FDA approves olopatadine (Patanase) nasal spray for allergic rhinitis

June 16, 2008

Alcon Laboratories receives regulatory nod for new allergy spray.

According to Alcon, the FDA approval of olopatadine nasal spray was based on three clinical trials, each two weeks in duration. Patients utilized invivodata's DiaryPRO, a technology that collects real-time data, twice daily to record the frequency and severity of symptoms. Results showed that patients treated with olopatadine demonstrated significantly greater decreases in total nasal symptom scores (a measure of stuffy, itchy, runny nose, and sneezing) compared with placebo spray. The new entity exerts its principal effects via selective inhibition of H1-receptors and its antihistaminic activity has been documented in isolated tissues, animal models, and humans.

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According to the manufacturer, the most common adverse reactions (>1%) include bitter taste (12.8%), epistaxis (3.2%), headache (4.4%), pharyngolaryngeal pain (2.2%), post-nasal drip (1.5%), cough (1.4%), and urinary tract infection (1.2%). Patients should be warned of the potential for epistaxis, nasal ulceration, and nasal septal perforation and should periodically be monitored for signs of adverse effects on the nasal mucosa. In addition, patients should be cautioned that somnolence was reported during clinical trials and could affect occupations requiring complete mental alertness or motor coordination. Simultaneous use with alcohol or other central nervous system depressants should be avoided. The percentage of patients who discontinued using the spray due to an adverse reaction was similar among both the olopatadine- and placebo-treated groups at 3.9% and 3.2%, respectively.

Patients suffer with symptoms every allergy season, which make their lives miserable during those months, Meltzer said. "Patanase offers relief beginning in minutes in a convenient steroid-free nasal spray." According to Alcon, Patanase will be available by the end of May 2008.