today announced that data on the prevalence of symptoms for pseudobulbar
affect (PBA), a distressing condition characterized by sudden and uncontrollable outbursts of laughing and/or crying resulting from certain neurologic diseases or brain injury (TBI), and the use of antipsychotic medications in nursing home residents, were recently published in the International Journal of Geriatric Psychiatry.
The acquisition integrates the buyer's psychiatric products, led by the anti-psychotic AbilifyA (aripiprazole), with Avanir's marketed Nuedexta, a mix of dextromethorphan and quinidine that is FDA's first approved treatment indicated for Pseudobulbar
Affect (PBA), and several Avanir drug candidates.
ORLANDO -- The prevalence of pseudobulbar
affect symptoms--that is, uncontrollable, disruptive outbursts of crying and/or laughing--is considerably greater across a range of neurologic disorders than previously appreciated, according to the largest-ever study to screen for this condition.
The involuntary giggling is known as pseudobulbar
affect and is thought to be caused by disruptions to nerves during surgery.
Enna's constant giggling is called the Pseudobulbar
effect - where patients who have had brain tumour surgery often express involuntary emotions.
A combination of dextromethorphan hydrobromide and quinidine sulfate recently became the first treatment to be approved by the Food and Drug Administration for the treatment of pseudobulbar
affect, based on a study of patients with amyotrophic lateral sclerosis and multiple sclerosis.
The medicine, Nuedexta, is the first approved to treat patients with multiple sclerosis or Lou Gehrig's disease who develop symptoms known as pseudobulbar
affect that causes loss of emotional control, the FDA said.
AVANIR is currently in the process of submitting to the FDA a "rolling" new drug application for Neurodex for the treatment of pseudobulbar
affect and expects to complete the submission by June 30, 2005.
Neurologic disorders such as Arnold-Chiari malformation, myotonic dystrophy, pseudobulbar
palsy, pharyngeal paresis, myasthenia gravis, and neurofibromatosis
Thousands of patients have benefited from NUEDEXTA since its launch in 2011 and this decision gives us the opportunity to continue helping those suffering from pseudobulbar
affect (PBA) for many years to come," said Keith A.
A biopharmaceutical firm specializing in central nervous system (CNS) diseases, Avanir is the manufacturer of Nuedexta, the only FDA-approved treatment for the neurological disease pseudobulbar
Patients were given a test measuring how often they laughed or cried unintentionally due to a neural disorder known as pseudobulbar