International Alliance

Used across the whole answer

✓Supports this

“Nuedexta's approval for pseudobulbar affect covers the United States only.”

States the approval position directly. The page also records that Nuedexta was approved by the European Medicine Agency after its 2010 US approval and that the approval was later withdrawn for commercial reasons, and its country table lists the USA alone.

While clinical trials have shown promising results, Nuedexta is still only approved for the treatment of PBA, and only in the United States.

Current Status

✓Supports this

“Using Nuedexta for speech and swallowing is off-label, because its only approval is for pseudobulbar affect.”

Says the approval covers pseudobulbar affect only, and only in the United States, in the same section that describes the speech and swallowing trial. It describes what ALSUntangled reviewed as off-label use of Nuedexta for improving bulbar function. That sentence is not quoted here because it carries a spelling error on the page.

✓Supports this

“In a 2017 randomised crossover trial in 60 people, with 28 day periods, people rated their own bulbar function better on Nuedexta. A preliminary result from another trial showed improved bulbar physiology. An independent review supports considering it for bulbar problems and wants more research.”

Describes the trial in detail: 60 people with ALS/MND, randomised, double-blind and crossover, 28 days on Nuedexta or placebo, a two week break, then the groups swapped. It records that ALSUntangled reviewed the same use and supports considering Nuedexta for bulbar dysfunction with or without pseudobulbar affect, and it adds that more research is warranted.

In 2017, researchers recruited 60 people with ALS/MND for a randomized, double-blind, cross-over clinical trial looking at if the drug could improve speech and swallowing and reduce drooling.

Current Status

✓Supports this

“In the approval trials, people taking Nuedexta rated their quality of life and their relationships higher than the comparison groups did.”

Describes the first pivotal trial, in which people taking Nuedexta scored lower on the pseudobulbar affect symptom scale than people taking either component alone, and also rated their quality of life and relationships higher. The page does not quantify the size of that difference.

Participants taking Nuedexta also rated their quality of life and quality of relationships higher than those in the other two groups.

Study 1:

Used across the whole answer

Further reading

Overview of how Nuedexta is used in ALS