Bernadetta Bailey was diagnosed with multiple sclerosis in 1981, when she was 20, and she has battled fatigue and muscle weakness ever since. She says her emotional problems began to appear in her 30s.
"There was no rhyme or reason" to her outbursts, she says. She could do something as simple as look at a light switch and burst into tears.
"It wasn't grief that overcame me but this emotion where I just started sobbing and sobbing and sobbing and couldn't quit," Bailey says, adding that she would also laugh inappropriately at funerals, or when someone got hurt.
The scientific name for the condition is pseudobulbar affect, or PBA. It's also known as emotional incontinence.
The Food and Drug Administration has approved the first drug that could help people like Bailey who suffer from PBA.
Alone And Emotional
PBA is caused when disease or injury creates a malfunction in the brain circuits involved in expressing emotion. It affects some people who have multiple sclerosis, ALS (Lou Gehrig's disease), Alzheimer's or Parkinson's. It also can strike people who have had a stroke, or a traumatic brain injury -- including the sort that has become common among troops in Iraq and Afghanistan.
Bailey says whatever the cause, the outbursts are disruptive and embarrassing. "I just some days want to crawl in a hole," she says. "It makes other people uncomfortable because they think they should try and help me where there's nothing they can do."
So Bailey watched her kids compete in high school athletic events from inside her car. These days she spends a lot of time mountain biking or kayaking -- by herself.
But Bailey says there was a brief period a couple of years ago when her PBA got much better. That's when her doctor enrolled her in a study of the drug that would become known as Nuedexta.
She remembers asking her doctor if he could tell her whether she'd be getting the drug or a placebo.
"He said, 'No, but you'll know it within a couple hours,' " Bailey says. "So I went in, they gave me a capsule, and an hour later, by the time I got home, I knew I was on the drug cause I wasn't crying all the time."
Discovered By Accident
Results submitted to the FDA showed that Nuedexta reduced episodes of PBA by about half.
That's quite a feat for a drug that was discovered by accident, says Erik Pioro, director of the section of ALS and related disorders at the Cleveland Clinic. Pioro also took part in the FDA trial of Nuedexta.
The active component of the product is dextromethorphan, which has been used for years in cough syrup, Pioro says. Researchers once hoped dextromethorphan could actually slow the progress of ALS. It didn't, he says. But some patients who got it noticed they were having fewer emotional outbursts.
By some estimates, about 2 million people in the U.S. suffer from PBA. But it's hard to get a precise figure because it's not something people like to talk about, Pioro says.
"Very often patients are too embarrassed to even bring up the possibility that they have something like that going on,” he says.
New Formulation
It has taken a dozen years to bring Nuedexta to market. One reason is that the product combines dextromethorphan with a drug called quinidine, which keeps the active ingredient in the bloodstream longer.
But quinidine can affect heart rhythms and has other side effects. So in 2006, the FDA asked Avanir, the small company developing Nuedexta, to study a formulation that used less quinidine.
By then, "we had very small amounts of cash," says Keith Katkin, Avanir's president and CEO. "But were able to find investors who were willing to take a bet and help us develop the first approved treatment for PBA."
Katkin says Nuedexta should begin reaching patients early in 2011 and that it's likely to cost $3,000 to $5,000 a year.
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