SBIR Phase I: Dissolvable microneedle study for migraine therapy

This Small Business Innovation Research (SBIR) Phase I project aims to develop a novel sumatriptan delivery method for effective migraine therapy. Migraine is a chronic headache pain, typically lasting for up to 24 hours. Sumatriptan aborts more than 80% of migraines within two hours if it is used early in the course of an attack. Therefore, there is a huge demand for new delivery methods to achieve a rapid initial onset and sustained plasma concentration of sumatriptan. TheraJect's sumatriptan patch employs<1 mm long "needles" made of dissolvable materials (e.g. sugar) impregnated with a drug (e.g. sumatriptan). Applied to the skin like a Band-Aid, the microneedles penetrate the skin, dissolve, and deliver drug. The objectives of the proposed Phase I study are two-folds: (1) Study material properties of microneedle materials and determine promising formulations for controlled delivery of sumatriptan (2) Study the dissolvable microneedles and basal layer incorporating sumatriptan for rapid and sustained delivery for 24 hours. The broader/commercial impacts of this research are two fold. First, the project outcome will affect approximately 600 million people worldwide (about 10% of the adult population) and about 28 million in the US who suffer from moderate to severe chronic migraine pain. Second, the proposed dissolvable microneedle technique is generic and once microneedle materials are developed it will be used in a wide variety of drugs. For example, the anticipated market size of protein drugs that benefit from the TheraJect's technology is more than $30 billion, expanding rapidly due to advances in biotechnology and DNA recombinant technology.