FDA Approved sNDA to Update Label for Flexion Zilretta

| By | FDA, New Drug Application

Flexion Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) to update the product label for ZILRETTA (triamcinolone acetonide extended-release injectable suspension) for the treatment of osteoarthritis (OA) knee pain.

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.

“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,”

said Michael Clayman, M.D., President and Chief Executive Officer of Flexion.

“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.”

Added John Richmond, M.D., Medical Director for Network Development, New England Baptist Hospital,

“As both a clinician and a ZILRETTA patient, I have firsthand experience with the significant magnitude and duration of pain relief it can provide to people confronting knee OA. ZILRETTA is an invaluable non-opioid option for managing chronic OA knee pain, and it is encouraging to see a new product label that better informs clinical decision making.”