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Anacor Pharmaceuticals Inc Announces Positive Results From First Of Two Phase 3 Trials Of Tavaborole For Onychomycosis


Tuesday, 29 Jan 2013 07:00am EST 

Anacor Pharmaceuticals Inc announced positive preliminary results from first of two Phase 3 trials of tavaborole, topical anti-fungal for onychomycosis, a fungal infection of nail and nail bed that affects approximately 35 million people in United States. Tavaborole achieved a high degree of statistical significance on all primary and secondary endpoints. In this first Phase 3 study (known as Study 301), 6.5% of patients treated with tavaborole met primary endpoint of complete cure vs. 0.5% of patients treated with vehicle (p=0.001) at week 52. Complete cure is a composite endpoint that requires both a mycological cure and a completely clear nail. Study 301 enrolled 594 patients in United States and Mexico with distal subungual onychomycosis, randomized two-to-one to receive either tavaborole, 5% solution, or vehicle. Eligible patients were at least 18 years of age (with no upper age limit) with a clinical diagnosis of distal subungual onychomycosis involving 20% - 60% of the total area of target great toenail, at least 3mm of clear nail from proximal nail fold to the proximal visible mycotic border and positive mycology. Patients were instructed to apply tavaborole solution or vehicle to the target great toenail once daily for 48 weeks. Overall, tavaborole was safe and well-tolerated across study subjects. There were no serious adverse events related to study drug. The rate of discontinuations as a result of adverse events was low (2.8% for tavaborole and 1.6% for vehicle). 

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32.425
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