BUPI - a long-acting lozenge with bupivacaine for pain relief of Oral Mucositis in cancer patients
| Reference number | |
| Coordinator | PCG CLINICAL SERVICES AB |
| Funding from Vinnova | SEK 12 000 |
| Project duration | October 2015 - September 2018 |
| Status | Completed |
| Venture | Eurostars |
| Call | Eurostars medfinansiering 2014-2015 |
Purpose and goal
Moberg Pharma and partners will further develop and commersialise BUPI (bupivacaine) - an innovative and superior long-acting treatment for cancer patients suffering from pain associated w ith Oral Mucositis (OM). BUPI will be evaluated in a phase III trial. The Project will deliver a final product ready for registration and thereafter launch with documented benefits for the patients.
Expected effects and result
The aim of the project is to deliver a patented bupivacaine lozenge (Bupizenge) ready for registration and for launch in the EU. The product should also have received ´Orphan Drug´ status in the EU and USA.
Planned approach and implementation
The project is divided into five Work-Packages (WP). WP 1 - R&D and manufacturing (development of new taste, manufacturing for the phase III study including stability study and documentation). WP 2 - Phase III study in collaboration with partners (CRO and hospitals in Sweden and Denmark). WP 3 - Market access preparations for sales under Named Patient Basis and Orphans Drug application in USA. WP 4 - Protection of product results and publishing/communication of results from clinical trials. WP 5 - Project management and co-ordination of project activities.