The authors found that the compounds known as phenylindanes inhibited the aggregation of the amyloidgenic proteins beta-amyloid and tau.
The researchers observed a correlation between removal of the appendix decades before PD onset and a lower risk for PD, especially for those living in rural areas.
The open-label safety study included patients from 3 Gocovri dyskinesia efficacy trials (N=223) and evaluated the long-term safety and tolerability of the treatment.
In order to determine the risk of PD associated with various β2‐adrenoreceptor drugs, the study authors assessed United States Medicare beneficiary data from 2009.
The researchers found that a high-risk anticholinergic prescription was listed for 6.2% of visits of older adults between 2006 and 2015, representative of 14.6 million total visits nationally.
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.
The association with other common tests for PD diagnostics, including smell, ultrasound, and nonmotor symptoms, was also examined. Data were included for 29 PD patients after initial diagnosis and 19 control subjects.
Nuplazid, a non-dopaminergic, selective serotonin inverse agonist, targets 5-HT2A receptors that are thought to be involved in Parkinson's disease psychosis.
The 5-year cumulative incidence of ICDs was 46.1% in 306 patients without ICDs at baseline (DA ever-users, 51.5%; DA never users, 12.4%).
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.
The clinic claims its unapproved therapies can treat a number of serious diseases and conditions, including Parkinson's disease, amyotrophic lateral sclerosis (ALS), chronic obstructive pulmonary disease (COPD), heart disease, and pulmonary fibrosis.
Concerns over Nuplazid were initially voiced in a CNN article in early April which reported that the drug had been associated with over 700 deaths since its launch in March 2017.
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 application assesses 3 key balance metrics: (1) double stance, (2) right tandem stance, and (3) left tandem stance.
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 researchers observed a significant decrease in total alpha-synuclein in tears from PD patients relative to healthy controls (423.12 ± 52.6 versus 703.61 ± 136.4 pg/mg tear protein). PD patients also had significantly increased oligomeric alpha-synuclein relative to controls (1.45 ± 0.31 versus 0.27 ± 0.07ng/ng tear protein).
Inbrija (previously known as CVT-301) is a self-administered, orally inhaled levodopa; it is designed to deliver a precise dose of a dry powder formulation of L-dopa to the lung.
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 FDA's approval was based on results from the 'Intrepid' study, the first multi-center, prospective, double-blind, randomized sham-controlled study of DBS for Parkinson's Disease in the U.S.
The researchers found that the ACB showed the strongest and most consistent dose-response relationships with risks of all four adverse outcomes compared with ARS and DBI-Ach, especially among those aged 65 to 84 years.
Dependent on further input from the Data Safety Monitoring Board (DSMB) and the Food and Drug Administration (FDA), the Company stated that they intend on moving forward with the study and expect to report results in the first quarter of 2018.