FDA approves Sunovion’s Latuda to treat some cases of bipolar disorder


Sunovion Pharmaceuticals Inc., a Marlborough based drug company now owned by Dainippon Sumitomo Pharma Co. Ltd. of Japan, said that it has received regulatory approval to market its Latuda drug for additional uses in the United States.

Latuda was initially approved the US Food and Drug Administration as a treatment for adults with schizophrenia in 2010 and launched in 2011. Now the FDA has granted Sunovion permission to also market the drug as a treatment for adult patients with major depressive episodes associated with bipolar disorder, Sunovion said in a press release.

The FDA approval allows Latuda to be prescribed for those patients either as a single drug or as part of a drug cocktail with either Lithium or Valproate.

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Bipolar disorder, a mental illness characterized by debilitating mood swings, affects about 10.4 million American adults, according to the National Institute of Mental Health.

The value of the market that includes treatments for schizophrenia, bipolar disorder, and depression, has been estimated at $17.2 billion.

According to Sunovion, there are few treatments approved for bipolar depression. As a result, the FDA’s approval of Latuda for this condition is a significant event for both patients and the health care providers who treat them.

Sunovion’s press release included a statement from Masayo Tada, president and chief executive of Dainippon Sumitomo Pharma, or DSP.

“These two approvals represent a significant milestone not only for Sunovion and DSP, but for the millions of Americans who are living with bipolar disorder and struggling to manage the symptoms of bipolar depression,” Tada said. “We look forward to building on the strong foundation started in the United States to bring Latuda to other markets around the world. In addition, we are preparing for Phase 3 clinical trials for bipolar I disorder (bipolar depression) in Japan, an important market for us, where Phase 3 clinical trials for schizophrenia are already underway. This is part of Sunovion and DSP’s ongoing commitment to researching, developing, and commercializing new treatments for people with mental illness.”

The FDA’s approval for Latuda as a treatment for bipolar disorder requires additional language to the so-called black box warning on the drug’s label for schizophrenia. The black box warning is the agency’s most serious caution. All other medications used for the treatment of bipolar disorder include similar warnings, Sunovion noted.

In 2012, DSP reported that Sunovion had $1.4 billion in revenues, including $202 million in revenues from Latuda. Sunovion’s best known drug may be the sleep-aid Lunesta.

Sunovion was previously known as Sepracor Inc. In 2009, Sepracor was acquired by DSP for $2.6 billion. The following year, DSP changed Sepracor’s name to Sunovion.