Patanase (olopatadine hydrochloride)
Company: Alcon
Approval Status: Approved April 2008
Treatment for: seasonal allergic rhinitis
Areas: Otolaryngology; Pediatrics/Neonatology; Pulmonary/Respiratory Diseases
| General Information | Clinical Results | Side Effects | Mechanism of Action | Literature References | Additional Information |
General Information
Patanase is an antihistamine with selective H1 -receptor antagonist activity: its principal effects are mediated via inhibition of H1 receptors.
Patanase is specifically indicated for the relief of the symptoms of seasonal allergic rhinitis in patients 12 years of age and older.
Patanase is supplied as a metered-dose manual spray pump designed for intranasal administration. The recommended initial dose of the drug is two sprays per nostril twice daily. Patanase must be primed before initial use and when it has not been used for more than 7 days.
Clinical Results
FDA Approval
FDA approval of Patanase was based on the results of three clinical
trials. These randomized, double blind, parallel group,
multicenter, placebo (vehicle nasal spray)-controlled clinical
trials 1,598 subjects, aged 12 years and older, in the United
States. The subjects received Patanase Nasal Spray 0.6%, Patanase
Nasal Spray 0.4%, or vehicle nasal spray, two sprays per nostril,
twice-daily. The duration of the study was two weeks. Efficacy was
based on patient recording of 4 individual nasal symptoms (nasal
congestion, rhinorrhea, itchy nose, and sneezing) on a 0 to 3
categorical severity scale (0 = absent, 3 = severe) as reflective
or instantaneous scores. Reflective scoring recorded symptom
severity over the previous 12 hours; instantaneous scoring recorded
symptom severity at the time of recording. The primary efficacy
endpoint was the difference from placebo in the percent change from
baseline in the sum of morning and evening reflective total nasal
symptom score (rTNSS) at the end of the treatment period. In all
studies Patanase exhibited statistically significantly greater
decreases in rTNSS compared to vehicle nasal spray. Study
One: In the Patanase 0.6% and 0.4% groups, the change from
baseline was -3.63 and -3.38, respectively, compared to -2.67 for
the placebo group (p <0.0001 for the high dose group).
Study Two: In the Patanase 0.6% and 0.4% groups,
the change from baseline was -2.90 and -2.63, respectively,
compared to -1.92 in the placebo group (p<0.0001 for the high
dose group).
Onset of action was evaluated in three environmental exposure unit studies. In these studies, subjects with seasonal allergic rhinitis were exposed to high levels of pollen in an environmental exposure unit and then treated with either Patanase Nasal Spray or vehicle nasal spray, two sprays in each nostril. Afterwards they self-reported their allergy symptoms hourly as instantaneous scores for the subsequent 12 hours. Patanase 0.6% was found to have an onset of action of 30 minutes after dosing in the environmental exposure unit and a twelve hour duration of effect.
Ongoing Study Commitments
- Alcon has agreed to a deferred pediatric study under PREA for
the treatment of allergic rhinitis in pediatric patients ages 2 to
11 years of age.
Final Report Submission: July 1, 2009 - Alcon has agreed to conduct a one-year, controlled clinical
trial in patients with perennial allergic rhinitis to assess the
long term safety of povidone-free olopatadine hydrochloride nasal
spray with respect to nasal septal perforation. The FDA also
requested Alcon assess the long term safety of this product with
respect to local nasal adverse effects, including epistaxis and
nasal ulceration, as well as systemic effects. Include at least the
following three treatment groups: povidone-free olopatadine
hydrochloride nasal spray, vehicle placebo with pH matching
olopatadine hydrochloride nasal spray, and vehicle placebo with
normal pH to evaluate if the low pH of the formulation has an
effect on local nasal safety. They were to submit a labeling
supplement reflecting the results of the clinical trial.
Protocol Submission: July 2008
Trial Start Date: November 2008
Final Report Submission: November 2012
Side Effects
Adverse reactions associated with the use of Patanase may include, but are not limited to, the following:
- Bitter taste
- Headache
- Epistaxis
- Pharyngolaryngeal Pain
- Post-nasal drip
- Cough
- Urinary tract infection
Mechanism of Action
Patanase is an antihistamine with selective H1 -receptor antagonist activity: its principal effects are mediated via inhibition of H1 receptors. These drugs selectively bind to but do not activate histamine H1 receptors, thereby blocking the actions of endogenous histamine. They act in the bronchi, capillaries, and other smooth muscles. Histamine acts as a pro-inflammatory signal released from mast cells in response to allergic reactions or tissue damage.
Literature References
Takahashi H, Zhang Y, Morita E Evaluation of the antihistamine effects of olopatadine, cetirizine and fexofenadine during a 24 h period: a double-blind, randomized, crossover, placebo-controlled comparison in skin responses induced by histamine iontophoresis. Archives of Dermatological Research 2008 Feb 28
Fairchild CJ, Meltzer EO, Roland PS, Wells D, Drake M, Wall GM Comprehensive report of the efficacy, safety, quality of life, and work impact of Olopatadine 0.6% and Olopatadine 0.4% treatment in patients with seasonal allergic rhinitis. Allergy and asthma proceedings : the official journal of regional and state allergy societies 2007 Nov-Dec;28(6):716-23
Patel P, Roland PS, Marple BF, Benninger PJ, Margalias H, Brubaker M, Beezley SF, Drake M, Potts SL, Wall GM. An assessment of the onset and duration of action of olopatadine nasal spray. Otolaryngology and head and neck surgery 2007 Dec;137(6):918-24
Hampel FC Jr, Ratner PH, Amar NJ, van Bavel JH, Mohar D, Fairchild CJ, Wall GM, Brubaker MJ, Drake M, Crenshaw KM Improved quality of life among seasonal allergic rhinitis patients treated with olopatadine HCl nasal spray 0.4% and olopatadine HCl nasal spray 0.6% compared with vehicle placebo.Allergy and asthma proceedings : the official journal of regional and state allergy societies. 2006 May-Jun;27(3):202-7
Abelson MB, Gomes PJ, Vogelson CT, Pasquine TA, Gross RD, Turner FD, Wells DT, Bergamini MV, Robertson SM Clinical efficacy of olopatadine hydrochloride ophthalmic solution 0.2% compared with placebo in patients with allergic conjunctivitis or rhinoconjunctivitis: a randomized, double-masked environmental study. Clinical Therapeutics 2004 Aug;26(8):1237-48
Ohmori K, Hayashi K, Kaise T, Ohshima E, Kobayashi S, Yamazaki T, Mukouyama A Pharmacological, pharmacokinetic and clinical properties of olopatadine hydrochloride, a new antiallergic drug. Japanese Journal of Pharmacology 2002 Apr;88(4):379-97
Additional Information
For additional information regarding Patanase or seasonal allergic rhinitis, please visit the Patanase web page.
The FDA drug information shown here is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.
