SBIR-STTR Award

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

This Small Business Innovation Research (SBIR) Phase II project aims to develop a new sumatriptan delivery method for effective migraine therapy that offers both rapid and sustained relief from pain. Triptans are the mainstay of treatment for acute migraine. Migraines are typically treated using tablets or nasal sprays that provide a slow drug release or via injection that provides the fastest drug release. However, the administration via injection is not accessible to patients at the moment of need. The proposed patent-protected drug delivery patch will target over nine million chronic migraine patients who are dissatisfied with currently available pain relief treatment options. The technology is based on the use of dissolvable microneedles that do not cause pain because of their small size. The method will provide a non-invasive, rapid release of migraine medication (e.g. sumatriptan) with minimal inconvenience to patients. It also incorporates a sustained mechanism of drug delivery. The Phase II project objectives are to further optimize the formulations for fabrication of the dissolvable microneedles, scale-up the manufacturing and validate the patch application in animal tests. The broader impact/commercial potential of this project is as follows: The proposed dissolvable microneedle technology for painless drug delivery through the skin is generic and its use is envisioned for a wide variety of drugs. The microneedle technology will enable new ways for novel drug delivery for both small and large drug molecules through the skin. The total potential market size for this platform technology may include protein drugs ($27 billion, expanding rapidly due to advances in biotechnology and DNA recombinant technology), vaccine ($7 billion), and cosmetics ($8 billion). The delivery of migraine medication that is being developed under this project has a $5.0 billion market worldwide because there is an immediate customer need for non-invasive, immediate release pain-relief methods. The potential impact of the proposed technology is very broad, bringing migraine pain relief to about 10% of the adult population worldwide that suffer from moderate to severe chronic migraine pain.