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HomeLatest Pharma-NewsMoberg Pharma meets primary endpoint for MOB-015 (topical terbinafine) in a phase...

Moberg Pharma meets primary endpoint for MOB-015 (topical terbinafine) in a phase 3 study for the treatment of Onychomycosis

Dec 9, 2019: Moberg Pharma announces that MOB-015 (topical terbinafine) met the primary endpoint and also key secondary endpoints in the North American Phase 3 study including 365 patients with mild to moderate toenail onychomycosis (nail fungus).

At week 52, considerably more patients reached complete cure for MOB-015 than for vehicle (p=0.019), following 48 weeks of daily treatment.

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The purpose of this randomized, multicenter, controlled clinical Phase 3 study was to evaluate the efficacy and safety of MOB-015 in patients with mild to moderate distal subungual onychomycosis (DSO) affecting 20-60 percent of the great toenail.

The study was conducted at 32 sites in the U.S. and Canada along with 365 patients, 246 patients receiving MOB-015 and 119 patients receiving vehicle.

Patients received treatment during 48 weeks and had the last follow-up assessment at week 52. in general MOB-015 was well tolerated.

cure rate in the study is extraordinarily high for a topical treatment, due to fungicidal activity of terbinafine in MOB-015.


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