Nuedexta (dextromethorphan hydrobromide and quinidine sulfate) has been approved in capsule form by the Food and Drug Administration (FDA) as the first line of treatment for uncontrolled laughing or crying, medically known as pseudobulbar affect (PBA), Avanir Pharmaceuticals Inc. announced. People with Pseudobulbar Affect may become too emotional for no apparent reason; it is a neurologic condition in which the patient experiences involuntary, sudden and frequent episodes of crying or laughing. Patients with MS (multiple sclerosis), ALS (amyotrophic lateral sclerosis), traumatic brain injuries, stroke, as well as some other neurologic conditions can be affected with PBA. PBA episodes often occur out of proportion to the individual’s underlying emotional state.
Nuedexta acts on sigma-1 and NMDA brain receptors. Exactly what mechanisms occur to reduce episodes of uncontrolled laughing or crying are not clear, experts explain. Clinical trials were carried out on participants with MS and ALS. Nuedexta safety and effectiveness for patients with Alzheimer’s disease and other dementias have not been demonstrated.
Trials showed that patients on Nuedexta had considerably fewer crying or laughing episodes compared to those on a placebo.
Keith Katkin, president and CEO of Avanir said:
The FDA approval of Nuedexta marks an important milestone for people living with PBA, an under-recognized and debilitating neurologic condition. The approval of Nuedexta also marks AVANIR’s transition toward becoming a commercial enterprise, ready to support the successful launch of the first FDA-approved treatment for PBA. We expect that Nuedexta will be available by prescription during the first quarter of 2011.
Dr. Nicholas LaRocca, MS Society, Vice President of Healthcare Delivery and Policy Research, said:
This FDA approval represents a significant step forward for people who live with the debilitating effects of PBA. For people who experience unexplained bouts of inappropriate laughing or crying, this new therapy has the potential to substantially help both them and their families.
Randall Kaye, MD, Chief Medical Officer, Avanir Pharmaceuticals, said:
Today’s approval of NUEDEXTA is a testament to the conviction of the patients and researchers who participated in our studies and represents over 10 years of research and development by our dedicated employees. We are very pleased to bring the first proven treatment option to the many patients in the U.S. living with PBA. I would like to thank FDA for working closely with us to make NUEDEXTA available.
Dr. Erik Pioro, Cleveland Clinic, Director of ALS Section, also a researcher in the Nuedexta clinical trials, said:
PBA is a disabling neurologic condition commonly found in patients with underlying neurologic diseases or injuries. These patients frequently experience embarrassment due to their unpredictable emotional outbursts, leading to disruption of their interpersonal relationships and social isolation. As a physician who has cared for many patients with PBA, I am pleased that there is now a safe and effective treatment option for PBA that may help these patients regain more control over their daily lives and live with dignity.
Patients with PBA are often misdiagnosed with depression. PBA patients with unpredictable and involuntary displays of emotion may become anxious and extremely embarrassed, especially when there are many people around. In some cases the individual may avoid social situations. This deliberate move towards isolation may seem like a sign of depression. However, some patients do have both, PBA and depression.
According to Avenir, over 1 million Americans are moderately or severely affected with PBA.
Avenir, in its PBA web site writes:
Although PBA occurs secondary to neurologic diseases and brain injuries, it is a distinct neurologic disorder, which can be diagnosed and treated separately from an underlying neurologic disease or injury.
Source: Avenir Pharmaceuticals Inc.
Written by Christian Nordqvist