Teva announces FDA approval of QNASLTM

Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved QNASLTM Nasal Aerosol, a new, “dry” nasal aerosol corticosteroid that treats seasonal nasal and year-round nasal allergy symptoms in adults and adolescents 12 years of age and older. The product is expected to be available by prescription in April 2012 and will be the first marketed nonaqueous or “dry” nasal aerosol in a product category that reports annual sales of $2.5 billion.1 QNASLTM is delivered as a once-daily, pressurized, HFA-propelled nonaqueous aerosol that is environmentally friendly2 and offers a built-in dose counter.

“There are some patients with allergic rhinitis who report dissatisfaction with the currently available therapies,” said Gary N. Gross, MD, FACAAI, practicing allergist and co-founder of the Dallas Asthma and Allergy Center. “The approval of QNASL offers these patients a safe and effective treatment option with a new dry mode of delivery.”

The approval of QNASLTM Nasal Aerosol is based on a comprehensive clinical development program that assessed the product’s safety and efficacy in the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) in adolescent and adult patients 12 years of age and older. The safety and efficacy of QNASLTM Nasal Aerosol was demonstrated in four, Phase III randomized, double-blind, parallel-group, multicenter, placebo-controlled clinical trials. In these trials, patients received QNASLTM 320 mcg once-daily administered as two sprays in each nostril.

Allergic rhinitis (AR) is the most common allergic disease in the U.S., affecting between 10 to 30 percent of adults and adolescents.3 It affects more than one in five people, causing some to have symptoms year round (PAR) and others to experience symptoms during specific times of the year (SAR), such as spring or fall.4

“Given the number of people living with allergic rhinitis who are still seeking adequate relief, the availability of a new dry nasal aerosol is very welcome news,” said Mike Tringale, vice president of external affairs at the Asthma and Allergy Foundation of America (AAFA). “Seasonal and perennial allergies can have a significant impact on a person’s quality of life and we commend Teva for providing patients with a great new option that expands access to quality care.”

While intranasal corticosteroids are recommended as first-line therapy for AR5, the only available options on the market prior to the approval of QNASLTM (beclomethasone dipropionate) were aqueous formulations. Results from a 2010 survey entitled NASAL Allergy Survey Assessing Limitations (NASAL), showed that some nasal allergy patients reported dissatisfaction with their current allergy treatment.6 Healthcare providers and specialists also reported patient dissatisfaction with current nasal sprays.

“The approval of QNASL is a significant milestone for Teva Respiratory and represents our commitment to addressing the unmet needs of millions of Americans suffering from allergic rhinitis,” said Tushar Shah, MD, Senior Vice President, Teva Global Respiratory Research and Development. “We are committed to the development of new options for treatment of respiratory diseases that meet patients’ needs.”

About Allergic Rhinitis

Allergic rhinitis (AR) is a chronic inflammatory disease characterized by symptoms such as sneezing, nasal itch, rhinorrhea, and nasal congestion. For many AR patients, nasal congestion or a stuffy nose may be the most frequent and bothersome symptom.6 According to a recent survey, patients suffer considerable discomfort during allergy attacks, such that nearly two out of five (38 percent) said their discomfort was not tolerable without relief. Based on the available evidence, intranasal corticosteroids are the most effective treatment options for patients with AR. Morbidity associated with AR can be significant. Effective treatment of AR may improve asthma control when both diseases coexist.

In the U.S., the prevalence of AR has increased during the past three decades; it is recently estimated at 20 percent in the general adult and adolescent populations. Of those Americans affected with AR, approximately 20 percent have SAR, 40 percent have PAR, and 40 percent have a combination of the two (i.e., PAR with seasonal exacerbation) depending on the allergen sensitivity. Because of its prevalence and health effect, AR is associated with considerable direct and indirect costs. An estimate of $11.2 billion in healthcare costs, 12 million physician office visits, 2 million days of school absences and 3.5 million lost work days per year are attributed to AR. In addition, the presence of co-morbidities such as asthma and sinusitis further increase AR-related treatment costs.

About QNASLTM (beclomethasone dipropionate)

QNASL Nasal Aerosol is a prescription corticosteroid medication that treats seasonal nasal and year-round nasal allergy symptoms in adults and adolescents 12 years of age and older. It is administered as a nonaqueous or “dry” spray delivered by hydrofluoroalkane (HFA), an environmentally friendly propellant. QNASL Nasal Aerosol contains beclomethasone dipropionate, which is a man-made (synthetic) corticosteroid. Corticosteroids are natural substances found in the body that reduce inflammation. When QNASL Nasal Aerosol is sprayed into the nose, it may help reduce the nasal symptoms of allergic rhinitis (inflammation of the lining of the nose), such as stuffy nose, runny nose, itching, and sneezing. It is not known if QNASL Nasal Aerosol is safe and effective in children under 12 years of age.

Visit www.qnasl.com/pdf/PI.pdf for full prescribing information.

Important Safety Information

You should avoid using QNASL Nasal Aerosol until your nose is healed if you have a sore in your nose, you have had recent surgery on your nose or if your nose has been injured, because QNASL Nasal Aerosol may cause slow wound healing.

Some people who use corticosteroids may have eye problems such as increased pressure in the eye (glaucoma) or cataracts. If you have a history of glaucoma or cataracts or have a family history of eye problems, you should have regular eye exams while you use QNASL Nasal Aerosol.

Serious allergic reactions can happen in people taking QNASL Nasal Aerosol. Stop using QNASL Nasal Aerosol and call your healthcare provider right away or get emergency help if you have shortness of breath or trouble breathing, skin rash, redness, swelling, severe itching, or swelling of your lips, tongue or face.

People are more likely to get infections if they use drugs like corticosteroids that may weaken the body’s ability to fight infections. Avoid contact with people who have infections like chickenpox or measles. Speak to your doctor before using QNASL Nasal Aerosol if you have tuberculosis or untreated infections of any kind.

A condition in which the adrenal glands do not make enough steroid hormones may occur. Symptoms can include tiredness, weakness, dizziness, nausea and vomiting. Speak to your doctor if you experience these symptoms.

Children taking QNASL Nasal Aerosol should have their growth checked regularly, since corticosteroids may slow growth in children.

The most common side effects with QNASL Nasal Aerosol are nasal discomfort, nosebleeds, and headache.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

References

1. Allergic Rhinitis Therapeutics – Pipeline Assessment and Market Forecasts to 2018. Retrieved March 9, 2012, from ©Global Data.20: 2011.
2. The Montreal Protocol on Substances that Deplete the Ozone Layer. Retrieved March 12, 2012, from the United Nations Environment Programme. Available at: http://www.unep.org/ozone/pdf/Montreal-Protocol2000.pdf.
3. Rhinitis (Hay Fever): Tips to Remember. Retrieved February 7, 2012, from American Academy of Allergy Asthma & Immunology. Available at: http://www.aaaai.org/conditions-and-treatments/library/at-a-glance/rhinitis.aspx.
4. Hay Fever. Retrieved February 7, 2012, from the Mayo Clinic. Available at: http://www.mayoclinic.com/health/hay-fever/DS00174.
5. Treatment of Allergic Rhinitis. Retrieved March 12, 2012, from the American Family Physician. 2010 Jun 15;81(12):1440-1446.
6. Nasal Allergy Survey Assessing Limitations (NASAL). Retrieved March 13, 2012, Teva Respiratory. Available at: http://www.nasalsurvey.com/.