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Topical Ibuprofen (SST-0225) for the Treatment of Mild to Moderate Aches and Pains

Prevalence and Treatment

NSAIDS are used by more than 30 million in the US alone. This is expected to increase as an aging population that is more active and working later in life combine to drive growth in the OTC marketplace. While proven effective in the treatment of pain and inflammation, oral ibuprofen is associated with a number of serious adverse effects, most notably increased risk for heart attack and stroke and gastrointestinal irritation (primarily due to inhibition of COX-1). Current oral preparations are mandated by the FDA to carry a black box warning explaining these risks.

Currently there are no topical ibuprofen products approved for use in the U.S.

SST-0225 – Topical Ibuprofen Cream

SST's Topical Ibuprofen Cream (SST-0225) is targeted to be an improved therapeutic approach for the over-the-counter (OTC) treatment of localized pain. It delivers therapeutic analgesic levels at the site of the inflamed tissue while keeping systemic plasma concentrations of ibuprofen extremely low, reducing and potentially eliminating the number of side effects commonly associated with the oral form.

Completed phase 1 pharmacokinetic (PK) and safety trials with SST-0225 clearly demonstrate proof-of-principle of the KNOSIS technology. The table below presents the PK data following a single application of 8.7 mL of SST-0225 in normal healthy volunteers, demonstrating successful delivery of ibuprofen across the stratum corneum and into the systemic circulation. No significant systemic or dermal adverse effects were seen with any of the SST-0225 treatment groups.

Development Status and Partnering Opportunities

SST-0225 is currently in Phase 3 clinical trials and is partnered in the U.S. and Canada.