SAN FRANCISCO — A norepinephrine-dopamine reuptake inhibitor (NDRI) that is in phase 3 development showed promise in changing eating behaviors in adult patients with binge eating disorder (BED) in a new study.
There's a real need for additional treatment choices for patients with BED, lead study author Joyce Tsai, PhD, senior director of clinical development in psychiatry, Sunovion Pharmaceuticals Inc, told Medscape Medical News.
"The mainstay of binge eating disorders for many years has been cognitive-behavioral therapy, but there has been an increased recognition that medications have a role to play, especially as many patients don't have access to quality cognitive-behavioral therapy," she said.
The findings were presented here at the American Psychiatric Association (APA) 2019 annual meeting.
BED is a common eating disorder — more people suffer from it than from anorexia and bulimia combined. Yet the condition was not formally recognized until the DSM-5 was developed, said Tsai.
The new 12-week, fixed-dose study included 485 BED patients aged 18–55 years, most of whom were overweight or obese. The patients were required to have experienced three binge days a week at baseline and at least 2 binge days per week during the previous 6 months.
For the study, a binge day was a day in which at least one binge episode occurred. Such an episode involves not only eating too much food but also feeling loss of control. "It isn't just overeating," said Tsai.
She added that binge eating is usually accompanied by feelings of guilt and shame.
Study participants received either oral placebo or dasotraline at a dose of 4 mg or 6 mg daily.
The primary efficacy endpoint was change in the number of binge-eating days per week at 12 weeks. The study found that for this outcome, the 6-mg dose was statistically significantly superior to placebo (–3.47 vs –2.92; P = .0045).
"We also saw some strong trends to efficacy in the 4-mg group," said Tsai. "It was positive from week 1 out to week 8, but then we did not have statistical separation at the last two time points."
Improvements in secondary efficacy measures generally favored dasotraline. For example, change in scores on the Binge Eating Clinical Global Impression of Severity Scale for the patients who received the 6-mg dose of dasotraline was –2.27, compared to 1.77 for the patients who received placebo (P < .01). For patients who received the 4-mg dose, the change was –2.13, vs 1.77 for the patients who received placebo (P < .05).
On the Yale-Brown Obsessive-Compulsive Scale Modified for Binge Eating, the changes in score compared to placebo were as follows: –15.2 vs –11.8 (P < .01) for the 6-mg dose, and –14.1 vs –11.8 (P < .05) for the 4-mg dose.
As for adverse events (AEs), some patients who took dasotraline experienced anxiety, "not unlike with bupropion" (multiple brands), another NDRI, said Tsai.
Other AEs that occurred in patients who took the drug included insomnia, dry mouth, headache, nausea, decreased appetite, and weight loss.
In addition, some patients experienced psychosis, likely owing to an increase in dopamine.
"The psychosis was varied; in some cases, the patient thought they saw something that wasn't there or heard something that wasn't there," said Tsai.
Although some patients discontinued the drug because of psychosis, "most people stayed in the study even with an event," said Tsai. She added that patients in the study could not take an antipsychotic.
Tsai noted that an advantage of dasotraline is its very long half-life, which should eliminate the need for a controlled-release formulation. "Based on the pharmacokinetic profile, we anticipate that you should be able to get 24/7 coverage," she said.
BED is associated with obesity (body mass index ≥30) in up to 45% of patients. Another study that was discussed at the APA meeting compared dasotraline with placebo with regard to change in body weight among 317 patients with BED.
That study found that among obese patients who completed 12 weeks of treatment, about 40% experienced a weight reduction of 5%.
A previous study found that dasotraline did not differ significantly from placebo with respect to the potential for abuse.
In 2015, the stimulant lisdexamfetamine (Vivanse, Shire) was the first drug to be approved by the US Food and Drug Administration for the treatment of moderate or severe BED in adults. The drug is also prescribed for attention-deficit/hyperactivity disorder (ADHD).
Limited Abuse Potential
Commenting on the research for Medscape Medical News, Debra Safer, MD, co-director of the Stanford Adult Eating and Weight Disorders Program, Stanford University, California, said there are advantages to having a BED drug that's not a stimulant or a Schedule 2 controlled drug.
ADHD medications such as lisdexamfetamine can be effective for BED, but some patients are inappropriate candidates for treatment with this and other stimulants, either because of a history of abuse or addiction or because of cardiovascular concerns, she noted.
Dasotraline may be effective for BED patients who also have anxiety or depression, said Safer. Evidence that the new agent might have relatively little abuse potential "is very important," she said.
However, she added, the risk for psychosis with this new agent would be something to consider. An additional concern with all drugs currently available for the treatment of BED has been relapse after patients stop taking them.
Such choices include drugs prescribed for ADHD. Safer noted the "overlap" between ADHD and BED.
"People with ADHD tend to binge eat, and people who binge eat tend to have ADHD in higher than normal numbers," she said.
Safer added that it's important to provide more choices for the treatment of BED.
"Having another drug that is effective but does not have the negative side effects of stimulants would give us another tool in our armamentarium," she said.
An effective intervention that doesn't have side effects is psychotherapy. But Safer agreed that this approach is expensive, time consuming, and that not all patients have access to it.
The study was sponsored by Sunovion Pharma. Tsai is an employee of Sunovion. Safer receives royalties from Guilford Press for books about the use of psychotherapy for BED.
American Psychiatric Association (APA) 2019: Abstract P7-90. Presented May 21, 2019.
Medscape Medical News © 2019
Cite this: Novel Medication May Help Binge Eating Disorder - Medscape - May 29, 2019.