The new treatment for curbing these unwanted crying and laughing episodes uses two drugs, dextromethorphan and low-dose quinidine. Early indications are that the two drugs do reduce the incidence and severity of these episodes and improve quality of life.
"There's no FDA-approved therapy for pseudobulbar affect," notes study lead author Erik P. Pioro, M.D., director of the section for ALS and related disorders at the Cleveland Clinic in Ohio, and a member of the American Academy of Neurology (AAN). "The off-label medications that are being used have their own set of side effects and problems. So from a medical and patient care point of view, it would be very worthwhile to have an approved medication that is both safe and effective," he says.
The study results were presented at the recent AAN annual meeting in Toronto.
The study authors note that PBA typically manifests in people with an underlying neurological illness, including those with MS. Dr. Pioro says that conservative estimates put the number of Americans with PBA at close to 2 million, although he said the figure might actually be as high as 6 million to 7 million.
In the study, Dr. Pioro and his colleagues enlisted 283 people with PBA in an initial drug trial, during which some participants received one of two dosage levels of the two medications, while others received placebos.
After a two-week break, this was followed by a second phase involving 253 of the original study participants. During the study's second part, participants were exposed to daily doses of the two-drug regimen for 12 weeks.
Dr. Pioro and his colleagues observed "significant improvement" among all the participants — particularly among those who had not been exposed to the drug combo until the second part of the study.