Thursday, July 15, 2010

More excerpts from FDA briefing document on Qnexa

"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)."

"Six individuals in the placebo group (atypical angina, coronary artery disease, left main coronary disease) and five individuals in the PHEN/TPM group experienced a non-fatal serious adverse event related to cardiac ischemia defined within this subclass. An additional placebo-treated individual died of cardiorespiratory arrest. Coronary artery disease was the most common adverse event within the placebo group and myocardial infarction was the most common adverse event within the PHEN/TPM-treated group."

"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."

These adverse side effects are problematic for Qnexa, in my opinion. We should find out more in today's independent advisory committee review, and the October 28 PDUFA event.

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