Aerial BioPharma announced that the FDA has granted orphan designation for ARL-N05 for the treatment of narcolepsy.

The news from the FDA follows the successful completion of a Phase 2a study where ARL-N05 demonstrated highly statistically significant results on the primary and secondary efficacy endpoints in patients with narcolepsy.

ARL-N05 will begin a Phase 2b clinical trial in September with results expected in mid-2013.

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