Health Canada approves ozenoxacin 1% cream for treating impetigo

Cipher Pharmaceuticals announced that Health Canada has approved Ozanex, a novel topical antibiotic, for the indication of treating impetigo in patients aged 2 months and older.

“The approval of Ozaenex [ozenonoxacin cream, 1%] offers a new and effective treatment option of young children suffering with one of the most common and contagious bacterial skin infections,” Ian Landells, MD, FRCPC, a pediatric dermatologist from St. John’s, Newfoundland, stated in a press release from Cipher. “It’s the first bactericidal topical antibiotic to be shown to be effective against resistant bacteria such as MRSA.”

Ozanex has a 5-day, twice-a-day dosing regimen, with bacteriological eradication shown in as early as after 3 days of treatment, according to the release.

Results of two multicenter, randomized, placebo-controlled phase 3 studies of 875 adults and children with impetigo were the basis of the Health Canada approval. Efficacy of ozenonoxacin cream, 1% was shown in clinical and bacteriological endpoints and was found to be safe and well-tolerated in both adults and children, according to the release.

Reference: www.cipherpharma.com