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|March 26, 2012|
|Teva Announces FDA Approval of QNASLTM (beclomethasone dipropionate), a New Nonaqueous Nasal Aerosol, for the Treatment of Allergic Rhinitis|
New Treatment with “Dry” Mode of Delivery Seeks to Address Unmet Needs of Seasonal and Perennial Allergy Sufferers
“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
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
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
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
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
Teva's Safe Harbor Statement under the
This release contains forward-looking statements, which express the
current beliefs and expectations of management. Such statements are
based on management's current beliefs and expectations and involve a
number of known and unknown risks and uncertainties that could cause our
future results, performance or achievements to differ significantly from
the results, performance or achievements expressed or implied by such
forward-looking statements. Important factors that could cause or
contribute to such differences include risks relating to: our ability to
successfully develop and commercialize additional pharmaceutical
products, the introduction of competing generic equivalents, the extent
to which we may obtain U.S. market exclusivity for certain of our new
generic products and regulatory changes that may prevent us from
utilizing exclusivity periods, potential liability for sales of generic
products prior to a final resolution of outstanding patent litigation,
including that relating to the generic version of Protonix® the extent
to which any manufacturing or quality control problems damage our
reputation for high quality production, the effects of competition on
sales of our innovative products, especially Copaxone® (including
potential generic and oral competition for Copaxone®, the impact of
continuing consolidation of our distributors and customers, our ability
to identify, consummate and successfully integrate acquisitions
(including the acquisition of Cephalon), interruptions in our supply
chain or problems with our information technology systems that adversely
affect our complex manufacturing processes, intense competition in our
specialty pharmaceutical businesses, any failures to comply with the
1 Allergic Rhinitis Therapeutics – Pipeline Assessment and
Market Forecasts to 2018. Retrieved
2 The Montreal Protocol on Substances that Deplete the Ozone
3 Rhinitis (Hay Fever): Tips to Remember. Retrieved
4 Hay Fever. Retrieved
5 Treatment of Allergic Rhinitis. Retrieved
6 Nasal Allergy Survey Assessing Limitations (NASAL).
Teva Pharmaceutical Industries Ltd.