FDA panel has rejected the FDA approval of Q-Med's Durolane. The efficacy concerns for the product were not satisfied as the study data showed limited benefit compared to placebo. The panel also raised issue about the study design and the data evaluation.
Q-Med has conducted three separate studies on Durolane. The original PMA was submitted in 2006 based on first two studies which enrolled 564 patients between them to compare Durolane to a placebo (saline). The study results were not superior than placebo however, a subgroup post-hoc analysis were. This data was insufficient for FDA to support safety and efficacy.
Based on suggestions, Q-Med made changes to its ongoing third study which compared Durolane to methyl prednisolone acetate (MPA) injection, a corticosteroid and the standard of care. Q-Med limited enrollment to the patients with the same conditions used for the earlier sub-group analysis. The company submitted non-inferiority as the endpoint, but the FDA asked for superiority over MPA. Q-Med kept their original endpoint and succeeded in showing non-inferiority. Moreover, there were concerns over timing. The endpoint of the study was 12 weeks, but the MPA may not have been effective after six weeks, which did not favor Durolane. Q-Med addressed this by conducting a literature review and re-analyzing their data in an attempt to demonstrate that the effects of MPA lasted longer than commonly believed. This attempt was successful in showing superiority of both Durolane and MPA to saline. Q-Med resubmitted in March 2008, the sub-group analyses from studies one and two as well as the non-inferiority data and additional analyses from study three.
Smith & Nephew who was the product distributor and Q-Med reported that they would continue to work with the FDA to fulfill its data needs and remain committed to bringing the product to the US market. Q-med reported that Durolane is already available for Osteoarthritis in 32 countries, including Canada.