A new drug application (NDA) to the US Food and Drug Administration  (USFDA) for its lead investigational product- triamcinolone acetonide was submitted, which is being assessed to treat patients with osteoarthritis (OA) of the knee. Triamcinolone acetonide has accomplished Fast Track designation from the FDA, a designation granted to drugs delibrately to treat serious conditions with the potential to provide significant improvement over existing therapies. From this submission, FDA has up to 74 days to inform the concerning company if the submission has been deemed complete and permits a full review as the triamcinolone acetonide NDA is being submitted as a 505(b)(2) application.

The submission of first NDA is a major milestone in the field of osteoarthritis management. Based on pivotal data, it is believed that triamcinolone acetonide has the potential to be the first intra-articular, extended-release treatment for the many millions of patients who suffer from knee OA. 

The previous reported outcomes from a pivotal Phase 3 clinical trial assists the triamcinolone acetonide NDA for OA of the knee. Worldwide, 484 patients were enrolled at 37 centers in the randomized, double blind, placebo and active-comparator (immediate-release triamcinolone acetonide (TA) controlled trial. According to the data from the trial, triamcinolone acetonide depicted a highly significant (P<0.0001) reduction in average daily pain versus placebo at week 12 (primary endpoint), with durable and clinically meaningful pain relief in patients with moderate to severe OA knee pain. Also, compared to immediate-release TA, the most commonly injected intra-articular corticosteroid, triamcinolone acetonide achieved statistical significance through 12 weeks on WOMAC A1 (pain), WOMAC B (stiffness) and WOMAC C (function). The frequency of treatment-related side effects was comparable across all treatment arms in the trial.

The commonly observed adverse events for triamcinolone acetonide with an incidence greater than 2% were arthralgia, headache, joint swelling and back pain. Due to treatment-related side effect, no drug-related serious adverse events were observed and no patients treated with triamcinolone acetonide were discontinued from the study.