Periodic Reporting for period 2 - RAPID (RAPID MIGRAINE RELIEF WITH ALGINATE-BASED THIN FILM)
Reporting period: 2019-11-01 to 2020-10-31
The RAPID project aims to improve the lives of migraine patients. We know that migraine patients suffer not only from common acute co-morbities such as anxiety and depression, but also longer-term elevated risk of certain neurodegenerative diseases if their migraine attacks are not effectively managed. The RAPID project aims to develop a rapid-acting migraine treatment that also gives the migraine patient confidence in a consistent effect every time they use it. This confidence, in turn, will not only lower the risk of developing anxiety in relation to whether their treatment will work or not, but also allow them to return to their normal lives more quickly after a migraine attack. An additional benefit of the RAPID project is that the resulting product is very compact, easily fitting into a wallet or mobile phone case, so that a patient will always have their medication with them. This results in an earlier intervention in their migraine attack - a key factor in effective acute and chronic migraine management.
The overall objectives of the project are to manufacture and test the final product and assemble a registration package suitable for submission to regulatory authorities for marketing authorization in the EU and US.
The overall objectives of the project are to manufacture and test the final product and assemble a registration package suitable for submission to regulatory authorities for marketing authorization in the EU and US.
The RAPID project has established a robust and realistic clinical trial design and assembled all of the documentation necessary for ethical approval of the pivotal clinical trial. In addition, the manufacturing site and contract has been established and several small-scale feasibility trial have been performed in preparation for the final full-scale manufacturing. In addition, the project has now submitted patent applications in all relevant markets, including the EU and US in order to ensure commercial success of the final product.
The RAPID project has one goal: To register a migraine treatment that will help patients intervene in their migraine attack earlier and more reliably than previously possible. Early and reliable intervention is key to both acute and chronic health of patients and to their overall quality of life.