FDA grants breakthrough designation for Sunovion's schizophrenia drug
Photo | Grant Welker
Sunovion's Marlborough headquarters
Marlborough drugmaker Sunovion has been granted a breakthrough therapy designation from the U.S. Food and Drug Administration for a new drug to treat schizophrenia.
That drug, in Phase 2 data from a trial that hospitalized patients with worsening schizophrenia, showed statistically significant and clinically meaningful improvement when treated with the drug as compared to a placebo.
Breakthrough therapy designation allows the development and review of new drugs treating serious or life-threatening conditions to be expedited upon clinical evidence the drug substantially improves those conditions.
The drug, named SEP-363856, was found to be generally well tolerated in patients, the company said.
Sunovion is developing the drug with New Jersey-based PsychoGenics.
The drug is being studied in a global development program for schizophrenia as well as Parkinson’s disease psychosis.
According to Sunovion, the drug functions differently than currently marketed antipsychotics, but the exact mechanism is unknown, the company said.
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