KETARX, a ketamine injection product, formulated by PharmaTher is designed to treat levodopa-induced dyskinesia in Parkinson’s disease.
Parkinson’s disease affects an estimated 1 million people in the U.S. and 10 million people worldwide. The global Parkinson’s disease treatment market is expected to grow from $5 billion in 2019 to $7.5 billion by the end of 2025. There is currently no cure for Parkinson’s disease, but some drug combinations are used to treat symptoms.
Following its recently announced Type C meeting with the FDA for advancing KETARX towards Phase 3 clinical development, PharmaTher said it is evaluating a Phase 3 clinical trial design to align with the FDA’s recommendations. The safety and efficacy results from its previously announced presentation of Phase I/II clinical study evaluating ketamine as a potential new treatment for LID-PD will be used to support the investigation of KETARX in a proposed Phase 3 clinical study.
PharmaTher also retains rights to US Patent No: 11,426,366 (expires May 2036), 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.
Fast Track designation aims to expedite the development and review of new drugs that are intended to treat serious or life-threatening conditions and demonstrate the potential to fill unmet medical needs.
Drugs that are granted this designation are given the opportunity for:
- More frequent meetings with the FDA to discuss the drug’s development plan and ensure the collection of appropriate data needed to support drug approval.
- More frequent written communication with the FDA about such things as the design of the proposed clinical trials and use of the biomarker.
PharmaTher noted that there can be no assurance it will proceed with the clinical development towards a Phase 3 clinical study and that the FDA will support any potential request for an expedited path to approval, such as Fast Track designation, or further development for ketamine in the treatment of Parkinson’s disease.