Flexion Therapeutics Inc (NASDAQ:FLXN) reported the Food and Drug Administration’s approval of sNDA to revise ZILRETTA product label.
The Burlington, Vermont-based Flexion reported Thursday that key elements of the label update include: Removal of language which stated that ZILRETTA was "not intended for repeat administration." The updated label states that the "efficacy and safety of repeat administration of ZILRETTA have not been demonstrated."
Inclusion of a study description and safety data from the single-arm, open-label Phase 3 repeat administration trial.
Removal of a misleading statement describing a single secondary exploratory endpoint in the original Phase 3 pivotal trial which compared ZILRETTA to immediate release triamcinolone acetonide crystalline suspension.
Inclusion of nonclinical toxicology data from previously submitted single and repeat administration studies in non-diseased animals.
Said CEO Michael Clayman, "We are very pleased with the new product label as it achieves our primary goal of removing unclear language pertaining to repeat administration, which we believe was potentially confusing to patients, physicians and payers alike.
"In addition, we are gratified by the inclusion of safety data from our repeat administration trial and the removal of the inappropriate comparator statement. We believe the updated label supports our goal of seeing ZILRETTA become the leading intra-articular therapy for managing OA knee pain."
On October 6, 2017, ZILRETTA was approved by the U.S. FDA as the first and only extended-release intra-articular therapy for patients confronting osteoarthritis-related knee pain.
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