Based on the data, the FDA has concluded that the drug's benefit continues to outweigh its risks for patients with hallucinations and delusions associated with Parkinson's disease psychosis.
Nuplazid, a non-dopaminergic, selective serotonin inverse agonist, targets 5-HT2A receptors that are thought to be involved in Parkinson's disease psychosis.
The film is a new formulation of the dopamine agonist apomorphine, intended for rapid conversion from the OFF to the ON state; it has been studied to treat motor OFF episodes up to 5 times a day.
Previous research has suggested a genetic and functional link between IBD and PD, however evidence regarding this association has been limited.
By 2 years, 30% of patients had increased their levodopa dose by ~300mg, indicating that treatment with Gocovri may allow for further levodopa optimization despite the occurrence of dyskinesia.
The NDA submission included data from Phase 3, 12-week, randomized, double-blind, placebo-controlled, parallel-group study (CTH-300) that enrolled patients with levodopa-responsive Parkinson's disease complicated by OFF episodes.
The approval of Osmolex ER was based on bioavailability studies comparing Osmolex ER to immediate-release amantadine.
The difference in score change for movement disorder from baseline to 30 minutes post-dose between the apomorphine and placebo group was 7.6 (P=0.0002).
Gocovri is indicated for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications.
The safety and efficacy of Gocovri was seen in two Phase 3 controlled trials in Parkinson's disease patients with dyskinesia.
Neurologists have linked medications used for Parkinson's disease with impulse control disorders such as pathological gambling, compulsive buying, hypersexuality, and binge eating in some patients.
Acadia announced that the Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) voted in favor (12-2) that the benefits of Nuplazid (primavanserin) outweighed the risks for the treatment of psychosis associated with Parkinson's' disease.
Declines in cognition could have a greater impact on the ability of Parkinson's disease patients to converse than physical impairment, according to research published online in the Journal of Parkinson's Disease.
Researchers from University College London have developed an algorithm that uses medical data to predict a five-year risk of dementia, according to a report published online January 21 in BMC Medical.
Rivastigmine shows potential in reducing the risk of falls among patients with Parkinson's disease, according to new research published online January 12 in The Lancet Neurology.
Apigenin, a flavonoid found in some spices and herbs, may improve neuron formation and strengthen connections between brain cells, researchers from D'Or Institute for Research and Education reported.