The FDA issued a letter to Alcon dated November 13, 2012 regarding a sales aid that the agency says overstates the efficacy of Alcon’s Patanase olopatadine hydrochloride nasal spray. In the four-page letter, the agency cites numerous examples of what it says are overstatements of the product’s onset of action and the duration of relief and then requests that Alcon “immediately cease the dissemination of violative promotional materials for Patanase.”
According to the letter, one of the sales aid’s claims, of “Congestion relief in 30 minutes,” is misleading because data used for approval were based on total nasal symptom score (TNSS), not relief of nasal congestion alone, and “Demonstrating an effect on the composite total nasal symptom score does not represent a clear effect on any individual component of the TNSS.”
The agency also notes that the sales aid claimed that Patanase “is the only nasal antihistamine FDA approved to relieve symptoms in 30 minutes,” but that claim was based on an allergen chamber environmental exposure unit studies that “were pharmacodynamic studies conducted in controlled settings that do not reflect real world situations.”
Read the FDA letter to Alcon.
