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news.Newron Pharmaceuticals, an Italy-based developer of central nervous system and pain therapies, has filed NW-3509 investigational new drug (IND) application with the US Food and Drug Administration (FDA) as a treatment for schizophrenia.
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The IND application seeks permission to conduct clinical trial in human non-patient volunteers.
Prior to submitting the IND, the company has conducted meeting with the FDA and the Medicines and Healthcare products Regulatory Agency (MHRA) so as to take suggestions and recommendations from the agencies in connection with the filing.
In different studies, NW-3509 showed reduction in pre-pulse inhibition (PPI), that has shown to be abnormal in patients with schizophrenia.
Newron chief medical officer Ravi Anand said NW-3509 provides an approach to the treatment of patients with psychosis who are not responding to the currently available treatments, that largely block dopaminergic and serotonergic receptors.
"NW-3509, instead, targets voltage gated sodium channels, providing the opportunity to normalize aberrant neuronal firing and glutamatergic hyperactivity, that have been implicated in the patho-physiology of schizophrenia," Anand said.
"Therefore, the addition of NW-3509 to the current treatments may extend the benefits in symptoms of psychosis and significantly reduce the side effects experienced by patients."