As announced in a press release dated November 7, 2017, a previous U.S Phase III study did not meet its primary endpoint – change in worst leg pain at week thirteen (13) – and found no statistically significant improvement when compared to a control group, despite demonstrating the expected pharmacologic effect.
In response to this result, Seikagaku has communicated with the U.S. Food and Drug Administration (FDA) and its licensing partner, Ferring Pharmaceuticals, its intention to conduct an additional study. Building on lessons learned from the previous U.S. Phase III study, Seikagaku anticipates a successful outcome for the new trial.
Seikagaku is committed to provide healthy and better quality of life by offering a new treatment option for the patients with lumber disc herniation with approval for SI-6603 in Japan and the U.S.
The start of enrollment for the additional study is scheduled for the second quarter of 2018, and there is no change to the forecast of consolidated financial results for the fiscal year ending March 31, 2018 because of this matter.