PharmaTher Granted US Patent Protection for Ketamine
PharmaTher has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) covering use of the painkiller ketamine for the treatment of Parkinson’s disease and motor disorders that cause uncontrolled, involuntary movements.
A Notice of Allowance means the USPTO has decided to issue the requested patent, titled “Compositions and Methods for Treating Motor Disorders.”
“The US Notice of Allowance of the Patent Application not only adds to our intellectual property portfolio covering novel uses, delivery forms and formulations of ketamine, but it also strengthens our commercial opportunities with ketamine as a potential treatment for Parkinson’s disease and movement disorders,” Fabio Chianelli, CEO of PharmaTher, said in a press release.
The patent should be issued later this year.
The company is planning a Phase 3 clinical trial to continue to test its proprietary ketamine (sold as Ketarx) for the treatment of levodopa-induced dyskinesia — the uncontrolled, involuntary movements that affect as many as 80% of Parkinson’s patients following treatment.
The results of this trial would support a possible approval of ketamine — an FDA approved anesthetic and pain-relieving agent — for the treatment of Parkinson’s disease via a new drug application pathway.
The new trial comes on the heels of positive topline results from a Phase 2 study (NCT04912115) that evaluated the safety, tolerability and efficacy of an intravenous (into-the-vein) low-dose ketamine infusion for treating levodopa-induced dyskinesia.
Participants, ages 30 to 85, were assigned randomly to receive either low-dose ketamine or midazolam — a sedative used for anesthesia, troubled sleep, and severe agitation — for about two months.
Top-line data showed that all patients treated with the ketamine infusion for the study period had a reduction in dyskinesia, as measured by the Unified Dyskinesia Rating Scale.
Also, the low-dose ketamine was well-tolerated, with no serious side effects reported.
According to PharmaTher, the findings are in agreement and further confirm a prior report of five cases of Parkinson’s disease patients where low-dose ketamine reduced levodopa-induced dyskinesia.
The results from the Phase 2 study will help determine the patient enrollment target for the Phase 3 trial. The final data should be available by September, after which it will be presented at a medical congress.