Replies to post #98800 on Biotech Values

[biomaven0]

For most people in the trial any cognitive effects were subtle - my guess is that most people might not even notice them.

In an independent analysis commissioned by the applicant, an effect size of 0.5 was used as the minimum threshold for a clinically relevant change. Applying this measure, the four-week effect size of 0.42 on the Total Index Score for the high-dose PHEN/TPM would be considered borderline. Only the Attention index crossed this threshold at 0.58 and 0.66 in the mid- and high-doses, respectively at Week 4 and for the high-dose at 0.7 at Week 28.

They also do a breakdown of the number of people that have more significant effects (defined as a decrement of > 1.5 standard deviations). That was 0% for the low dose, 5% for the high dose.

Cognitive effects from Topamax resolve pretty much immediately on cessation of the drug.

There really was no discernible depression signal here at all. Low dose was better than placebo, high dose the same. Phen/fen had serotonergic effects, so a depression link is at least plausible.

Note that I'm not claiming approval is a slam dunk here - my feeling is that it's in the 60-70% range. Any approval would come with a REMS program and substantial Phase IV requirements.

Peter