Migraine Headache Treatment by Drug Aerosol Inhalation

描述（由申请人提供）：偏头痛是一种影响数百万美国人的严重疾病。偏头痛患者强烈希望比目前的药物提供更快速的头痛缓解。加速缓解疼痛的一个有希望的方法是通过气溶胶吸入将现有药物更快地输送到体循环。在这项资助的第一阶段，Alexza MDC展示了形成几种领先偏头痛药物的高纯度，小颗粒尺寸气溶胶的能力。此外，我们已经证明了快速、可靠的全身吸收和药物作为这种气雾剂给狗的药理活性的快速发作。在第二阶段，我们将进行毒理学研究，以启动这种速效吸入式偏头痛药物的人体试验。此外，我们将优化输送装置的便利性和可靠性，并生产足够数量的手持式、呼吸驱动的输送装置，进行人体安全性和耐受性试验。二期目标的实现将直接导致一种商业上可行的设备的人体临床试验，每年可以改善数百万人的生活。

DESCRIPTION (provided by applicant): Migraine is a serious condition affecting millions of Americans. Patients with migraine strongly desire more rapid headache relief than current medications provide. A promising approach to expediting pain relief is delivery of existing drugs to the systemic circulation more rapidly via aerosol inhalation. In Phase I of this grant, Alexza MDC demonstrated the ability to form high purity, small particle size aerosols of several leading migraine medications. In addition, we have demonstrated rapid, reliable systemic absorption and quick onset of pharmacological activity of drug delivered as such aerosols to dogs. In Phase II, we will conduct the toxicology studies required to initiate human trials of such a fast-acting, inhaled migraine medication. In addition, we will optimize the convenience and reliability of the delivery device, and produce a sufficient supply of handheld, breath-actuated delivery devices to carryout a human safety and tolerability trial. Accomplishment of the goals of Phase II will lead directly to human clinical testing of a commercially viable device that could improve the lives of millions of people every year.