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.
Intellectual Merit Migraine affects approximately 600 million people worldwide, and in the US about 28 millions suffer from moderate to severe chronic pain. The technology is based on using a microneedle skin patch that do not cause pain because of their small microneedle size. The method will provide a less-invasive, rapid release of migraine drug (sumatriptan) with minimal inconvenience to patients. The Phase II project demonstrated the feasibility of the advantages in rats and rabbits. Broader Impacts The microneedle technology for painless drug delivery through the skin is generic and its use is envisioned for a wide variey of drugs. The Phase II project demosntrated a small molecule drug (sumatriptan) delivery in rats. The technology will open up new ways for novel drug delivery methods that will be able of delivering large drug molecules (i.e., peptide and protein) through the skin. Phase II Project Outcomes 1. The project technology can deliver a clinical dose 6mg sumatriptan to the rat systemic blood vessles, suggesting that test continues in human to demonstrate delivery repeatability. 2. A continuous sheet roll process for patch fabrication is feasible, enabling a larg scale patch manufacturing. 3. The sumatriptan microneedles produced a mild, transient skin reaction in a dermal irritation study conducted in rabbits.
