It is laughter devoid of inner joy, and weeping without sorrow.
Involuntary outbursts of laughing and crying not tied to underlying emotion can afflict people with neurological ailments like multiple sclerosis, Lou Gehrig’s disease, traumatic brain injury and stroke.
Now there is a drug for it. On Oct. 29, the Food and Drug Administration approved the first medicine to treat the condition, which is called pseudobulbar affect.
The drug, called Nuedexta, was developed by Avanir Pharmaceuticals of Aliso Viejo, Calif.
Keith Katkin, chief executive of Avanir, said the company estimates that two million Americans suffer from the condition.
“We like to refer to PBA as one of the most common diseases that people have never heard of,’’ he said in an interview earlier this week.
Estimates are somewhat imprecise, however. Only five years ago the company was estimating that there were fewer than a million people with the condition.
The company faces a marketing challenge. Many patients and doctors do not know the condition exists. And there is skepticism that PBA warrants treatment, given that people with the condition have more serious underlying diseases.
Mr. Katkin said that laughing and crying at inappropriate times can be socially debilitating. He cited the case of a grandmother who was not allowed to stay with her young grandchildren because she would suddenly burst into tears and scare them.
The difficult and unusual name of the condition is also a barrier to marketing the drug, especially since the “pseudo’’ makes it sound like a fake ailment. The company at one point tried to coin its own name – involuntary emotional expression disorder — but the drug administration nixed that.
Nuedexta is a combination of two existing drugs. One is dextromethorphan, an ingredient in some cough medicines. The other is quinidine, a drug used to treat malaria and heart arrhythmia.
It is believed that dextromethorphan binds to certain receptors in the brain to dampen the laughing and crying. The quinidine keeps the dextromethorphan from breaking down quickly.
The F.D.A. turned down the drug in 2006, citing concerns that the quinidine could cause heart rhythm problems. Avanir did a new clinical trial using only one third of the previous dose of quinidine.
The trial involved 326 patients with either multiple sclerosis or Lou Gehrig’s disease, known formally as amyotrophic lateral sclerosis.
Before entering the trial, the patients had 4 to 6 episodes of laughing or crying a day, with each usually lasting from 30 seconds to more than five minutes.
At the end of 12 weeks the number of incidents for those getting the high dose of the Neudexta had fallen by about 88 percent, to only about 0.6 per day. That was a significantly greater reduction than for those getting the placebo.
Neudexta will go on sale in the first quarter. While the price hasn’t been announced, Mr. Katkin said it would probably be between $3,000 and $5,000 a year. Analysts estimate sales could eventually reach a few hundred million dollars a year.
Wednesday, November 3, 2010
From The NY Times:
Posted by BA Haller at 3:15 PM