Naproxen is a NSAID, a longer-acting chemical and pharmacological relative
of ibuprofen. One tablet of Aleve contains 220mg of naproxen sodium
(200mg naproxen equivalent) as compared to the 275mg (250mg naproxen)
found in the Rx brand Anaprox. Recommended dose is one tablet every
8-12 hours, though "with experience, some people may find that two
tablets taken initially followed by one every 12 hours, if necessary,
may give better relief." No more than 3 tablets a day should be taken
without a doctor’s advice.
The sodium salt of naproxen is said to be somewhat more quickly
absorbed than the organic acid, the putative reason (aside from
marketing considerations) why the salt is used when the drug is
promoted as an analgesic and antipyretic. The acid itself has
long been sold as an antiinflammatory under the tradename Naprosyn.
It should be interesting to see how well the drug is received in the
US market and whether the FDA decision to allow OTC sale proves to be
benign. There was a fair amount of concern expressed about a similar
decision concerning ibuprofen back in 1984 when it was made available
for OTC sale. As best I can tell, there wasn’t an undue outbreak of
NSAID-induced GI problems stemming from this decision. However,
naproxen appears to be somewhat more prone than ibuprofen to cause
GI problems.
I seem to recall that the FDA can grant firms exclusive marketing
rights to a preparation which has undergone the transition from
Rx-to-OTC sale for several years even if the patent has already
expired. For example, you didn’t see generic ibuprofen or generic
loperamide in OTC formulations until several years after they were
approved for OTC sale. We can probably expect the same for
naproxen sodium.
–
Steve Dyer
d…@ursa-major.spdcc.com