Treatment of Migraine Attacks 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的头痛缓解。加速疼痛缓解的一种有前途的方法是通过雾化吸入将现有药物更快地递送到体循环。这种快速递送方法的主要技术障碍是产生足够小粒径的气雾剂。ALEXZA的新型气溶胶生成方法克服了这一障碍，该方法可以在不使用任何赋形剂或赋形剂的情况下产生非常小的颗粒气溶胶。我们的技术已经被证明在几种FDA药物上是成功的。气雾剂的产生几乎是瞬间发生的，使其成为理想的吸入药物递送。气溶胶的质量中值空气动力学直径通常为约1微米，这是通过气管支气管气道传输并沉积到肺泡上的理想尺寸。在资助的这一阶段，我们将展示雾化一种或多种治疗偏头痛的药物而不降解或杂质的能力，并确认所产生的气雾剂的小粒径和体外生物活性。第一阶段目标的完成将使我们进入第二阶段研究，并朝着改善偏头痛治疗的商业化方向发展。

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. The major technical hurdle in this rapid delivery approach is generation of is aerosols of sufficiently small particle size. This obstacle is overcome by ALEXZA's novel aerosol generation approach, which can produce very small particle aerosols without using any excipients or entrainers. Our technique has already proven to be successful on several FDA drugs. Production of the aerosol occurs nearly instantaneously, making it ideal for inhalation drug delivery. The mass median aerodynamic diameter of the aerosol is typically about one micron, an ideal size for transmission through the tracheobronchial airways and deposition onto the alveoli. In this phase of the grant, we will demonstrate the ability to aerosolize one or more drugs for migraine without degradation or impurities and confirm the small particle size and in vitro biological activity of the evolved aerosol. Completion of the aims of Phase I will launch us into Phase II studies and towards the commercialization of an improved migraine treatment.