Dasotraline is an investigational medication discovered by Sunovion Pharmaceuticals Inc. and is currently under development for the treatment of:
- ADHD (in children) and
- Binge eating disorder (in adults).
⇒⇒ This in not FDA approved yet.
Mechanism of Action:
- Dopamine and Nonepinephrine reuptake inhibitor.
Extended Half Life:
- 47-77 hrs
- taken once daily.
Sunovion Pharmaceuticals Inc. released results of study SEP360-221 and SEP360-321 in July 2019.
SEP360-202, SEP360-212 and SEP360-301 in July, 2019.
Study SEP360-202 (for ADHD):
- Pivotal Phase 2/3 study
- Duration: 6 weeks
- Design: randomized, double blind, multi-center, placebo controlled, parallel-group efficacy study.
- Compared Dasotraline with placebo in children 6-12 yr age with ADHD.
- 342 patients were randomized 1:1:1 = Dasotraline (2 mg/day): Dasotraline (4 mg.day): Placebo.
- Dosing: patient in Dasotraline (4 mg/day) were initiated in 2 mg/day and dose increased to 4 mg/day after 1 week.
Results of Study SEP360-202:
- Dasotraline (4mg/day) > placebo in ADHD symptoms (statistically significant for ADHD rating scale IV and CGI-S.
- This improvement was maintained over week 6.
- Dasotraline (2mg/day) not statistically different from placebo.
- Dasotraline 2mg/day and 4mg/day: well tolerated.
- Most common treatment emergent adverse events: insomnia, decreased appetite, weight loss.
Study SEP360-301 (for Binge Eating Disorder):
- Phase 3 study
- Duration: 8 weeks
- Design: randomized, double blind, multi-center, placebo controlled, fixed dose study.
- Compared Dasotraline 4mg, Dasotraline 6mg and placebo daily.
Results of Study SEP360-301:
- Dasotraline 4 mg daily and 6 mg daily NOT statistically superior to placebo (in primary endpoint). BUT greater improvement noted for 6 mg daily.
- For secondary endpoints: 6mg daily showed statistically significant improvement at week 8.
- Adverse Events: insomnia, headache, dry mouth, decreased appetite and anxiety.
Study SEP360-321 (for Binge Eating Disorder):
- Phase 3 study
- Duration: 12 weeks
- Design: randomized, double-blind, parallel-group, multi-center, placebo-controlled, fixed-dose study.
- Compared dasotraline versus placebo in adults 18 to 55 years of age with moderate-to-severe Binge Eating Disorder.
- randomized to receive fixed, once-daily doses of dasotraline 4 mg, dasotraline 6 mg or placebo.
Results of Study SEP360-321:
- 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.
Abuse Potential of Dasotraline
Less (per clinical studies conducted by Sunovion Pharmaceuticals Inc.):
- Design: Randomized, double-blind, double-dummy, 6-way crossover study
- Dasotraline (8 mg, 16 mg and 36 mg) was compared to placebo and methylphenidate (40 mg and 80 mg; positive controls)
- n= 48 randomized subjects who were healthy adult recreational stimulant users.
- Dasotraline 16 mg and 36 mg doses were included in the study for the purpose of assessing abuse potential. The 36 mg dose is considered supratherapeutic.
- The primary endpoint was the drug liking VAS score at the time of peak effect (Emax), which is a standard measure of abuse liability in human abuse liability studies and is considered one of the most sensitive indices of abuse liability.
- Both doses of methylphenidate were associated with significantly higher VAS-drug liking scores at Emax compared with dasotraline 8 mg (P<0.001), 16 mg (P<0.001) and 36 mg (P<0.01).
- No significant differences between dasotraline (8 mg, 16 mg) and placebo across secondary endpoints.
- Dasotraline 36 mg was associated with statistically significant disliking compared to placebo and methylphenidate, as measured by Overall Drug Liking (Emin) VAS scores.
- Dasotraline 8 mg and 16 mg were generally well-tolerated in this study, with an incidence of adverse events that was similar to placebo, with the exception of a higher incidence of insomnia on the two dasotraline doses and headache on the 16 mg dose.
- Higher incidence of adverse events was observed on dasotraline 36 mg – a dose that is higher than the anticipated maximum therapeutic dose – and on the two doses of methylphenidate.
- Sunovian press release July 30, 2019 (release)
- SEP360-202: A 6-week, Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-group Efficacy and Safety Study of Dasotraline Versus Placebo in Subjects 6 to 12 Years of Age With Attention Deficit Hyperactivity Disorder (Clinical Trials)
- SEP360-321: A 12-week, Randomized, Double-blind, Parallel-group, Placebo-controlled, Fixed-dosed, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Dasotraline in Adults With Moderate to Severe Binge Eating Disorder (clinical trials)
- SEP360-301: A Randomized, Double Blind, Multicenter, Placebo Controlled, Parallel Group, Efficacy and Safety Study of 2 Doses of Dasotraline in Adults With Attention Deficit Hyperactivity Disorder (clinical trials)