Northera Approved by FDA

jbeck.jpgNearly two years ago, I wrote about how the US Food and Drug Administration (FDA) appeared to be ready to approve a new drug for neurogenic orthostatic hypotension (NOH), which, basically, is a precipitous drop in blood pressure upon standing. (I recommend reading that blog as a good primer.) That drug, droxidopa with the brand name of Northera™, did not win approval because of outstanding concerns by FDA.

Fast-forward to this week, and FDA has now signaled that it will approve droxidopa for the treatment of NOH.

However, FDA approval did not come lightly and several issues remain surrounding the use of droxidopa. Foremost is the fact that droxidopa now carries a black box warning to physicians indicating that the use of this drug carries an increased risk of supine hypotension. This is where one’s blood pressure does not drop as it is supposed to when lying down and, as a result, can lead to stroke.

The other issue for droxidopa remains its long-term effectiveness. Clinical trials have only demonstrated it to be effective for up to two weeks, even in people with Parkinson’s. (The durability or long term effectiveness of droxidopa is being more closely examined in another clinical trial.) Unfortunately, for the people who suffer from NOH, this is a lifetime issue. Nevertheless, there are very few treatment options for NOH and, under the accelerated approval program, FDA recognized this issue in their approval.

Also as part of this accelerated approval, FDA is requiring the drug’s manufacturer, Chelsea Therapeutics, to conduct another clinical trial, called a Phase IV or post-marketing trial, to confirm the results that led to early approval. This will be a large clinical trial (nearly 1,400 participants) and Chelsea will be given up to six years to complete it. (The enrollment period of the trial is so long because so few people have NOH – it is an orphan disease – which in turns means that recruiting that many people can be difficult.) If this trial fails to show a lasting clinical benefit, then FDA reserves the right to pull the drug or modify how it can be used by changing its label.

Let us hope for all the people living with NOH, this trial will be successful.

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