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New Drug Approved For Emotional
Incontinence
November 1, 2010 - NPR
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.
Dxm is weird stuff, i really dont like it except for its intended cough suppressant purpose. So its hard for me to imagine that taking it in large amounts on a daily basis would be helpful to anyone, i think id rather be all emotional.
But if they say it helps then whatever. I also wonder how strong it really is, can these people drive after taking their super potent dxm? Maybe its just like a double dose of the normal stuff, and not like when you drink a whole bottle of robo to trip, which is like 10 normal doses.
This is a 20 mg formulation of DXM. Interesting that the press refers to it as "superpotent" after the addition of quinidine.
-------------------- ...the whole experience is (and is as) a profound piece of knowledge. It is an indellible experience; it is forever known. I have known myself in a way I doubt I would have ever occurred except as it did.
Smith, P. Bull. Menninger Clinic (1959) 23:20-27; p. 27.
...most subjects find the experience valuable, some find it frightening, and many say that is it uniquely lovely.
Osmond, H. Annals, NY Acad Science (1957) 66:418-434; p.436
I used the term superpotent to describe it. Nowhere in the article does it say or suggest patients were "taking it in large amounts". The addition of quinidine makes DXM more potent by keeping "the active ingredient in the bloodstream longer" which would require smaller dosages not larger. Yes the medication contains just 20mg DXM which is taken only once daily initially, being less than the dosage taken for coughs.
Which takes us back to sui's point that a patient without 3-5k could take OTC DXM. I would think that they could.