Treatment of Migraine Attacks by Drug Aerosol Inhalation

描述(申请人提供)：偏头痛是影响数百万美国人的一种严重疾病。偏头痛患者强烈希望比目前的药物提供更快的头痛缓解。加速止痛的一个有希望的方法是通过雾化吸入更快地将现有药物输送到体循环。这种快速输送方法的主要技术障碍是产生足够小的颗粒尺寸的IS气雾剂。Alexza的新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夹带剂的情况下生成非常小的颗粒气溶胶。我们的技术已经在FDA的几种药物上被证明是成功的。气雾剂的产生几乎是瞬间发生的，这使其成为吸入给药的理想选择。气雾剂的质量中值空气动力学直径通常约为1微米，这是通过气管和支气管传输并沉积到肺泡的理想尺寸。在赠款的这一阶段，我们将展示将一种或多种治疗偏头痛的药物雾化而不降解或不含杂质的能力，并确认进化后的气雾剂的小颗粒尺寸和体外生物学活性。完成第一阶段的目标将使我们进入第二阶段的研究，并朝着改进的偏头痛治疗方法的商业化迈进。

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.