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Marlborough company Sunovion Pharmaceuticals Inc. has begun its in-human clinical trials for a drug to treat generalized anxiety disorder.
The clinical development process is in partnership with Otsuka Pharmaceutical Development & Commercialization, Inc., based in Tokyo, Japan.
The first patient has now been selected for the randomized clinical trial, according to a Wednesday press release from Sunovion. The drug, ulotaront, is also in clinical studies for treatment of schizophrenia and major depressive disorder, and the trial process for its treatment of generalized anxiety disorder adds a third potential treatment indication for the drug.
“Generalized anxiety disorder is a chronic condition characterized by excessive anxiety or worries, sleep disturbances, changes in appetite and impairment of social and occupational activities, which can have a profound impact on nearly all aspects of an individual’s life,” Dr. Armin Szegedi, senior vice president, chief medical officer at Sunovion, said in the press release. “Preliminary data from preclinical and clinical studies of ulotaront suggest an anxiety-reducing effect, which we aim to understand further in patients with GAD.”
An estimated 5.7% of U.S. adults will experience generalized anxiety disorder at some time in their lives, according to the National Institute of Mental Health.
Ulotaront was granted breakthrough therapy designation by the U.S. Food and Drug Administration for the treatment of schizophrenia in 2019, a designation which has the aim of expediting a drug development process.
“With the expansion of ulotaront’s clinical development program to a third indication, we are making significant progress towards goals we set for co-development and co-commercialization with Sunovion to address areas of high unmet need for people living with serious mental illnesses,” Dr. John Kraus, executive vice president and chief medical officer at Otsuka, said in the press release.
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