Cipher Granted Approval of Ozanex in Canada

Cipher Pharmaceuticals (TSX:CPH) received approval from Health Canada for Ozanex (ozenoxacin cream, 1%), an antibiotic treatment of impetigo for patients two months or older.
As quoted in the press release:

“The approval of OZANEX offers a new and effective treatment option for young children suffering with one of the most common and contagious bacterial skin infections,” said Dr. Ian Landells, a Pediatric Dermatologist from St. John’s, Newfoundland. “It’s the first bacteriocidal topical antibiotic and has been shown to be effective against resistant bacteria such as MRSA.”
OZANEX, which belongs to a new generation of non-fluorinated quinolones, offers a short 5-day BID dosing regimen and has shown bacteriological eradication as early as day 3 of treatment.
The Health Canada approval was based on two multicentre, randomized, placebo controlled Phase III studies involving 875 adult and pediatric subjects with impetigo. The results of the clinical program confirmed the efficacy of OZANEX cream on both clinical and bacteriological endpoints. OZANEX cream was shown to be safe and well tolerated in both the adult and pediatric population.

Click here to read the full press release.

Source: www.newswire.ca