Vyvanse lisdexamfetamine: Phase II data

Data from the open-label portion of the U.S. Phase II Study 204 trial in 92 patients showed that Vyvanse as adjunctive treatment to atypical antipsychotics met the primary endpoint of significantly improving modified SANS-18 total scores from baseline to week 10 (mean change of 12.9 points, p<0.0001). Vyvanse also met the secondary endpoints of significantly improving both positive and overall psychiatric symptoms as measured by the PANSS positive subscale (mean change of 1 point, p<0.0001) and the PANSS total score from baseline to week 10 (mean change of 9.8 points, p<0.0001). Of the 23 patients who discontinued the study during the open-label portion, 5 discontinued due to an adverse event. Specifically, 2 discontinuations were due to exacerbation of schizophrenia and 3 were due to involuntary jaw movements, elevated blood pressure or sleepiness.

In the 4-week, double-blind randomized discontinuation portion of the trial in 69 patients, there were no significant differences in negative symptoms between Vyvanse and placebo at week 14, which Shire said indicates no worsening or rebound of symptoms after discontinuing Vyvanse (p=0.21). The most common adverse events included headache, insomnia, decreased appetite, dizziness, dry mouth and diarrhea. ...