Zohydro™ ER (hydrocodone bitartrate)
Extended-Release Capsules

INDICATION
Zohydro™ ER is an opioid agonist, extended-release, oral formulation of hydrocodone bitartrate indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

LIMITATIONS OF USE
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve Zohydro ER for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

Zohydro ER is not indicated for use as an as-needed analgesic.

 美国食品药监局（FDA）批准了Zogenix公司关于Zohydro ER（重酒石酸氢可酮缓释胶囊）新药申请（NDA），这是一种用于治疗中重度慢性疼痛的药物。

    Zohydro ER是一种口服新型氢可酮缓释片，药效在12小时内释放。

    Zogenix公司总裁兼首席运营官Srephen Farr说：“获批后Zohydro ER将被药品执法局（DEA）列为第二类药物，将会执行比现在市场上的氢可酮药物更加严格的处方和配药制度。而且Zohydro的上市使得药剂师有了能够治疗中重度慢性疼痛的药物，同时避免由醋氨酚引起的肝损伤。”

    公司提交的NDA申请时基于一个III 期要小研究和一个开放III期安全性研究，有超过1100名慢性病患者参与