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Nov. 2, 2010 -- The FDA has approved a drug that curbs involuntary and uncontrolled crying and laughing episodes that are experienced by patients with some neurological disorders.
The medication, Nuedexta, is the first to be approved for treatment of people with symptoms known as pseudobulbar affect, or the loss of emotional control.
Other conditions in which this occurs include multiple sclerosis or Lou Gehrig’s disease, technically called amyotrophic lateral sclerosis or ALS.
But the FDA says in a news release that Nuedexta has not been shown to be safe and effective in people with other diseases that can be associated with episodic emotional outbursts, such as Alzheimer’s and other forms of dementia.
Nuedextra is expected to be on the market by prescription in the first three months of 2011.
The medication is a combination of the generic drug quinidine, which prevents heart arrhythmia, and the cough suppressant dextromethorphan.
Avanir Pharmaceuticals, based in Aliso Viejo, Calif., says in a news release that the combination is thought to affect the neurotransmitter glutamate.
The company presented results of a study on the drug at the American Academy of Neurology’s annual meeting in Toronto in April. It showed the patients on the drug reported fewer episodes of involuntary crying and laughing.
In 2006, the FDA decided not to approve the medication because of safety concerns with quinidine causing increased risk of heart rhythm abnormalities. Avanir then reformulated the drug with a lower dose of quinidine.
Avanir said in a news release that pseudobulbar affect occurs secondary to a variety of neurological conditions, and that it is characterized by involuntary, sudden, and frequent episodes of laughing or crying.
Nicholas LaRocca, a vice president of Healthcare Delivery and Policy Research at the National MS Society, says in the Avanir news release that Nuedexta’s approval by the FDA “represents a significant step forward for people who live with the debilitating effects” of pseudobulbar affect and “has the potential to substantially help both them and their families.”
Erik P. Pioro, MD, PhD, FRCPC, director of the Section for ALS and Related Disorders at the Cleveland Clinic, says in the company’s news release that pseudobulbar affect is “a disabling neurologic condition found in patients with underlying neurologic diseases or injuries” that often causes embarrassment “due to their unpredictable emotional outbursts, leading to disruption of their interpersonal relationships and social isolation.”
The study showed that laughing and crying episodes were “significantly reduced” in people taking Nuedexta, compared to patients taking placebo.
Side effects include possible changes in heart rhythm, diarrhea, dizziness, cough, vomiting, weakness, swelling of feet and ankles, urinary tract infection, flu, elevated liver enzymes, and flatulence.
The company says patients should take Nuedexta “exactly as prescribed.”