The US Patent and Trademark Office USPTO granted US Patent No: 11,426, 366 to PharmaTher Holdings Ltd. PHRRF PHRM, a pharmaceutical company focused on developing novel uses and delivery forms of ketamine to treat mental health, neurological and pain disorders.
The patent is titled Compositions and Methods for Treating Motor Disorders, which includes claims to cover ketamine in the potential treatment of Parkinson's Disease and motor disorders that cause involuntary or uncontrollable movement or actions of the body.
Fabio Chianelli, CEO of PharmaTher said that they were pleased with the USPTO grant of the patent covering ketamine in the treatment of Parkinson's disease and motor disorders. The US patent strengthens our intellectual property portfolio, covering novel uses and delivery forms of ketamine. Parkinson's disease is a debilitating disease that affects an estimated 1 million people in the U.S. and 10 million people worldwide.
We are advancing the clinical development of ketamine in the treatment of levodopa-induced dyskinesia in patients with Parkinson's disease, and we are seeking FDA approval for approval under the 505 b 2 regulatory pathway with a potential Phase 3 clinical study, said Chianelli.
A late-breaking abstract presentation by PharmaTher titled Subanesthetic infusion of ketamine leads to a long-term reduction in levodopa-induced dyskinesia at the MDS International Congress of Parkinson's Disease and Movement Disorders has recently been announced as a positive efficacy and safety data from a Phase 1 clinical study of ketamine in the treatment of levodopa-induced dyskinesia in Parkinson s disease.
The Phase 1 2 study was an open-label, dose-finding trial to assess safety, tolerability and pharmacokinetics of low-dose ketamine infusion to treat levodopa-induced dyskinesia in Parkinson's disease and find an effective dose range suitable for outpatient use, reads a press release.
Based on these data, PharmaTher is preparing to engage the FDA to establish the next steps for a planned Phase 3 clinical study to allow the Company s proprietary ketamine intravenous product, KETARX, approved for Parkinson s disease under the 505 b 2 regulatory pathway.