PharmaTher Sees $0.75-$2.2B Opportunity in Ketamine-Based LID Treatment for Parkinson's
PharmaTher, a biotech company, sees a substantial market opportunity for a ketamine-based treatment in Levodopa-Induced Dyskinesia (LID) in Parkinson's Disease (PD), estimated between US$0.75 billion and US$2.2 billion. The company is actively pursuing this opportunity with its LID-PD program.
PharmaTher is developing ketamine as a treatment for LID-PD, aiming to use the 505(b)(2) regulatory pathway to reduce development risk, cost, and timelines. The company plans to request a Pre-Phase 3 meeting with the FDA to clarify the Phase 3-enabling path and confirm key components of a registrational plan for LID-PD. PharmaTher's LID-PD program has exclusive patent coverage until 2036 for ketamine in Parkinson's and related motor disorders.
The company expects to pursue FDA acceptance for a single, well-controlled Phase 3 study to support an NDA submission. PharmaTher will utilize its FDA-reviewed Chemistry, Manufacturing and Controls (CMC) foundation to streamline development for its LID-PD program. Near-term milestones include submitting a Pre-Phase 3 FDA meeting request and finalizing the pivotal protocol. The company is also engaged in active discussions with prospective pharmaceutical partners for potential acquisition or licensing of the program.
PharmaTher's LID-PD program, focusing on ketamine as a treatment, has significant market potential and strong regulatory support. The company's near-term goals and exclusive patent coverage position it well for success in this therapeutic area.
