Drug Receives FDA's Breakthrough Therapy Designation for Treating Individuals with Schizophrenia

The designation is intended to expedite the development and review of drugs for serious or life-threatening conditions when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on one or more clinically significant endpoints.

Officials with the FDA have granted Breakthrough Therapy Designation for SEP-363856 (Sunovion and PsychoGenics), a psychotropic agent for treating people with schizophrenia.

The designation is intended to expedite the development and review of drugs for serious or life-threatening conditions when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on 1 or more clinically significant endpoints.1

“Schizophrenia is a major public health challenge associated with persistent abnormalities in thinking, perception and behavior, as well as impairments in quality of life and functional skills, that affects approximately 2.4 million people in the US,” said Antony Loebel, MD, President and Chief Executive Officer at Sunovion, in a prepared statement. “Breakthrough Therapy Designation underscores the potential of SEP-363856 as a novel treatment for patients with schizophrenia, for whom few major advances in treatment have occurred since the advent of antipsychotic pharmacotherapy in the 1950s. Investigational studies to further evaluate the clinical benefit of SEP-363856 are in progress, and we look forward to working closely with the FDA on this important potential new therapy."

According to Sunovion, SEP-363856 does not bind to dopamine 2 (D2) or serotonin 2A (5-HT2A) receptors, which are thought to mediate the effects of currently available antipsychotic medicines. 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.

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The Breakthrough Therapy Designation for SEP-363856 was based on pivotal, Phase 2 data from Study SEP361-201, a randomized, placebo-controlled, double-blind, registration study. The data were presented by Sunovion at the American College of Neuropsychopharmacology (ACNP) annual meeting in December 2018, as well as data from Study SEP361-202, a 6-month, open-label, safety and tolerability extension study.

The SEP 361-201 study met its primary endpoint, demonstrating that hospitalized patients with acute exacerbation of schizophrenia treated with SEP-363856 showed statistically significant and clinically meaningful improvement in the Positive and Negative Syndrome Scale (PANSS) total score compared to placebo after 4 weeks of treatment (-17.2 vs. -9.7, respectively; p=0.001).

SEP-363856 also is being studied for Parkinson disease psychosis, as well as additional indications under consideration.

With the Breakthrough Therapy Designation, SEP-363856 is eligible for intensive guidance from the FDA on the drug development program and priority review.

Reference

SUNOVION AND PSYCHOGENICS ANNOUNCE THAT SEP-363856 HAS RECEIVED FDA BREAKTHROUGH THERAPY DESIGNATION FOR THE TREATMENT OF PEOPLE WITH SCHIZOPHRENIA [news release]. Marlborough, MA and Paramus, NJ; May 10, 2019: Sunovion website. https://news.sunovion.com/press-release/sunovion-and-psychogenics-announce-sep-363856-has-received-fda-breakthrough-therapy. Accessed May 10, 2019.