PharmaTher Applies for Fast Track for KETARX™ (Ketamine) Treatment of Parkinson’s

 PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, today announced the submission of a Fast Track Application to the U.S. Food and Drug Administration (“FDA”) for KETARX™ (ketamine) for the treatment for levodopa-induced dyskinesia in Parkinson’s disease (“LID-PD”).

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.

https://www.biospace.com/article/releases/pharmather-holdings-submits-fast-track-application-to-fda-for-ketarx-ketamine-for-the-treatment-of-parkinson-s-disease/