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.

Project Report

The overall objective of the Small Business Innovation Research project is to develop a new sumatriptan delivery patchfor effective migraine therapy. The Phase I aimed to determine the optimal patch materials, design, and fabrication. ???Intellectual Merit: ??Migraine affects approximately 600 million people world wide, and in the US about 28 million suffer from moderate to severe chronic pain. Triptans are the mainstay of treatment for acute migraine. TheraJect has developed a new, revolutionary sumatriptan delivery patch that will provide a less-invasive, rapid release of migraine medication (e.g. sumatriptan) with minimal inconvenience to patients. Broader Impacts: The proposed patch technology for painless drug delivery through the skin is generic and its use is envisioned for a wide variety of drugs . This technology will open up new ways for novel drug delivery methods that will be capable of delivering drug through the skin. The potential impact of the outcome of the proposed patch technology is extremely broad, potentially bringing a migraine pain relief to about 10% of the adult population worldwide that suffer from moderate to severe chronic migraine pain. Research outcomes: (1) optimization of the patch formulation components for manufacturing of the patch with satisfactory mechanical properties (2) optimization of the formulation components with respect to the rapid release of sumatriptan through the skin (3) demonstration of the capability of the patch for sumatriptan skin delivery and (3) development of manufacturing methods of the patch.

National Science Foundation (NSF)
Division of Industrial Innovation and Partnerships (IIP)
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Gregory T. Baxter
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United States
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