Sunovion Pharma is calling it quits on dasotraline, a dopamine and norepinephrine reuptake inhibitor it was developing for binge eating disorder and attention deficit hyperactivity disorder (ADHD). It withdrew New Drug Applications for both indications and stopped development of the program.
MARLBOROUGH, Mass.--(BUSINESS WIRE)--Sunovion Pharmaceuticals Inc. (Sunovion) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for dasotraline, a novel dopamine and norepinephrine reuptake inhibitor (DNRI), for the treatment of patients with moderate-to-severe binge eating disorder (BED). Dasotraline’s pharmacokinetic profile, characterized by an extended half-life, supports its potential for sustained control of moderate-to-severe BED symptoms.
Sunovion’s application to market dasotraline for the treatment of attention-deficit hyperactivity disorder (ADHD) has been rejected by US regulators.
The US Food and Drug Administration (FDA) have rejected American pharma firm Sunovion’s application to market dasotraline for the treatment of Attention Deficit Hyperactive Disorder (ADHD).
MARLBOROUGH, Mass.--(BUSINESS WIRE)--Sunovion Pharmaceuticals Inc. (Sunovion) today announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter for the New Drug Application (NDA) for dasotraline, a novel dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI), for the treatment of attention-deficit hyperactivity disorder (ADHD).
Sunovion Pharmaceuticals Inc. (Sunovion) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for dasotraline, a novel dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) being evaluated for the treatment of attention deficit hyperactivity disorder (ADHD) in children, adolescents and adults.