Clinical Pharmacology Review
May 24, 2007
Omnaris™ (ciclesonide) nasal spray
Altana / Nycomed
Type of Submission: Complete Response to NDA Approvable Letter
Partha Roy, Ph.D.
November 7, 2007
Ciclesonide Aqueous Nasal spray received approval for the treatment of the symptoms of
seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) in patients ≥ 12
years of age on October 7, 2006. At the same time, NDA 22-124 for patients under 12
years of age was given an approvable action. The deficiencies cited in the action letter for
NDA 22-124 were inadequate efficacy and safety in this age group.
The purpose of this submission is to provide efficacy and safety data in response to the
deficiencies outlined within the approvable action associated with the use of
OMNARIS™ (ciclesonide) Nasal Spray in children 2 to 11 years of age.
From the clinical pharmacology perspective, there is one new clinical study (M1-416)
where HPA axis function was evaluated in children 2 to 5 years of age suffering from
PAR. For the 6 to 11 year age group, no new HPA axis data are submitted.
HPA axis evaluation in patients 2 to 5 years of age
Study M1-405 was submitted as part of the original NDA 22-004 submission in which
HPA axis evaluation was performed in PAR patients 2 to 5 years of age. Detailed review
can be found in Dr. Sayed Al Habet’s Clinical Pharmacology Review dated August 28,
2006. The study results have been incorporated in the approved Omnaris® label. Briefly,
the differences (95% CI) from placebo in the mean change of 24-hr UFC from baseline
after 6 weeks of treatment were -2.04 (-4.4, 0.3), -1.96 (-4.5, 0.6), and -1.76 (-4.3, 0.8)
mcg/day for 200 mcg, 100 mcg, and 25 mcg dose groups, respectively. The
corresponding differences (95% CI) from p