UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
Current Report
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| ITEM 8.01 | OTHER EVENTS |
On August 22, 2019, Retrophin, Inc. announced that the Phase 3 FORT Study evaluating the safety and efficacy of fosmetpantotenate compared to placebo in patients with pantothenate kinase-associated neurodegeneration (PKAN) did not meet its primary endpoint and did not demonstrate a difference between treatment groups. The study also did not meet its secondary endpoint. Fosmetpantotenate was observed to be generally safe and well-tolerated in the study.
The FORT Study was an international, randomized, double-blind, placebo-controlled, Phase 3 clinical trial assessing the safety and efficacy of fosmetpantotenate in 84 patients with PKAN. Patients received either three times-daily dosing of fosmetpantotenate or placebo using a 1:1 randomization over 24 weeks. The primary endpoint in the study was the change from baseline in the PKAN-ADL scale through 24 weeks of treatment.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| RETROPHIN, INC. | ||||||
| Dated: August 22, 2019 |
By: |
/s/ Elizabeth E. Reed | ||||
| Name: |
Elizabeth E. Reed | |||||
| Title: |
Senior Vice President, General Counsel and Secretary | |||||