New Drug Application for Apomorphine Infusion Pump Submitted for Review
The NDA for SPN-830 is supported by data from an extensive development program that includes the phase 3 TOLEDO study and a supportive open-label study.
Parkinsonism
Ongentys Now Available as Add-On Treatment for Parkinson Disease
Ongentys is an oral, selective and reversible inhibitor of catechol-O-methyltransferase.
App Approval Provides Flexibility for Patients Treated With Abbott’s Neuromodulation Devices
The FDA has approved an iOS-compatible app designed to work in tandem with Abbott’s neuromodulation technologies. The Company hopes the app will eliminate the need for patients to carry a separate programmer device and improve remote care.
FDA Approves DBS Neurostimulation System With Brain Signal Tracking
The FDA has approved the Percept™ PC Deep Brain Stimulation (DBS) system (Medtronic) with BrainSense™ technology for neurological disorders.
Gocovri sNDA Under Review for Off Episodes in Parkinson Disease
The FDA has accepted for review the supplemental New Drug Application (sNDA) for Gocovri® (amantadine extended-release; Adamas Pharmaceuticals) for the treatment of off episodes in Parkinson disease (PD) patients receiving levodopa-based therapy.
Kynmobi Approved to Treat Off Episodes in Parkinson Disease
The Food and Drug Administration (FDA) has approved Kynmobi™ (apomorphine hydrochloride; Sunovion) for the acute, intermittent treatment of off episodes in patients with Parkinson disease (PD).
Ongentys Approved as Add-On Treatment for Parkinson Disease
The Food and Drug Administration (FDA) has approved Ongentys® (opicapone; Neurocrine Biosciences) as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson disease (PD) experiencing “off” episodes.
Isradipine Does Not Slow Early Parkinson Disease Progression
Change in total Unified Parkinson’s Disease Rating Scale score similar for isradipine versus placebo.
Anticholinergic Burden Tied to Adverse Effects in Middle Age
Identification of at-risk populations varies by scale used, which could impact clinical practice.
Infinity DBS System Gains Expanded Approval for Parkinson Disease Management
The FDA has approved an expanded indication for the Infinity™ Deep Brain Stimulation (DBS) system (Abbott) to include targeting the internal globus pallidus, which may lead to symptom improvement in patients with Parkinson disease.
