Levosimendan Trial – Phase 3
Levosimendan is under development in North America for reduction in morbidity and mortality of cardiac surgery patients at risk of low cardiac output syndrome (LCOS).
The FDA has granted Fast Track status for levosimendan based on the drug’s potential to fill a serious unmet medical need and agreed to our Phase 3 clinical trial protocol under a Special Protocol Assessment (SPA). The FDA provided guidance that a single successful trial will be sufficient to support approval of levosimendan in this indication.
The Phase 3 clinical trial studied if levosimendan administered before and during surgery will reduce the incidence of morbidity and mortality in cardiac surgery patients at risk. There is substantial scientific evidence for the use of levosimendan in cardiovascular surgery, including data from over 30 published clinical trials.
Enrollment in the clinical trial was completed in December 2016. The study did not achieve the designated endpoints in the SPA so further discussions will be held with regulatory authorities in the US and Canada for guidance on what, if any, additional data would be needed to gain market approval for levosimendan. Additional information about the trail can be found at https://clinicaltrials.gov/ct2/show/NCT02025621.