FDA Grants Breakthrough Designation to Novel Schizophrenia Drug


The therapy was found to be generally well tolerated among treated patients, with similarities to placebo in discontinuation rates, restlessness symptom rates, and changes in metabolic metrics.


What exactly does this mean? Is this significant or just another let down?


I think it’s in phase 2. But if it makes it, it could be another iti-007.


What do you mean by another iti-007?


Very low side effects. Supposedly.

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This is interesting:

SEP-363856 holds promise to be the first agent for the treatment of schizophrenia that does not bind to dopamine 2 (D2) receptors —

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“For more than 60 years, the treatment of schizophrenia has focused on blocking dopamine receptors. Finding a schizophrenia medication that works outside of a direct action on the dopamine system would be highly desirable, and SEP-363856 may represent such a breakthrough. The results of the Phase 2 trial are consistent in showing improvement in positive and negative symptoms, without the traditional side effects associated with dopamine blockers,” said Shitij Kapur, M.B.B.S, Ph.D., F.R.C.P.C., F.Med.Sci., Dean Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne. “The results need to be replicated in further studies and broader populations, but, if these results hold, it could be a remarkable advance for patients and health care providers, as well as a great new avenue for exploration of new scientific mechanisms for psychotic disorders.”


Well, I must say that I do find this one exciting. No binding to dopamine - could this have an effect on motivation I wonder?


It’s a race to be first, as Naben also has no binding to dopamine receptors, nor does Evenamide and they are all entering or in phase 3. However, it looks like both of those will be add-ons and SEP-363856 will be a primary med.

Oh and I’m not sure but I think MIN 101 as well. Also in phase 3.


Pimavanserin as well.

All of these stand to be approved in the next 2-5 years.


This is a link about Sunovion Pharm. presentations from May 2, 2019.
It mentions it hopes for a Phase 3 trial start of SEP-363856 within the next year.
Sunovion comments May 2, 2019

“The Phase 3 program for SEP-363856 is expected to be initiated in FY2019 (April 1, 2019 – March 31, 2020).”


I hope it works out. I like to see something that’s not a 30 day injection of a drug already on the market.

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this drugs touching nmda receptors?


Although the exact mechanism of action is unknown, SEP-363856 is believed to activate TAAR1 (trace amine-associated receptor 1) in addition to 5-HT1A (serotonin 1A) receptors.