Nuedexta to treat PBA

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FDA Approves Nuedexta to treat Pseudobulbar Affect (PBA)

On October 29, 2010,Avanir Pharmaceuticals, Inc. announced the approval of Nuedexta™ by the Food and Drug Administration (FDA) for the treatment of pseudobulbar affect (PBA) associated with certain neurological conditions, including MS. PBA is characterized by uncontrolled, inappropriate, and/or exaggerated episodes of crying, laughing, or other emotional display. PBA occurs involuntarily with little or no stimulation to invoke such a response. It can greatly impact social situations and overall quality of life, both for the patient and his or her family.

Nuedexta is an oral drug in capsule form. Initially, a patient is given one capsule daily for the first seven days. Beginning on the eighth day, the medication is increased to the full dose of two capsules daily (one capsule every 12 hours). No one should take more than two capsules within a 24-hour period, and if a dose is missed, it will need to be skipped, as two doses should never be taken at the same time.

In studies with Nuedexta, episodes of excessive crying and laughing were significantly reduced in the treated group as compared to placebo, both in terms of frequency and severity. According to Avanir, the response to this drug is readily observable within a short time – often within the first week. In the most recent clinical trial (the STAR trial), about half of the patients with PBA experienced a complete remission of thissymptom by the end of the study while taking Nuedexta. Scores on a scale measuring emotional lability (the Center for Neurologic Study-Lability Scale [CNS-LS]) significantly decreased. The approval of Nuedexta comes after 10 years of research and development.

From: MSAA Motivator Winter/Summer 2011