Sunovion announces acceptance by FDA of NDA for Dasotraline to treat Binge Eating Disorder

Dasotraline’s pharmacokinetic profile, characterized by an extended half-life, supports its potential for sustained control of moderate-to-severe BED symptoms.

The action date by the FDA under the Prescription Drug User Fee Act (PDUFA) is May 14, 2020.

Dasotraline is an investigational, once-daily medication that demonstrated significant efficacy for the treatment of moderate-to-severe BED in two 12-week, randomized, placebo-controlled studies, SEP360-221 and SEP360-321. Dasotraline was found to be generally well tolerated in clinical studies, including a long-term safety study, SEP360-322, that assessed patients with moderate-to-severe BED for up to one year.

“Binge eating disorder is a serious mental health condition for which limited treatment options exist. The disorder is often seen in association with other behavioral conditions such as depression, substance abuse and post-traumatic stress disorder, and it is often under-diagnosed and under-treated,” said Antony Loebel, M.D., President and Chief Executive Officer at Sunovion. “We are confident in the value dasotraline has shown in clinical trials to people living with BED and look forward to working with the FDA to advance this novel treatment option.”

According to the American Psychiatric Association in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (DSM-5),^2,3 BED is characterized by recurrent and persistent episodes of binge eating, defined as consuming large quantities of food in a short period of time, perception of loss of control during the episode, and intense feelings of shame, guilt and embarrassment afterwards. Many individuals also suffer from depressive and anxiety symptoms, as well as a number of medical complications, leading to impaired functioning and quality of life.⁴

SEP360-221 was a Phase 2/3, 12-week, randomized, double-blind, parallel-group, multi-center, placebo-controlled, flexible-dose study comparing dasotraline with placebo in adults ages 18 to 55 years with moderate-to-severe BED. Dasotraline was administered once-daily in doses ranging from 4 to 8 mg or placebo.

The primary efficacy endpoint was the change from baseline in number of binge days (defined as days during which at least one binge episode occurred) per week at Week 12. Dasotraline was statistically superior to placebo on the primary efficacy endpoint and all key secondary efficacy endpoints: CGI-S, Y-BOCS-BE and percent of subjects with a four-week cessation from binge eating. Dasotraline was generally well tolerated. The most common adverse events were consistent with completed adult dasotraline studies and include insomnia, dry mouth, decreased appetite, anxiety, nausea and decreased weight.

SEP360-321 was a Phase 3, 12-week, randomized, double-blind, parallel-group, multi-center, placebo-controlled, fixed-dose study comparing dasotraline versus placebo in adults 18 to 55 years of age with moderate-to-severe BED. Subjects were randomized to receive fixed, once-daily doses of dasotraline 4 mg, dasotraline 6 mg or placebo.

The study met its primary efficacy endpoint and demonstrated a statistically significant decrease in the number of binge days per week at Week 12 in the group treated with dasotraline 6 mg/day versus the placebo-treated group.

Dasotraline was generally well tolerated in both dose groups. The most common (≥10 percent) adverse events in either dasotraline dose group were insomnia, dry mouth, headache, decreased appetite, nausea and anxiety, consistent with previous dasotraline studies. Following completion of study SEP360-321, patients had the option to enroll in a 12-month, open-label extension study (SEP360-322), evaluating the long-term safety and tolerability of dasotraline for the treatment of BED

Discovered and developed by Sunovion, dasotraline is a new chemical entity that inhibits presynaptic reuptake of dopamine and norepinephrine in the central nervous system (CNS). It does not stimulate neuronal release of dopamine and norepinephrine. Dasotraline is currently being investigated for the treatment of adults 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. The company’s New Drug Application (NDA) for BED is under review with the U.S. Food and Drug Administration (FDA). Sunovion is evaluating other potential indications for dasotraline, including attention-deficit hyperactivity disorder (ADHD). Dasotraline has not been approved by the FDA for any indication.

BED is characterized by recurrent and persistent episodes of binge eating. An episode of binge eating is defined as eating an abnormally large amount of food in a discrete period of time. This is typically accompanied by a sense of lack of control. Binge eating must be characterized by marked distress, and symptoms include: eating more rapidly than normal; eating until feeling uncomfortably full; eating large amounts of food when not feeling physically hungry; eating alone because of embarrassment and feeling disgusted, guilty or depressed afterwards.³ BED is estimated to impact 4.1 million people in the U.S. The lifetime prevalence of BED among adult women and men in the U.S. is 3.6 percent and 2.1 percent, respectively.^5,6

BED typically begins in young adulthood but can also start later.⁷ BED can lead to a number of psychological and physical problems, such as social isolation, feeling bad about oneself, problems functioning at work, obesity and related medical conditions (e.g., gastroesophageal reflux disease, joint problems, heart disease, type 2 diabetes and some sleep-related breathing disorders).⁸ It is also associated with increased healthcare utilization, medical morbidity and mortality.³ While some people with BED are obese, many people with the condition maintain normal body weights.

Source: Company Press Release