|View printer-friendly version|
|May 13, 2014 8:30 a.m.|
|Teva Announces FDA Acceptance of sNDA Filing for Pediatric Indication for QNASL® (Beclomethasone Dipropionate) Nasal Aerosol|
First waterless corticosteroid nasal spray to apply for pediatric approval
“We are very pleased the
The sNDA filing includes data from three double-blind, placebo-controlled studies that evaluated the safety and efficacy of QNASL® in children with allergic rhinitis (AR). The data demonstrated that once-daily treatment with QNASL® provided significant nasal allergy symptom relief in pediatric subjects with SAR and PAR when compared with placebo. In all three studies the safety profile of QNASL® was similar to that of placebo and adverse events were consistent with those seen in previous clinical studies.
“With approximately 10 percent of all children in the U.S. living with
allergic rhinitis, there is a need for new treatment options that can
help children and their caregivers better manage the often bothersome
symptoms of nasal allergies,” said Dr.
QNASL® is a waterless nasal allergy aerosol available only by prescription. When used once a day, QNASL® delivers 24-hour relief of nasal allergy symptoms in patients with different types of nasal allergies, such as indoor, outdoor, seasonal and year round.
About Allergic Rhinitis
Allergic rhinitis is a chronic inflammatory disease characterized by symptoms such as sneezing, nasal itch, runny nose and nasal congestion. For many AR patients, nasal congestion or a stuffy nose may be the most frequent and bothersome symptom. 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.
According to the
About QNASL® (Beclomethasone Dipropionate)
QNASL® (beclomethasone diproprionate) Nasal Aerosol is a prescription corticosteroid medication that treats nasal symptoms associated with seasonal and year-round allergies in adults and adolescents 12 years of age and older. It is administered as a waterless spray delivered by hydrofluoroalkane (HFA), an environmentally friendly propellant. QNASL® contains beclomethasone dipropionate, which is a man-made (synthetic) corticosteroid. Corticosteroids are natural substances found in the body that reduce inflammation. When QNASL® is sprayed into the nose, it helps reduce the nasal symptoms of allergic rhinitis (inflammation of the lining of the nose), such as stuffy nose, runny nose, nasal itching and sneezing.
Important Safety Information
In clinical studies, nosebleeds and nose ulcers were more common in patients treated with QNASL® Nasal Aerosol than patients who received placebo. Some nosebleeds were more severe in patients treated with QNASL® Nasal Aerosol than in patients who received placebo. Tell your healthcare provider if you start to have nosebleeds or nasal ulcers after using QNASL® Nasal Aerosol.
Thrush (Candida), a fungal infection in your nose, mouth, or throat may occur. Tell your healthcare provider if you have any redness or white colored patches in your mouth or throat.
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 experience 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 have immune system problems or use drugs, including corticosteroids, which may weaken the body’s ability to fight infections. Avoid contact with people who have infections like chickenpox or measles while using QNASL® Nasal Aerosol.
Speak to your healthcare provider before using QNASL® Nasal Aerosol if you have tuberculosis or untreated fungal, bacterial, or viral infections, or eye infections caused by herpes. Symptoms of an infection include: fever, pain, aches, chills, feeling tired, nausea and vomiting.
A condition in which the adrenal glands do not make enough steroid hormones may occur. Symptoms can include tiredness, weakness, dizziness, nausea and vomiting. Tell your healthcare provider if you experience these symptoms.
Children taking QNASL® (beclomethasone dipropionate) 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.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all of the possible side effects of QNASL® (beclomethasone dipropionate) Nasal Aerosol. For more information, ask your healthcare provider or pharmacist.
You are encouraged to report negative side effects of prescription drugs
Visit http://qnasl.com/Content/pdf/pi.pdf for full prescribing information.
Safe Harbor Statement under the U.S. Private Securities Litigation Reform Act of 1995:
This release contains forward-looking statements, which 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
develop and commercialize additional pharmaceutical products;
competition for our innovative products, especially COPAXONE®
(including competition from orally-administered alternatives, as well as
from potential purported generic equivalents); the possibility of
material fines, penalties and other sanctions and other adverse
consequences arising out of our ongoing FCPA investigations and related
matters; our ability to achieve expected results from the research and
development efforts invested in our pipeline of specialty and other
products; our ability to reduce operating expenses to the extent and
during the timeframe intended by our cost reduction program; our ability
to identify and successfully bid for suitable acquisition targets or
licensing opportunities, or to consummate and integrate acquisitions;
the extent to which any manufacturing or quality control problems damage
our reputation for quality production and require costly remediation;
our potential exposure to product liability claims that are not covered
by insurance; increased government scrutiny in both the U.S. and
Teva Pharmaceuticals Industries Ltd.