FDA Approves Avelox (moxifloxacin HCl) for Community-Acquired Pneumonia Due to Penicillin-Resistant Streptococcus Pneumoniae

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.

pneumoniae.

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

hospitalizations.

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

indicated organisms.

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.