PEDIAPHARM RECEIVES HEALTH CANADA APPROVAL FOR OTIXAL
Pediapharm Inc. (PDP.V) has received Health Canada's approval of Otixal (ciprofloxacin 0.3 per cent and fluocinolone acetonide 0.025 per cent) otic solution for the treatment of acute otitis media with tympanostomy tubes (AOMT) in pediatric patients (aged six months and older).
Otixal(TM) is the first and only antibiotic and steroid combination ear drop available in single, sterile, preservative-free and unit-dose packaging. Otixal(TM) will be launched in a growing $20 million market1.
Otitis media (middle ear inflammation) is one of the most common early childhood infections in Canada2. In the first 3 years of life, 60% to 70% of children will have experienced at least 1 episode of acute otitis media ("AOM"), and recurrent episodes of AOM are common2. Children that have recurrent AOM may have tympanostomy tubes inserted through a small incision in the eardrum to help facilitate drainage of fluid from the middle ear. Tympanostomy tube insertion is the most common operation performed on children in Canada3.
According to Dr. Peter Spafford, head of the Otolaryngology Division at the University of Saskatchewan and President of the Canadian Society of Otolaryngology - Head and Neck Surgery, "The most common symptom of AOMT for many children is fluid drainage from the ear (otorrhea) and having a new medication to treat those children is more than welcome. Additionally, delivering drops into children's ears is not always easy for parents. Otixal's unique single-use, premeasured dosing helps assure an accurate dose every time. This will certainly help parents to be more compliant with the medication."
"Otixal(TM) represents a great opportunity to introduce innovation in a growing market that has not seen innovation for years" stated Richard Labelle, Pediapharm's Vice-President of Sales and Marketing. He added: "Given its strong medical evidence and unique delivery mode, Otixal(TM) has the potential to significantly improve the quality of life of many young patients who have undergone tympanostomy tube insertion and are suffering from acute otitis media"
"We are very pleased with the approval of Otixal(TM), which represents the second Health Canada approval within six months for us" said Sylvain Chretien President and CEO of Pediapharm. "With our strong infrastructure in place and with our track record in successfully launching drugs, we are very confident in our ability to make Otixal(TM) a success in Canada" concluded Mr. Chretien.
OTIXAL(TM) (ciprofloxacin 0.3 % and fluocinolone acetonide 0.025 %) is indicated for the treatment of acute otitis media with tympanostomy tubes (AOMT) in pediatric patients (aged 6 months and older) due due to Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenzae, Moraxella catarrhalis and Pseudomonas aeruginosa. Two phase 3 multicenter, randomized, double-blind, active-controlled, parallel group trials were conducted to assess the efficacy and safety of OTIXAL(TM) compared to ciprofloxacin otic solution and to fluocinolone acetonide otic solution. In total 662 pediatric patients (aged 6 months to 12 years old) with AOMT were included. In both trials, the OTIXAL(TM) treatment arms showed significantly shorter times to cessation of otorrhea in comparison to both the ciprofloxacin and fluocinolone acetonide alone arms. In Study 1 and Study 2 the median time to cessation of otorrhea in the OTIXAL(TM) group was 3.75 days and 4.94 days, respectively.