Flexion Therapeutics Inc. (NASDAQ: FLXN) has announced that the U.S. Food and Drug Administration (FDA) informed the company that it needs additional time to complete the review of the supplemental New Drug Application (sNDA) for Zilretta.
Note that the anticipated Prescription Drug User Fee Act (PDUFA) action date was today, October 14, 2019.
Although the FDA did not provide a new action date, the FDA informed the company that the review is expected to be completed in the coming weeks. The FDA has not asked for any additional clinical data, and the company has provided the FDA with all information requested to date.
In December 2018, the company filed the sNDA seeking to revise the Zilretta product label based on results from an open-label Phase 3b clinical trial, which evaluated repeat administration of Zilretta in patients with osteoarthritis knee pain.
The approval of Zilretta was based on the pivotal Phase 3 trial that demonstrated that this steroid significantly reduced knee pain for 12 weeks, with some people experiencing pain relief through week 16.
Shares of Flexion traded down about 5% in Monday’s premarket but were last seen up fractionally at $13.46, in a 52-week range of $8.76 to $19.82. The consensus price target is $25.78.