Orphan Drug Designation for ARL-N05 for Narcolepsy
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.
For more information visit www.aerialbio.com.