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Does this data
suggest that Drug S will be a useful additive to morphine?
You
answered:
 | No,
this data
does not suggest that Drug S will be a useful additive
to morphine.
|
INCORRECT
The
unanswered question is whether one could get the same enhancement
of analgesic with equal or less sedation by giving a higher
dose of morphine alone. The addition of a higher morphine
dose would convert this to the type of relative potency
design discussed above.
The
study design illustrated in Figure
6.5, a 2x2 factorial, actually satisfies the requirements
for an analgesic combination as specified in the 1992 FDA
analgesic development guidelines (http://www.fda.gov/cder/guidance/old041fn.pdf),
and drug companies have frequently carried out such 2x2
factorial studies. However, the guidelines intended this
design to be used for combinations of opioids with anti-inflammatory
drugs, whose central nervous system side effects are minimal.
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