TIB200 is a topical 10% ibuprofen gel for pain relief that utilises Futura's DermaSys® technology. DermaSys® enables ibuprofen to be delivered rapidly and efficiently through the skin. Local application and rapid, efficient absorption translate into a fast onset of action, and the potential for twice-daily dosing.
Application of gel with ibuprofen
Combination of solvents, including volatile solvents.
Volatile solvents evaporate, leaving the remaining solvent supersaturated with ibuprofen.
Supersaturation drives ibuprofen rapidly through the skin.
Ibuprofen penetrates the skin rapidly to reach the site of action.
In early in vitro studies and in an in vivo clinical study DermaSys® showed significant superiority in terms of skin penetration of ibuprofen. TIB200, a topical gel combining the well-known analgesic ibuprofen with the DermaSys® delivery system, has been shown to achieve superior penetration through human skin compared with other commercially available topical ibuprofen gels.
In a proof of concept study in a model of UV-induced erythema and pain, the efficacy and safety of TIB200 was assessed against a market-leading ibuprofen gel, oral ibuprofen, as well as a placebo gel. TIB200 outperformed both topical and oral comparators, and placebo.
TIB200 has attracted considerable interest from pharmaceutical and consumer healthcare companies. We continue to be in discussions regarding potential regional licensing deals. EU regulators require a placebo controlled efficacy study prior to EU regulatory filing. Futura made the strategic decision to require partner commitment before progressing this clinical expenditure.