Ketamine for Parkinson's Disease, PharmaTher Holdings Announces Grant of U.S. Patent To Cover It

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 announced that the US States Patent and Trademark Office (“USPTO”) granted US Patent No: 11,426,366.

The patent is titled “Compositions and Methods for Treating Motor Disorders,” which includes claims intended 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.

“We are pleased with the USPTO grant of the patent covering ketamine in the treatment of Parkinson’s disease and motor disorders," said Fabio Chianelli, CEO of PharmaTher. "The US patent strengthens our intellectual property portfolio covering novel uses and delivery forms of ketamine."

Ketamine Treatment For Patients With Parkinson’s Disease

Parkinson’s disease is a debilitating disorder 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 agreement on pursuing approval under the 505(b)(2) regulatory pathway with a potential Phase 3 clinical study,” said Chianelli.

Recently, PharmaTher announced positive efficacy and safety data from a Phase 1/2 clinical study of ketamine in the treatment of levodopa-induced dyskinesia (“LID”) in Parkinson’s disease via a late-breaking abstract presentation, titled “Subanesthetic infusion of ketamine produces a long-term reduction in levodopa-induced dyskinesia” at the MDS International Congress of Parkinson's Disease and Movement Disorders.

Highlights Of The Study

“The Phase 1/2 study was an open-label, dose-finding trial to test the safety, tolerability, and pharmacokinetics of low-dose ketamine infusion to treat levodopa-induced dyskinesia in Parkinson’s disease and to find an effective dose range suitable for outpatient use,” reads a press release.

What’s Next?

“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 for the Company’s proprietary ketamine intravenous product, KETARX, approved for Parkinson’s disease under the 505(b)(2) regulatory pathway.

Photo: Courtesy Of Louis Reed On Unsplash