The U.S. Food and Drug Administration (FDA) is encouraging scientists and drug developers to use an alpha-synuclein seed amplification assay (synSAA) to improve the development and efficiency of clinical trials seeking to delay or prevent the development of Parkinson’s and other neurodegenerative diseases that share toxic clumps of that protein…

The U.S. Food and Drug Administration (FDA) said it needs more information before deciding whether to approve the apomorphine infusion pump SPN-830 for the treatment of Parkinson’s disease, according to a press release from the device’s developer Supernus Pharmaceuticals. In a complete response letter (CRL) to…

IRLAB Therapeutics is taking steps in preparation for a Phase 3 clinical program of mesdopetam, an experimental medicine for the treatment of levodopa-induced dyskinesia in Parkinson’s disease. The Swedish company is consulting with two advisors, Clintrex and ProPharma Group, to gather the documentation needed to request…

Note: This story was updated Sept. 20, 2023, to reflect that Acadia is working on Nuplazid’s development as a treatment for schizophrenia. The U.S. Food and Drug Administration (FDA) has updated the prescribing label for Nuplazid (pimavanserin) — an approved therapy for Parkinson’s disease-related hallucinations and delusions…

The U.S. Food and Drug Administration (FDA) is asking for more information concerning the safety of  IPX203, an extended-release oral formulation of carbidopa and levodopa, before a final approval decision in treating Parkinson’s disease symptoms can be made. In a complete response letter to Amneal Pharmaceuticals,…

The second version of the MyoCycle, a functional electrical stimulation (FES) bike designed for people with motor disabilities, including Parkinson’s disease, is now available in the U.S. after winning the needed go-ahead from federal regulators. The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to developer…

The U.S. Food and Drug Administration (FDA) has given positive feedback to Annovis Bio’s plans to start two Phase 3 clinical trials of buntanetap (ANVS401) as an oral therapy for early- and late-stage Parkinson’s disease. The feedback followed a review of data from a Phase 2 clinical trial showing significant…

The U.S. Food and Drug Administration (FDA) has told Sunovion Pharmaceuticals that it is unable to approve APL-130277 (apomorphine sublingual film) in its present form for the treatment of Parkinson’s disease “off”  periods. Sunovion submitted new drug application for APL-130277 in April 2018. Now the FDA has now…

Acorda Therapeutics has asked the European Medicines Agency to approve Inbrija (CVT-301) to reduce the periods when the standard Parkinson’s treatment carbidopa/levodopa is not working. Inbrija is a self-administered, inhaled levodopa therapy. Acorda developed it to reduce the time when standard levodopa treatment wears off — periods known as off times.

The U.S. Food and Drug Administration (FDA) has agreed to review a request by Adamas Pharmaceuticals to approve ADS-5102 (amantadine hydrochloride) extended-release capsules to treat levodopa-induced dyskinesia (LID) in patients with Parkinson’s disease (PD). The company submitted the request as New Drug Application (NDA) to the FDA in October. A…