PharmaTher Holdings Ltd. announced the submission of a Fast Track Application to the U.S. Food and Drug Administration for KETARX (ketamine) for the treatment for levodopa-induced dyskinesia in Parkinson's disease. 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. The purpose is to get important new drugs to patients faster.

Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy. Drugs that are granted this designation are given the opportunity for more frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval; more frequent written communication with FDA about such things as the design of the proposed clinical trials and use of biomarker; Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met; and, Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. NDA review usually does not begin until the drug company has submitted the entire application to the FDA.

Following its recently announced Type C meeting with the FDA for advancing KETARX towards Phase 3 clinical development, the Company is evaluating a Phase 3 clinical trial design to align with the FDA's recommendations that would allow for a potential FDA approval. The safety and efficacy results from its previously announced presentation of the 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. Parkinson's disease is a debilitating disorder that affects an estimated 1 million people in the U.S. and 10 million people worldwide.

The global Parkinson's disease market is expected to grow from USD 5 billion in 2019 to USD 7.5 billion by the end of 2025. Ketamine is an FDA-approved N-methyl-D-aspartate receptor-modulating (NDMA) drug that is widely used as an anesthetic agent either alone or in combination with other anesthetic agents [Smith et al, 1987; Pacheco et al, 2014]. The possible therapeutic effect of low-dose ketamine on levodopa-induced dyskinesia was noted in a retrospective analysis of Parkinson's disease patients who received ketamine for pain relief.

During this analysis, it was observed that the patients experienced an improvement in LID lasting several weeks beyond treatment [Sherman et al, 2016]. These results were corroborated in a Phase I/II clinical study [presentation], and in a rodent LID model, and this possible effect has also been examined in a controlled study [Bartlett et al, 2016]. Ketamine may also have additional benefits in the treatment of pain [Niesters et al, 2014] and depression [Diamond et al, 2014; Murrough et al, 2013], which are frequent comorbidities of Parkinson's disease.