Clinical Pharmacology Review
NDA:
22-124
Submission Date:
May 24, 2007
Name:
Omnaris™ (ciclesonide) nasal spray
Sponsor:
Altana / Nycomed
Type of Submission: Complete Response to NDA Approvable Letter
Reviewer:
Partha Roy, Ph.D.
Date:
November 7, 2007
Background:
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.
Submission:
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.
Review:
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