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.
