Anacor Pharmaceuticals, Inc. (ANAC) recently announced positive preliminary results on tavaborole (AN2690) from Study 302. Tavaborole is being developed for the prevention of onychomycosis.
Study 302 is the second of two phase III clinical trials on tavaborole for onychomycosis. The study was conducted under the US Food and Drug Administration’s (:FDA) Special Protocol Assessment (SPA) program.
The study met both the primary and secondary endpoints. The primary endpoint included the achievement of “complete cure” (9.1% of patients in the tavaborole arm compared to 1.5% in the vehicle-treated arm).
Secondary endpoints included the achievement of a "completely clear" or “almost clear" nail (27.5% of patients in the tavaborole arm compared to 14.6% in the vehicle-treated arm), achievement of mycological cure (35.9% of patients in the tavaborole arm compared to 12.2% in the vehicle-treated arm) and the achievement of "completely clear" or "almost clear" nail with mycological cure (17.9% of patients in the tavaborole arm compared to 3.9% in the vehicle-treated arm).
Anacor will file a new drug application in the US in mid-2013.
We are encouraged by the positive results from the second phase III study of Anacor’s tavaborole. However, we remain concerned about the much more favorable results of Valeant Pharmaceuticals’ (VRX), onychomycosis candidate, efinaconazole.Read the Full Research Report on VRX
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