STUDY346
MAINTENANCE OF EFFICACY STUDY
Adverse reactions reported by ≥5% of adult patients with moderate to severe B.E.D. taking Vyvanse in a double-blind, placebo-controlled, randomized-withdrawal study.3
Open-label treatment phase (12 weeks)3
ADVERSE REACTIONS |
VYVANSE (n=411) |
---|---|
Dry Mouth | 33.8% |
Headache | 16.1% |
Insomnia | 11.2% |
Decreased Appetite | 9.2% |
Nausea | 8.5% |
Anxiety | 7.1% |
Constipation | 6.8% |
Hyperhidrosis | 5.6% |
Feeling Jittery | 5.1% |
Diarrhea | 5.1% |
Randomized-withdrawal phase (26 weeks)3
ADVERSE REACTIONS |
VYVANSE (n=136) |
PLACEBO (n=134) |
---|---|---|
Nasopharyngitis | 9.6% | 6.7% |
Headache | 8.8% | 6.7% |
Upper Respiratory Tract Infection | 8.1% | 3.7% |
Dry Mouth | 5.1% | 1.5% |
The safety profile of Vyvanse was consistent with what has been reported in previous studies of adults with B.E.D.4
Discontinuation rates3,4:
- During the open-label phase, 5.4% (22/411) of patients discontinued due to adverse reactions
- During the randomized-withdrawal phase, 4.4% (6/136) of Vyvanse-treated patients discontinued due to adverse reactions compared with no placebo patients (0/134)
- -No single adverse reaction was reported for more than 1 patient