Pooled analysis of data from three phase II/III randomized clinical trials on the use of rescue medications with Zilretta

Flexion Therapeutics, Inc. announced that a pooled analysis of data from three Phase II/III randomized clinical trials on the use of rescue medications with Zilretta (triamcinolone acetonide extended-release injectable suspension) were published in Pain and Therapy . The analysis indicated that rescue medication use was significantly lower following a single injection of Zilretta, the first and only extended-release intra-articular therapy for OA knee pain, in comparison to placebo and TAcs.

In clinical trials that evaluate the efficacy of pain therapies, rescue medications, such as acetaminophen, may generally be used by patients to manage acute episodic pain when the primary treatment is not providing sufficient relief. Measuring rescue medication use can provide important information on the robustness of the overall analgesic effect, as effective pain medications should reduce the need for rescue medications and lower the cumulative exposure to potentially harmful side effects.

“The fact that Zilretta reduced patients’ use of acetaminophen speaks to the magnitude of analgesia that Zilretta can provide, and its potential to also limit the need for rescue medications, including addictive options, like opioids,” said Alan Kivitz, MD, Altoona Center for Clinical Research.

Key topline results from the Phase II/III studies: The overall number of rescue medication tablets used per day through Week 24 was significantly less for Zilretta compared to saline-placebo (LSM difference, ?0.43) and TAcs (–0.24); and the safety profile of Zilretta in this pooled analysis was consistent with that of the pivotal Phase III trial.

See- Pain and Therapy pp 1–10 | Cite as Rescue Analgesic Medication Use by Patients Treated with Triamcinolone Acetonide Extended-Release for Knee Osteoarthritis Pain: Pooled Analysis of Three Phase 2/3 Randomized Clinical Trials.-lan J. Kivitz Email author Philip G. ConaghanAmy CinarJoelle LufkinScott D. Kelley. DOI https://doi.org/10.1007/s40122-019-0125-1.