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Once-Daily Ofloxacin Otic Solution Approved by FDA, Treatment for Common Ear Infection

MONTVALE, N.J., March 1 /PRNewswire/ -- Daiichi Pharmaceutical Corporation announced today the recent approval by the U.S. Food and Drug Administration (FDA) of a once-daily for seven days dosing regimen of FLOXIN® Otic (ofloxacin otic solution) 0.3%, a topical antibiotic agent for the treatment of Otitis Externa (OE), an infection of the ear canal (also known as "Swimmer's Ear") in patients six months of age and older. The FDA approval for once-daily dosing using FLOXIN Otic for OE was based on a clinical study conducted in both pediatric and adult patient populations. A clinical cure rate of 91 percent was achieved in the once-daily, seven-day treatment of OE infections with FLOXIN Otic.

FLOXIN Otic is the first and only once-daily ototopical antibiotic for OE.

It is the only treatment approved by the FDA for all three of the following ear infections: OE, Acute Otitis Media with Tympanostomy Tubes (AOM-TT), and Chronic Suppurative Otitis Media (CSOM) due to the most common pathogens associated with these infections.

"Daiichi is pleased to offer patients and physicians a once-daily dosing regimen of FLOXIN Otic, a proven safe and effective antibiotic," said Jim Hageman, President and CEO. "This represents another milestone for FLOXIN Otic and is a reflection of Daiichi's commitment and focus to developing innovative and unique therapies. Over six million prescriptions have been dispensed for FLOXIN Otic, which is a tribute to its acceptance by patients and healthcare professionals."

"The approval of once-daily FLOXIN Otic for OE is important news for physicians, patients and caregivers alike," said Harold C. Pillsbury III, MD, FACS, Chair, Department of Otolaryngology Head and Neck Surgery at University of North Carolina at Chapel Hill. "As a highly effective and safe ototopical antibiotic agent, FLOXIN Otic has been a unique tool in the clinician's armamentarium for treating OE infections for many years. The product that I have been comfortable with just got better. The FDA approval means that with a drug that I have used for over five years, I now have a shorter once-daily dosing regimen that may prove more convenient for many OE sufferers."

As an ototopical antibacterial solution, FLOXIN Otic is administered as drops into the ear canal. When an antibiotic is administered directly into the ear, the amount of drug reaching the site of infection may be much greater than when it is given by mouth. As a result, the bacteria causing the infection can be effectively eliminated. Use of a topical antibiotic may help to avoid antibiotic resistance.

The inappropriate use of antibiotics leading to resistant bacteria is one of the most pressing health issues facing this country. Physicians, patients and their caregivers are being encouraged by public health agencies nationwide to use antibiotics appropriately to help reduce opportunities for antibiotic- resistant bacteria to survive and multiply.

Ear infections are the most common reason that children receive antibiotics. It is estimated that five out of every ten children are diagnosed with at least one ear infection by their first birthday, and eight out of ten by their third birthday.(1)

"More than ever, the appropriate use of antibiotic therapy is a top priority for healthcare professionals, especially pediatricians," said Sheldon Kaplan, MD, Professor and Vice-Chairman for Clinical Affairs, Department of Pediatrics at Baylor College of Medicine and Chief, Infectious Disease Service at Texas Children's Hospital in Houston, Texas. "The issue of resistance to antimicrobial treatment is particularly critical for children. They tend to have the highest rates of antibiotic use, in large measure due to the treatment of ear infections."

Developed and marketed by Daiichi Pharmaceutical Corporation, FLOXIN Otic (ofloxacin otic solution) 0.3%, first received FDA approval in 1997. It is currently indicated for OE in patients aged six months and older due to Escherichia coli, Pseudomonas aeruginosa, and Staphylococcus aureus; AOM-TT in patients 1-12 years of age with tympanostomy tubes due to P. aeruginosa, S. aureus, Streptococcus pneumoniae, Moraxella catarrhalis, and Haemophilus influenzae; and CSOM in patients 12 years of age and older with perforated tympanic membranes due to P. aeruginosa, S. aureus, and Proteus mirabilis.

With more than six million prescriptions dispensed in the U.S. to date, FLOXIN Otic is the first drop ever approved by the FDA for use in ear infections where the middle ear is exposed. FLOXIN Otic remains the only ototopical that is FDA approved to treat CSOM, one of the most challenging types of ear infections.

Important Safety Information

The most common reported adverse reactions in three clinical trials (n=799) in OE patients treated once daily with FLOXIN Otic were application- site reaction (0.6%-16.8%), pruritus (1%-1.2%), earache (0.6%-0.8%), dizziness (0.0%-0.6%), and headache (0.2%-0.3%). In two of these clinical studies (n=310), the higher application-site reaction rate resulted from the specific questioning of subjects.

The most common reported adverse reactions in clinical trials in AOM patients with TT and CSOM patients treated twice daily with FLOXIN Otic (n=656) were taste perversion (7%), earache (1%), pruritus (1%), paraesthesia (1%), rash (1%), and dizziness (1%).

FLOXIN Otic is contraindicated in patients with a history of hypersensitivity to ofloxacin, other quinolones, or other ingredients of the medication. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving systemic quinolones. At the first sign of allergic reaction, stop taking the drug. Patients who have not improved after one week of treatment should be evaluated by their healthcare provider.

For full prescribing information on FLOXIN Otic, visit http://www.daiichius.com/ or http://www.floxinotic.com/

Source: Daiichi Pharmaceutical Corporation

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