US biopharmaceutical firm Chelsea Therapeutics says that its developmental orthostatic hypotension treatment droxidopa has been accepted for review by the Food and Drug Administration. The drug, which is an orally-active norepinephrine precursor, is currently marketed in Japan and was granted Orphan Medicinal Product designation by European regulators earlier in the year (Marketletter August 20).
Chelsea said that it is seeking US approval to use droxidopa to treat neurogenic orthostatic hypotension, and plans to initiate large scale Phase III trials of the drug in that indication at sites in the USA and Europe over the next few months. The firm added that, if the study program is successful, it plans to submit a New Drug Application to the FDA early in 2009.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Copyright © The Pharma Letter 2025 | Headless Content Management with Blaze