FDA fast-track/orphan status for Chelsea's droxidopa

The US Food and Drug Administration has granted fast-track designation for US biopharmaceutical company Chelsea Therapeutics' droxidopa for the treatment of symptomatic neurogenic orthostatic hypotension.

In addition, the FDA granted droxidopa orphan drug status for the treatment of this condition and subsequently awarded Chelsea a Special Protocol Assessment 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/or 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.