The Pathway to Prevention (P2P) for ME/CFS: A Dangerous Process
Gabby Klein gives an overview of the P2P process, shedding light on the pitfalls with advice as to what we can do in protest ...
Discuss the article on the Forums.

FDA OKs Northera for Hypotension

Discussion in 'General ME/CFS News' started by Ema, Feb 19, 2014.

  1. Ema

    Ema Senior Member

    Messages:
    3,641
    Likes:
    4,437
    Midwest USA
    The FDA has approved droxidopa (Northera) for the treatment of neurogenic orthostatic hypotension, a rare disease that results in a drop in blood pressure when patients try to stand up.

    The drug was passed up for approval 2 years ago when the FDA asked for more data from an additional clinical trial.

    Approval stems from two clinical trials, each 2 weeks long, in which patients on droxidopa reported less dizziness, lightheadedness, feeling faint, or feeling as if they might black out than those on placebo.

    The FDA noted, however, that the drug was OK'd under its accelerated approval program, which allows it to go on-market for demonstrating an effect on an "intermediate clinical measure" -- in this case, short-term relief of dizziness.

    http://www.medpagetoday.com/Endocrinology/GeneralEndocrinology/44374
     
    Valentijn likes this.

See more popular forum discussions.

Share This Page