West Haven, Conn. - The Food and Drug Administration
(FDA) has approved a supplemental new drug application for Avelox
(moxifloxacin HCl) Tablets/I.V. as a treatment for community-acquired
pneumonia (CAP) due to penicillin-resistant Streptococcus pneumoniae (PRSP).
"Avelox, a highly active agent in the fluoroquinolone class, is now an
important option in treating penicillin-resistant S. pneumoniae," said Dr.
Shurjeel Choudhri, director of and senior clinical research physician for Bayer
Pharmaceuticals Corporation. "A key principal of proper antibiotic use is
choosing an agent with excellent activity which may help reduce the
development of resistance and maintain efficacy. Avelox has been shown in
clinical studies to demonstrate high activity in vitro and excellent
clinical success against S. pneumoniae -- important because this organism's
resistance is a worldwide public health concern."
Data provided to the FDA showed that Avelox therapy was effective in each of
the 21 cases of pneumonia caused by penicillin-resistant Streptococcus
pneumoniae. The clinical and bacteriological efficacy of Avelox in the
treatment of Streptococcus pneumoniae was evaluated in nine clinical
studies, which totaled 244 Avelox treated patients with CAP due to S.
About 25 to 35 percent of S. pneumoniae isolates in the United States are
currently resistant or intermediately resistant to penicillin, according to
the IDSA. The National Institutes of Health (NIH) estimate there are
approximately four million cases of community-acquired pneumonia in the
United States each year, and according to the Centers for Disease Control
and Prevention (CDC) Streptococcus pneumoniae infections cause up to 135,000
Avelox has demonstrated excellent antibacterial effect on all major
bacterial causes of respiratory tract infection. The agent was first
approved in 1999 in both Europe and the United States. To date, there have
been nearly 17 million Avelox patient uses for its various indications in
more than 80 countries worldwide.
Avelox (moxifloxacin HCl) Tablets and I.V. are indicated for acute
bacterial exacerbation of chronic bronchitis (ABECB), acute bacterial
sinusitis, community-acquired pneumonia (CAP), and uncomplicated skin and
skin structure infections (uSSSI), caused by susceptible strains of
Avelox is a prescription medication that is generally well tolerated. The
most common side effects, which are usually mild, include nausea, diarrhea,
and dizziness. Patients should be careful about driving or operating machinery
until they are sure Avelox is not causing dizziness. Patients should not take Avelox if they have ever had an allergic reaction to Avelox or any of the other group of antibiotics known as "quinolones," such as ciprofloxacin or levofloxacin. They should avoid taking Avelox if they have been diagnosed with an abnormal heartbeat such as an arrhythmia or are using certain medications used to treat an abnormal heartbeat. These include
quinidine, procainamide, amiodarone and sotalol.