Astelin(R) Nasal Spray Provided Greater Improvement in Relieving Nasal Allergy Symptoms Than Zyrtec(R)

A new head-to-head, peer-reviewed clinical trial demonstrated that ASTELIN(R) Nasal Spray(R) (azelastine HCl), marketed by MedPointe Pharmaceuticals, provided 25 percent greater reduction in nasal symptoms than top-selling prescription antihistamine Zyrtecпѓ' (cetirizine HCl), marketed by Pfizer Inc. The new data, published in the May 2005 issue of Clinical Therapeutics, also showed that ASTELIN offered significantly greater improvements in allergy patients' quality of life, compared to Zyrtec.

"Patients with chronic allergies are often frustrated with allergy medications that do not work as well as they had hoped," said lead investigator, Jonathan Corren, MD, Allergy Research Foundation, Inc. "This study provided clear evidence that ASTELIN offered patients more relief from nasal symptoms than Zytrec and improved their overall quality of life."

The ACT I study (Azelastine Cetirizine Trial) directly compared the efficacy of ASTELIN versus Zyrtec in patients with moderate-to-severe allergic rhinitis in order to determine which prescription antihistamine was more effective in improving nasal symptoms of seasonal allergic rhinitis. The ACT I study examined the efficacy of ASTELIN or Zyrtec against common allergy symptoms, including runny nose, sneezing, nasal itching and nasal congestion. These symptoms collectively were directly measured as the Total Nasal Symptom Score (TNSS). In the ACT I study, patients experienced improvements in TNSS while taking either Astelin or Zytrec; however, patients taking ASTELIN showed an overall greater improvement in TNSS compared to those taking Zyrtec. The average improvement in TNSS for ASTELIN was 5.56 (29.3%) compared with 4.32 (23.0%) with Zyrtec, which was significant (P = .015).

In the assessment of onset of action over four hours, the TNSS was significantly improved from baseline in both treatment groups 15 minutes after initial administration (P < .001). The difference between ASTELIN and Zyrtec was significant at 60 and 240 minutes (both, P = .040). At no time point during the four-hour observation period did the improvement in TNSS with Zyrtec exceed that with ASTELIN.

Using the Rhinitis Quality of Life Questionnaire (RQLQ), the standard tool of measurement, the ACT I study showed that ASTELIN offered statistically significant improvements (P = 0.049) in quality of life benefits compared with Zyrtec.

"This study once again confirms the efficacy of ASTELIN and reaffirms the benefit of a topically administered antihistamine," said Paul Edick, President of MedPointe Pharmaceuticals.

ACT I Study Design

Conducted during the 2004 fall allergy season at 20 investigational centers in major geographic regions throughout the U.S., the ACT I trial was a two-week, randomized, double-blind study involving 307 patients with moderate-to-severe allergic rhinitis. Participants were males and females 12 years of age and older with a two-year history of seasonal allergic rhinitis and a documented positive allergy skin test during the previous year. Following a one-week placebo lead-in period, patients were randomized to ASTELIN two sprays per nostril twice daily plus placebo tablets or Zyrtec 10-mg tablets once daily plus placebo (saline) nasal spray for the two-week, double-blind treatment period. Patients recorded symptoms twice daily in diary cards during the two-week treatment period.

Both ASTELIN and Zyrtec were well tolerated in the ACT I study. The most common adverse event, or side effect, experienced with ASTELIN was bitter taste (3.3 %). The most common side effect of Zyrtec was drowsiness (2.6%).

Impact of Allergies

Allergic rhinitis is the fifth most prevalent chronic disease in the United States, affecting up to 40 million adults and children each year. Allergic rhinitis costs the nation approximately $5.3 billion in direct and indirect costs (including time lost from work and school) and accounts for about 10,000 absences from school.

Twenty percent of the U.S. population suffers from seasonal allergies, which are caused by pollen, spores, and other allergens. Millions of Americans suffering from seasonal allergies also may be sensitive to environmental triggers such as air pollution, cigarette smoke, and cleaning solutions. It is critical that patients seek proper diagnosis with physicians to determine which type of allergies they suffer from to determine the best treatment options.

Additional Information About ASTELIN

ASTELIN, the only prescription antihistamine approved by the Food and Drug Administration to treat symptoms of seasonal allergic rhinitis and nonallergic vasomotor rhinitis, is the fastest-growing antihistamine in new prescriptions in the past year.

ASTELIN is indicated for the treatment of the symptoms of seasonal allergic rhinitis (in patients 5 years of age and older) and nonallergic vasomotor rhinitis (in patients 12 years of age and older). ASTELIN is well tolerated and relieves the full range of rhinitis symptoms, including difficult-to-treat nasal congestion. The most commonly reported adverse events in seasonal allergic rhinitis and nonallergic vasomotor rhinitis patients 12 years of age and older were bitter taste, headache, somnolence, and nasal burning. The adverse event profile in seasonal allergic rhinitis patients 5 to 11 years of age was similar to that in the adult population.

For additional information and/or full Prescribing Information on ASTELIN, please call 1-800-598-4856 or visit www.astelin.com.

About MedPointe Pharmaceuticals

MedPointe Pharmaceuticals is a privately held, specialty pharmaceutical company located in Somerset, New Jersey. MedPointe specializes in respiratory, allergy, central nervous system, cough-cold, and pediatric products. The company maintains a manufacturing facility in Decatur, Illinois. For more information on MedPointe, visit http://www.medpointepharma.com.

Zyrtec is a registered trademark of Pfizer Inc.