March 7, 2014

FDA Approves Drug Northera to Treat Blood Pressure Crashes Upon Standing

On February 18, 2014, we learned that the Food and Drug Administration had approved the drug droxidopa (brand name Northera) to treat neurogenic orthostatic hypotension (NOH) – a sudden drop in blood pressure when standing up. That problem plagues many people with Parkinson’s, and is dangerous because it can cause light-headedness, dizziness, falls, and injury.

The drug’s manufacturer – Chelsea Therapeutics in North Carolina -- reported that the drug should become available in the second half of this year.

Although droxidopa has been used to treat NOH in Japan since 1989, its path toward approval in the U.S. has been trickier. As recently as March, 2012, the FDA denied approval of the drug, questioning its efficacy after a week of use. People taking a placebo had results that appeared to be statistically no different from study subjects taking Northera.

The FDA: “More Data, Please”
Nonetheless -- particularly since no other effective treatment exists for NOH -- the FDA left the door open, challenging Chelsea Therapeutics to produce additional efficacy data from an ongoing clinical trial. And this time, the agency gave Northera the green light.

Explained Norman Stockbridge, director of the Division of Cardiovascular and Renal Drugs in the FDA’s Center for Drug Evaluation and Research:
People with neurogenic orthostatic hypotension are often severely limited in their ability to perform routine daily activities that require walking or standing. There are limited treatment options for people with NOH and we are committed to helping make safe and effective treatments available.

According to Chelsea, the approval will interest about 300,000 people in the U.S. and Europe who experience NOH, often as a function of illnesses like Parkinson’s. Northera works when the body converts the drug into norepinephrine, which in turn increases blood pressure.

Warning on the Box
As we see all the time, there are risks. In Northera’s case, patients are warned that the drug may increase blood pressure while they’re lying down (supine hypertension), a condition that can lead to stroke. The FDA recommends that people who use the drug sleep with their upper bodies elevated.

Needless to say, the approval sent a jolt through Chelsea Therapeutics. On February 19 – the day after Northera’s approval was announced – the company’s stock price increased 30%. And there may be even more good news for the product ahead.

Another Bonanza?
The Michael J. Fox Foundation has funded a separate Phase II study into droxidopa’s potential for treating cognitive impairment in people with Parkinson’s. Here’s how the Foundation described the project in its grant abstract:
Forty PD patients with mild cognitive deficits will receive droxidopa (a synthetic amino acid that can be converted in the brain to norepinephrine) or a placebo. Each patient will be switched for six-week trials of each regimen. Participants will undergo neuropsychological testing that emphasizes memory, reasoning ability, speed of solving problems and other similar tasks. The neuropsychological testing chosen for this clinical trial corresponds to circuitry of the brain where norepinephrine is actively involved.

As of today, the MJFF is still actively recruiting research study participants. If you’re interested, click here.

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Many media outlets picked up the story of Northera's FDA approval. Here are just a few:



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