THE ONYCHOMYCOSIS PROBLEM
35 million Americans suffer from onychomycosis and the few prescription antifungals approved by the FDA to date have drawbacks. Oral medications are associated with systemic side effects and the topical agents are plagued by low cure rates. Both approaches require daily dosing for long periods of time, which can be a significant burden to patients.
THE HALLUX SOLUTION
Hallux Inc. is investigating Hallux Subungual Gel (HSG), a new terbinafine topical product and treatment approach for onychomycosis involving periodic subungual (under the nail) applications by a physician enabling new healthy nail to grow out clear of infection.
CLINICAL TRIAL INFORMATION
An open label study to evaluate HSG’s efficacy, safety, tolerability, and pharmacokinetics is under way in patients with distal lateral subungual onychomycosis (DLSO) of the toe.