Migraine Headache Treatment by Drug Aerosol Inhalation

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.