). May be antagonized by CYP1A2 inducers. Increased risk of hepatotoxicity with concomitant other hepatotoxic agents (eg, allopurinol, methyldopa, sulfasalazine).
Adverse Reactions:
Oral hypoesthesia, asthenia, nausea, decreased lung function, hypertension, abdominal pain; elevated ALTs, severe neutropenia, interstitial lung disease, hypersensitivity pneumonitis.
Generic Drug Availability:
NO
How Supplied:
Oral films—60