Biotech Values

[ariadndndough]

biotech jim safety looks great?? your opinion? no cataplexy was that an issue with the other ones?

Safety Results

Over three months, the overall incidence of AEs reported as related to the medicine in patients who took the high dose of suvorexant compared to placebo was 25.1 percent versus 13.8 percent in Trial 1, and 22.2 percent versus 16.4 percent in Trial 2. The overall incidence of discontinuations due to an AE in patients who received the high dose of suvorexant compared to placebo was 4.7 percent versus 6.0 percent in Trial 1, and 4.7 percent versus 4.4 percent in Trial 2. No serious drug-related AEs were observed in either trial with the high dose of suvorexant. The most common AEs that occurred at an incidence of greater than or equal to five percent and more often than placebo in patients who received the high dose of suvorexant were sleepiness (10.7 percent vs. 3.4 percent with placebo in Trial 1; 10.3 percent vs. 3.1 percent with placebo in Trial 2) and headache (6.8 percent vs. 6.0 percent with placebo in Trial 1; 7.5 percent vs. 5.7 percent with placebo in Trial 2).

In the overall study population, there were no statistically significant next day objective residual effects compared to placebo as measured by the Digit Symbol Substitution Test (an assessment of memory, attention, visual scanning and perceptual and motor speed). Additionally, patients reported incidence of next day sleepiness at three months were 10.7 percent for high dose of suvorexant versus 3.4 percent for placebo in Trial 1, and 10.3 percent versus 3.1 percent in Trial 2. Cataplexy, an abrupt and temporary loss of muscle control, was not reported in either study. Patients with narcolepsy or cataplexy were excluded from these trials.