FDA Approves Trial for New Schizophrenia Treatment Add-on

The application approved for testing is for a treatment known as NW-3509, an "add-on therapy" for schizophrenia.

The United States Food and Drug Administration (FDA) has approved the first in-man trial for a potential schizophrenia therapy from Newron Pharmaceuticals.

The investigational new drug (IND) application was submitted on July 5th, 2011.

Newron Pharmaceuticals is a research company whose primary focal point involves discovering and developing new approaches to CNS disorders and pain therapy; the application approved for testing is for a treatment known as NW-3509, the purpose of which is reported as an “add-on therapy” for schizophrenia.

According to Ravi Anand, M.D., Newron’s Chief Medical Officer, “Newron has discussed with regulatory authorities innovative pathways to expediting the early clinical development of NW-3509 that will allow assessment of efficacy (PoC) and safety to be conducted at an early stage.”

NW-3509 is the first voltage gated sodium channel (VGSC) modulator being tested to treat the psychiatric disorder.

The treatment “selectively inhibits voltage gated sodium channels and normalizes aberrant neuronal firing and glutamatergic hyperactivity that have been implicated in the patho-physiology of schizophrenia,” reported Anand.

Anand and his fellow researchers believe that, as the treatment has the ability to alter these factors in schizophrenia, it will enhance existing drugs that block serotonergic and dopaminergic, which are the “main stay of schizophrenia, but have been shown to be associated with sub-optimal efficacy in a large number of patients.”

“Therefore,” continued Anand, “the addition of NW-3509 to the current treatments may extend the benefits in symptoms of psychosis, reduce their dose, and significantly reduce the side effects of these drugs.”

Anand went on to state that the approval of NW-3509 “is extremely important as it allows Newron to move forward with the development of this exciting new approach to treating a major mental disorder.”