Patient Assistance Program Launched for Nuedexta

by Amy Madsen on Fri, 2012-06-08 02:26

Eligible individuals with a diagnosis of pseudobulbar affect (uncontrolled laughing or crying) now can gain free or low-cost access to a drug that treats it

Article Highlights:
  • People with amyotrophic lateral sclerosis (ALS) who experience pseudobulbar affect and who meet a set of criteria now can get Nuedexta at low or no cost under Avanir Pharmaceuticals' new Patient Assistance Program.
  • Pseudobulbar affect is a neurologic condition that sometimes occurs in people with ALS, causing unwanted episodes of crying or laughing not correlated with actual mood.

A new Patient Assistance Program can help people with a diagnosis of pseudobulbar affect (PBA) get a medication designed to treat the condition at low or no cost.

PBA is a neurologic condition that sometimes occurs in people with amyotrophic lateral sclerosis (ALS), causing unwanted episodes of crying or laughing that aren't correlated with actual mood. Although not harmful, these episodes can be upsetting and embarrassing, and people sometimes avoid social situations because of them.

Under the program, eligible individuals with ALS can receive a six-month supply of the drug Nuedexta free of charge, and may qualify for ongoing assistance with periodic verification of eligibility.

Nuedexta developer Avanir Pharmaceuticals, headquartered in Aliso Viejo, Calif., revealed details of the program June 5, 2012, in a press release. Nuedexta is the only medication approved by the U.S. Food and Drug Administration to treat PBA.

Financial assistance available

The Patient Assistance Program is part of Avanir’s Nuedexta Patient Services for patients and health care providers. People seeking financial and treatment support can use this service to access health insurance plan assistance, including drug benefit verification; financial and co-pay assistance; and educational information about pseudobulbar affect and Nuedexta.

Financial assistance includes:

  • a Co-Pay Assistance Program for people with private insurance, which sets a $30 limit to the co-pay required to purchase Nuedexta;
  • an Out-of-Pocket Assistance Program for people with Medicare Part D that can lessen out-of-pocket expenses for the medication; and
  • a Patient Assistance Program that may help people who have limited or no prescription drug coverage obtain Nuedexta free of charge.

Nuedexta reduces unwanted laughing and crying

Nuedexta is a combination of two drugs: dextromethorphan hydrobromide and quinidine sulfate. Dextromethorphan acts in the central nervous system to reduce the frequency of unwanted episodes of laughing or crying, although the precise mechanism by which it works is unknown. Quinidine increases blood levels of dextromethorphan by interfering with its breakdown in the body. (Nuedexta does not treat the underlying causes of ALS.)

Avanir reported in 2010 that a phase 3 trial of Nuedexta (former versions of which were known as Neurodex, Zenvia and AVP923) included approximately 300 participants with PBA secondary to either ALS or multiple sclerosis. The investigators found the drug reduced the number of episodes of unwanted laughing or crying compared to a placebo, and that it was generally safe and well-tolerated.

Learn more about the program

People with ALS who experience pseudobulbar affect and who have questions about Nuedexta or the assistance program, can contact Nuedexta Patient Services at (855) 468-3339, Monday through Friday, between the hours of 9 a.m. and 7 p.m. Eastern time. Information also is available on Neudexta's website.

People considering taking Nuedexta should discuss any current health problems and medications, as well as the possible benefits and risks of this drug, with a physician.

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