TK-254R

About TK-254R

TK-254R is an investigational s-flurbiprofen 1.5% hydrogel patch for acute minor sport injury with a clean safety profile designed for once daily application for up to seven days. TK-254R uses our proprietary Hydrohesive® technology and is being evaluated for use in acute strains, sprains or contusions to reduce pain symptoms.

TK-254R recently completed a Phase II study with patients presenting acute strains, sprains or contusions. The double-blind, placebo-controlled, multi-dose study evaluated the analgesic efficacy and safety of TK-254R in 200 patients. Preliminary results show clear efficacy with a clean safety profile, and only three mild adverse events reported, which were not drug-related (TK-254R: 2, Placebo: 1). Patients who received TK-254R reported early pain reduction from 12 hours after application and constitutive pain reduction up to 168 hours following application.

Choosing Topical NSAIDs over Oral NSAIDs

Nonsteroidal anti-inflammatory drug (NSAID) patches offer easy topical application that delivers targeted pain relief with less potential gastrointestinal or cardiovascular side effects than oral NSAIDs. The therapeutic effect of topical NSAIDs is designed to be targeted locally to damaged tissue, thus minimizing systemic exposure.[1]

Previous research on rheumatoid arthritis patients showed patients using topical NSAIDs had 36% lower risk for cardiovascular events compared with those using oral NSAIDs.[2]

Previous research also found that, in chronic and acute pain patients, topical NSAIDs are associated with fewer serious adverse gastrointestinal events when compared with oral NSAIDs.[1]

Our proprietary Hydrohesive® technology uses a skin-friendly hydrophilic adhesive formulation with high water content that provides a fresh, cooling effect on the skin. Discontinuation of therapy is immediate upon removal of the patch.

[1] “Effectiveness and Safety of Topical Versus Oral Nonsteroidal Anti-Inflammatory Drugs: A Comprehensive Review,” The Physician and Sports Medicine, 2013, vol. 41, no. 2, pp. 64-74.

[2] “Comparative Risk of Cardiovascular Outcomes Between Topical and Oral Nonselective NSAIDs in Taiwanese Patients With Rheumatoid Arthritis,” Journal of the American Heart Association, 2017, vol. 6, no. 11 (e006874).

RESEARCH & DEVELOPMENT

Uncovering What’s Possible

With deep expertise in dosage form development plus comprehensive manufacturing capabilities, we create both the formulations and the delivery mechanisms that bring innovative ideas to life.