Trevena Inc (TRVN)

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iwfal Member Level Tuesday, 02/21/17 11:57:27 PM
Re: biotech jim post# 209253
Post #
209309
of 209318 Go
TRVN - Notes from the telecon and slides:

a) The composite respiratory endpoint ("Respiratory Safety Burden" = incidence of respiratory depression x average duration) was very well behaved wrt dose. For one of the trials they actually noted that p=0.07 for the 0.35 dose (they noted it because there is something odd in the bar chart in that the error bars for 0.35 and morphine do not overlap - begging the question as to why it isn't stat sig. My *guess* is that this is an artifact of some odd statistical gatekeeping methodology (i.e. controlling for multiple endpoints)?)

b) For Upper GI issues (anti-emetic use, vomiting, nausea) one of the trials was stat sig better vomiting for 0.35 (while still using less anti-emetic) and the other was vice versa. So there is a good case that the rate of upper GI issues is around 1/2 the morphine rate at dose of 0.35mg.

c) They noted that they intend to use the results to determine cost - but guessed it to be in the range of $60-$140 per day. (My comment is that is, to my surprise, not all that different from PCA morphine costs, which is, per the following cite, around $40 to $60 per day - see https://www.dovepress.com/cost-of-opioid-intravenous-patient-controlled-analgesia-results-from-a-peer-reviewed-fulltext-article-CEOR. Further, interestingly, the paper gives an added cost of an additional $400 for PCA errors and AE.)

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iwfal Member Level Tuesday, 02/21/17 08:26:25 AM
Re: biotech jim post# 209253
Post #
209254
of 209318 Go
TRVN
Quote:
Incomplete separation on the side effects of respiratory depression markers and nausea and vomiting, in both IV Ph 3 trials.


The problem with the PR is that it is silent on the numbers that will likely matter to the label. E.g. If the trend in nausea/vomiting or resp safety burden is strong in both arms at 0.35 dose they may still get the label. That said, clearly the effect is weaker than in the Ph2 and they will have the Recothrom problem (as Dew refers to it).

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