PharmaTher Files With FDA For Orphan Drug Designation In Use Of Ketamine For ALS
PharmaTher Holdings (CSE: PHRM) this morning announced that it has filed with the US FDA for orphan drug designation as it works to further study the uses of ketamine. The latest filing pertains to the use of ketamine to treat Lou Gehrig’s disease, which is formally known as ALS, or amyotrophic lateral sclerosis.
Lou Gehrig’s disease is a neuromuscular disease, which currently has a life expectancy of just two to six years after initial diagnosis. The disease effectively causes upper and lower motor neurons to die, causing the brain to lose function of muscle movement. As the disease progresses patients lose voluntary muscle action, causing the inability to speak, eat, move and breathe. There is currently no cure for the disease.
Initial research conducted on ketamine has indicated that it has the potential to increase life expectancy of those impacted by the disease, slowing the progressive loss of muscle. Preclinical work has demonstrated that the compound preserves muscle function in advancing ALS, and improves life expectancy when administered early in the stages of muscles decline.
“Ketamine has tremendous potential for not only mental illness and pain disorders but also for neurodegenerative diseases such as ALS. Our FDA orphan drug application for ketamine to treat this life-threatening disease complements our patent portfolio that aims to protect the proposed method of use and dosage claims of ketamine for ALS. Although patent protection or market exclusivity could last beyond 2040, our intention to seek orphan drug designation is to leverage the expedited regulatory and clinical development incentives offered by the FDA for repurposed drugs in treating rare diseases.”
Fabio Chianelli, Chief Executive Officer of PharmaTher
PharmaTher Holdings last traded at $0.40 on the CSE.
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