In addition to fast track designation, the FDA has granted Droxidopa orphan drug status for the treatment of symptomatic neurogenic orthostatic hypotension and subsequently awarded Chelsea a special protocol assessment (SPA) for the second of its pivotal studies in this program.
An SPA provides a binding agreement that the study design, including trial size, clinical endpoints and data analyses is acceptable to support regulatory approval. Orphan drug designation provides seven years of marketing exclusivity from the date of a drug’s approval. In addition, user fees are waived and the sponsor is eligible for tax credits for clinical testing.
Simon Pedder, president and CEO of Chelsea Therapeutics, said: “We remain focused on executing our ongoing Phase III program to facilitate the expeditious filing of a new drug application and obtaining the approvals required to make Droxidopa available to this underserved patient population.”