Industry Briefs

FDA Approves Strattera Generic for ADHD

The Food and Drug Administration has approved the first generic versions of Strattera (atomoxetine) for treating attention-deficit/hyperactivity disorder (ADHD) in pediatric and adult patients, the agency announced Tuesday.

Eli Lilly’s Strattera is the only approved drug to treat ADHD that is not a stimulant. Apotex Inc., Teva Pharmaceuticals USA Inc., Aurobindo Pharma Limited, and Glenmark Pharmaceuticals Limited all received the FDA’s go-ahead to market the medication in multiple strengths.

In the clinical trials for atomoxetine in children and adolescents, the most common side effects reported were upset stomach, decreased appetite, nausea, vomiting, dizziness, fatigue, and mood swings. In the clinical trials in adults, the most common side effects reported were constipation, dry mouth, nausea, decreased appetite, dizziness, sexual side effects, and problems passing urine.

Sunovion’s ADHD Candidate Shows Promise in Patients With Binge Eating Disorder

Sunovion Pharmaceuticals in May announced positive findings from a Phase 2/3 study testing the safety and efficacy of dasotraline in adults with moderate to severe binge eating disorder (BED). Dasotraline, a dopamine and norepinephrine reuptake inhibitor, is a novel drug candidate also being evaluated for attention-deficit/hyperactivity disorder.

This 12-week study involved 317 adults aged 18 to 55 with moderate to severe BED who were randomized to receive 4 to 8 mg of dasotraline or placebo once daily. At the end of the study, the participants taking dasotraline showed significant reductions in the frequency of binge eating days per week compared with placebo. In the dasotraline group, 46.5 percent of participants achieved at least four consecutive weeks of binge eating cessation compared with 20.6 percent in the placebo group.

Dasotraline was also superior to placebo on secondary behavioral outcomes, including Clinical Global Impression of Severity of Illness Scale (CGI-S) scores and Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) scores.

The drug was well tolerated overall; the most common side effects were insomnia, dry mouth, decreased appetite, anxiety, nausea, headache, decreased weight, dizziness, irritability, diarrhea, dyspepsia, constipation, and thirst. ■