Replies to post #98230 on Biotech Values

[tony111]

Phen is not safe. You need to sign a wavier form or else your doctor most likely will not prescribe it to you. Topomax was dropped by JNJ for the obesity indication due to safety concerns (mental dullness and tingling in fingers). The drop out rate of Qnexa due to adverse events far exceeds placebo. Not to remind you these are patients who went through 1 month of titration period and find it tolerable enough to continue. Also patients with high blood pressure were excluded from the trial as well due to the phen composition. If I recall correctly 15-20% of patients experienced insomnia, dry mouth, paresthesia, altered tastes, and constipation. Again, this is after the titration period. I wonder what the data would look like if the patients who dropped out during titration period were included in their final analysis.

[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.