Biotech Values

[tony111]

VVUS

I was going through the AEs of Qnexa in the briefing document, and I have to say I am shocked the street didn't dump the stock.


"The incidence of depression-related adverse events in the PHEN/TPM clinical trials was 3.4% in the placebo group, 5.0% in the low-dose PHEN/TPM group, 3.8% in the mid-dose PHEN/TPM group, and 7.7% in the high-dose PHEN/TPM group." This was never mentioned in their presentation.

"When assessed as a group, the incidence of
cognitive-related adverse events was 1.7%, 2.0%, 5.6%, and 7.8% in the placebo, low-dose, mid-dose, and high-dose PHEN/TPM groups, respectively. The most common adverse event related to cognitive dysfunction was disturbance in attention.
"
"Approximately 30% of individuals treated with high-dose PHEN/TPM experienced a
serum bicarbonate <21 mEq/L compared to 5.9% of individuals treated with placebo.
"

"A higher proportion of PHEN/TPM-treated individuals experienced a categorical
increase in heart rate compared to placebo treated individuals (>20 bpm: 19.6% high-dose PHEN/TPM versus 11.9% placebo)"


I see in no chance such a drug should be the first line therapy and patients should be very carefully monitored when prescribed.