Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Northera Ongoing Trial May Satisfy FDA Request For More Efficacy Data, Chelsea Says

This article was originally published in The Pink Sheet Daily

Executive Summary

In a “complete response” letter to Chelsea for use of droxidopa in treating neurogenic orthostatic hypotension, FDA requests data from an additional trial showing efficacy and durability of effect. Chelsea believes ongoing Study 306, which has had its own efficacy challenges, could fill the bill and enable an NDA resubmission as early as the first quarter of 2013.

You may also be interested in...



Chelsea’s Northera Clears FDA But With A Confirmatory Trial Requirement

Northera was approved by FDA under the Subpart H accelerated approval pathway; the Indications and Usage section of the drug’s labeling notes the lack of efficacy data for treatment with the drug beyond two weeks.

Data Limitations Continue To Plague Northera As The NOH Therapy Goes To Its Second Advisory Committee

FDA will ask the Cardiovascular and Renal Drugs Advisory Committee Jan. 14 whether there is a population that showed a better than mean effect for the primary endpoint of dizziness.

Acceptability Of Revised Study Expected To Be On Agenda For Northera Advisory Panel

Chelsea would address duration of effect questions for the neurogenic orthostatic hypotension drug with a post-approval study.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS073949

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel