FDA approves new add-on drug to treat off episodes in adults with Parkinson’s disease

[Farooqji]

fda.gov/news-events/press-a...

[chartist]

In the following study, it is shown that the most common adverse drug reactions for istradefylline (the drug mentioned) are dyskinesia and hallucinations.

ncbi.nlm.nih.gov/pubmed/302...

Reduction in off-time was observed in 38.2% of patients.

Art

[park_bear in reply to chartist]

From the full text:

"ADRs occurred in 20.8% (99/476) of patients (Table 2). The most common ADRs were dyskinesia (5.0%, 24/476), hallucination(3.4%, 16/476), visual hallucination (1.3%, 6/476), and somnolence (1.1%, 5/476). Dyskinesia worsened in 10.6% (19/180) of patients who were already dyskinetic at baseline

...

The results of the physician’s assessment of off-time, off-time symptoms, and motor dysfunction are shown in Figure 1. Off-time was reduced in 38.2% (182/476) of patients. Off-time symptoms and motor dysfunction were ‘markedly improved’ and ‘improved’ in 44.7% (213/476) and 48.5% (231/476) of patients, respectively"

[chartist in reply to park_bear]

I wonder if the worsening of dyskinesia in people who already had it or the starting of dyskinesia in people who did not previously have it, was reversible upon stopping the drug? That seems like it would have been an important point to cover. The same with the hallucinations, were they reversible upon stopping the drug?

Art

[chartist]

There may be more to this drug than what was initially apparent! Apparently, postural deformities associated with the use of dopamine agonists may be responsive to istradefylline initiation :

journals.viamedica.pl/neuro...

Art