Sunovion sees positive results of bipolar treatment study

Photo | Grant Welker Sunovion's Marlborough headquarters

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Marlborough pharmaceutical firm Sunovion has announced promising results from a study for a bipolar disorder drug.

More than 300 patients in a global, randomized, double-blind, placebo-controlled study showed clinically meaningful improvement after six weeks of treatment compared to a placebo, the company said Monday.

The drug, given the name SEP-4199 while in the development process, will next head to a third phase of study to confirm findings just reported in the second phase. Sunovion doesn't yet have a timeline for submitting the drug for U.S. Food and Drug Administration approval for when it could hit the market, Sunovion's chief scientific officer, Dr. Kenneth Koblan, said in an interview.

The drug, a once-a-day oral pill, was well-tolerated by patients enrolled in the study, with relatively low rates of adverse events, Sunovion said. The study looked in particular at effects on depressive, not manic, episodes of bipolar disorder, with the former condition more common and typically less responsive to medication. An estimated 2.8% of American adults had bipolar disorder in the past year, and an estimated 4.4% of adults experience bipolar disorder at some time in their lives, according to the National Institutes of Health.

SEP-4199 has the potential to be the first such drug of its kind, known as a benzamide, to be used to treat mood disorders, according to Sunovion. The drug has been in studies for three years, the fastest the company has gone through such an investigatory phase, Koblan said. "It typically takes longer to do that early work," he said.

The company is committed to treating psychiatric and neurological conditions that can be unmet needs in psychiatry, Koblan said.

Sunovion already has another bipolar depression drug on the market, Latuda. Among other advances in the past six months, Sunovion has also won FDA approval for what it says is the first drug for Parkinson's disease which dissolves under the tongue, and demonstrated positive results in a study for a schizophrenia drug that has been granted a breakthrough therapy designation by the FDA.

"It's been a busy year for Sunovion," Koblan said.