On February 9, 2012, the Anesthetic and Analgesic Drug Products Advisory Committee will meet to discuss supplemental new drug application (sNDA) 22395/S-013, QUTENZA (capsaicin 8%) Patch, submitted by NeurogesX (NGSX). We conducted a behavioral analysis of the voters listed on the draft committee roster to provide insight into how this panel might vote based on their past voting records. For more information on how we analyze voting behavior, please read our adcom behavioral analysis.
Of the 13 voting members listed on the draft roster, 4 members have served on 1 or more committees in which the vote was non-unanimous. Non-unanimous votes provide the differential voting patterns that allow us to analyze voter behavior. A summary of the voting records for these 4 individuals is listed in the table below. Please click each name for a detailed voting history.
The average liberal-conservative index for this subgroup is 0.283225. If you expect a close panel vote with a margin closer than 70/30, then based on our logistic regression of past panels with greater than 70/30 splits, we estimate a 6% chance that this panel will vote for approval. Note, this subgroup only represents 4/13 members.
IMPORTANT: This behavioral analysis is secondary to a scientific analysis. A thorough analysis of safety and efficacy should form the cornerstone of any due diligence, as safety and efficacy are the primary concern of the FDA. Please consider this behavioral data as a supplemental factor if the outcome remains unclear after evaluating the safety and efficacy.
(Lack of) Efficacy
Qutenza’s FDA briefing documents are fairly negative, with the director’s memo stating “Therefore, it is essential that, as you evaluate the available efficacy data, analyses and assessments that will be presented to you at this meeting, you do so with due consideration to the importance of maintaining regulatory standards.” A memo from the director was not included in the other two briefing documents for ASTX and AMGN. We believe such a letter was necessary because this panel is inexperienced compared to the other two and the director felt compelled to remind them (specifically the patient and consumer representatives) that post-hoc analyses are not proper evidence for approval.
The FDA stacked this panel with three (!) biostatisticians, two of whom (Fleming and Proschan) are very conservative according to our database. There is no way NGSX’s post-hoc analyses will fly, but if you have the opposite opinion and think the decision could favor approval, we hope this voting record data will be helpful to you.
For an explanation of the table headers, please see the “individual results” section of the methods page.
|Name||Num Votes||Proportion Yes||Proportion No||Proportion Abstain||Num Informative Votes||Num Inverse Yes||Inverse Yes||Num Inverse No||Inverse No||Liberal-Conservative Index||Maverick-Conformist Index|