NAFDAC approves world’s
first single-dose antibiotic
By WALTER UKAEGBU
Tuesday, March 25, 2008
The National Agency for Food and Drug Administration and
Control (NAFDAC) has approved the first and only single-dose
liquid dosage form antibiotic treatment for certain types
of infections in patients appropriate for oral therapy.
The new drug, Zmax (azithromycin extended release), manufactured
by Pfizer, offers a full course of treatment for mild-to-moderate
sinusitis and pneumonia in a single, high (2 g) dose.
Before now, current antibiotic treatments are taken in multiple
doses over several days. Zmax is thus the first and only single-dose
antibiotic in the world.
The new drug’s microsphere technology allows for delivery
of the entire course of therapy in a single, high (2 g) dose,
while maintaining a favourable side-effect profile. Although
it is taken once, Zmax continues working over time to fight
the infection.
A statement from Pfizer said the new drug will be launched
in Nigeria in April. According to Pfizer’s Medical Director,
Dr. Kodjo Soroh, the introduction of a single-dose antibiotic
would help reduce the problem of non-compliance associated
with the normal multiple doses of antibiotics.
According to him, the chance that a patient will fail to complete
the course of treatment is reduced in Zmax. He disclosed that
100 per cent of Zmax-treated patients completed therapy during
clinical trials.
He said: “Not taking antibiotics as prescribed may lead
to prolonged illness, relapse and the need for re-treatment.
A complete course of antibiotics is needed to kill all the
harmful bacteria.
An incomplete course of antibiotics often wipes out only the
most vulnerable bacteria, which allows relatively resistant
bacteria to survive and thrive. These are some of the problems
that will be resolved with the introduction of Zmax.
“Azithromycin extended release microspheres suspension
offers a safety profile comparable to other antibiotic treatments
for common respiratory tract infections and is generally well
tolerated. In clinical studies, side effects were generally
mild to moderate and resolved within two days for the majority
of patients.”
Zmax is indicated for the treatment of mild-to-moderate acute
bacterial sinusitis (ABS) and community-acquired pneumonia
(CAP) due to susceptible organisms in adults appropriate for
oral therapy. It offers a safety profile comparable to other
antibiotic treatments for certain types of sinusitis and pneumonia
and is generally well tolerated. |
