Essentialis announced that the FDA has granted orphan drug designation to diazoxide choline, the active ingredient in DCCR for the treatment of Prader-Willi syndrome.
DCCR is a proprietary crystalline salt of diazoxide in a controlled-release, once-daily tablet formulation. It is being investigated for the treatment of Prader-Willi syndrome, a rare neurobehavioral/metabolic disease, and hypothalamic obesity.
Orphan drug designation allows Essentialis to a 7-year period of marketing exclusivity in the United States for DCCR if it is approved by the FDA for the treatment of Prader-Willi syndrome.
For more information call (760) 444-0446 or visit Essentialistherapeutics.com.