PharmaTher has submitted a fast track application for Ketarx (ketamine) to the US Food and Drug Administration (FDA) to treat levodopa-induced dyskinesia in Parkinson’s disease (LID-PD).
The FDA-approved N-methyl-D-aspartate receptor-modulating (NDMA) drug ketamine is leveraged as an anaesthetic agent either alone or along with other anaesthetic agents.
Go deeper with GlobalData
The company stated that the previously announced data from the Phase I/II clinical trial of ketamine to treat LID-PD will be used to support the evaluation of Ketarx in a proposed Phase III clinical trial.
The dose-finding, open-label Phase I/II trial was designed to assess the tolerability, pharmacokinetics and safety of low-dose ketamine infusion for the treatment of LID-PD, and to find an effective dose range suitable for outpatient use.
Measurements taken on the unified dyskinesia rating scale (UDysRS) demonstrated a reduction of 51% during infusion 2, 49% at three weeks and 41% at three months from baseline after receiving treatment with ketamine.
See Also:
They also showed a reduction of 27% at the time of infusion 2, 28% at three weeks and 5% at three months.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataPharmaTher noted that the maximum tolerated infusion rate ranged from 0.20mg/kg/h to 0.30mg/kg/h, depending on either discomfort caused due to dissociation or hypertension.
100% of the ketamine-treated participants had dyskinesia reduction measured by the UDysRS. No adverse events were observed after infusion.
PharmaTher is now assessing the design of the Phase III trial to align with the recommendations of the FDA.
In January 2023, the company applied for orphan drug designation from the US FDA to treat Rett Syndrome, a rare genetic neurological disorder.
