This long sought-after result was achieved through the use of a common medication, the antihistamine clemastine fumarate
, in the preliminary study presented in April to the American Academy of Neurology's annual meeting in Vancouver, Canada.
A Allergists generally recommend that older adults avoid first-generation antihistamines such as diphenhydramine (Benadryl), chlorpheniramine (Chlor-Trimeton), dimenhydrinate (Dramamine), brompheniramine (Dimetapp and others), clemastine fumarate
(Tavist, Allerhist), and dexbrompheniramine (Drixoral).
A combination he turns to frequently with good success is a standard sedating antihistamine such as clemastine fumarate
(Tavist) at 1.
The new entry is the only O-T-C remedy to combine the anti-histamine clemastine fumarate
with a nasal decongestant, pseudoephedrine hydrochloride, and a pain reliever.
Both relieve such symptoms as sneezing, runny nose and itchy or watery eyes and feature clemastine fumarate, the first new antihistamine offered in the nasal congestion/sinus segment in several years, according to the company.
Unlike other 12-hour O-T-C medicines, clemastine fumarate is not a time-release formula," says a spokesman for the company.
The company's lingual spray formulation of clemastine fumarate, the active ingredient in Tavist(R)(a), is being developed for the rapid treatment of hay fever symptoms.
The company's clemastine fumarate lingual spray is expected to be one-half of the OTC dose, or 0.
The FDA decision results from well-controlled clinical studies of the antihistamine clemastine fumarate, the active ingredient that differentiates the Tavist products from others.
After reviewing the findings of two well-controlled clinical studies plus several supporting studies, in November 1995 an FDA Advisory Panel unanimously recommended that the Tavist products, with the antihistamine clemastine fumarate, be recognized by the FDA as effective in treating cold symptoms, including sneezing and runny nose.
Currently, the only major brand which contains the ingredient clemastine fumarate is Tavist-D and Tavist-1.
Results showed the clemastine fumarate reduced runny noses and sneezing by up to 50 percent over the study group using the placebo.