JERUSALEM--(BUSINESS WIRE)--
Teva Pharmaceutical Industries Ltd. announced today that additional data
analyzed from the Phase III clinical program for QNASL
(beclomethasone dipropionate)Nasal Aerosol will be presented
at the 2013 Annual Meeting of the American Academy of Allergy, Asthma
and Immunology (AAAAI) in San Antonio, Texas on February 22-26, 2013.
QNASL is a nonaqueous or dry-mist nasal aerosol
corticosteroid that treats seasonal and year-round nasal allergy
symptoms in adults and adolescents 12 years of age and older.
Data will be presented at the meeting regarding the efficacy of QNASL
in treating the symptoms associated with seasonal and perennial allergic
rhinitis (SAR and PAR), including the drugs potential quality of life
benefits and sleep quality improvement. Furthermore, the data also
demonstrated nasal symptom relief in patients with SAR and PAR who
received treatment with QNASL24 hours after dosing.
On March 23, 2012, the U.S. Food and Drug Administration (FDA) approved
QNASL. The product became available by prescription in April
2012, making it the first marketed nonaqueous or dry-mist nasal
aerosol product in a category that reports annual sales of $2.5 billion.
QNASL is delivered as a once-daily, nonaqueous aerosol that
uses an environmentally friendly propellant (HFA) and contains a
built-in dose counter.
These studies are important because the impact of allergic rhinitis on
a patients quality of life is significant. Nasal allergies are often
associated with burdensome symptoms such as nasal congestion, sneezing,
and itchy and runny nose, which may contribute to disrupted sleep and
impaired daytime activities, said Dr. Eli Meltzer, Senior Associate,
Allergy & Asthma Medical and Research Center, A.P.C. and Clinical
Professor, Department of Pediatrics, Division of Allergy and Immunology,
University of California, San Diego. These findings reinforce the
efficacy of QNASL to treat nasal symptoms and to provide
sustained relief from burden of allergic rhinitis.
The following QNASL data will be presented during poster
sessions on Sunday, February 24 from 9:45 10:45 a.m. (CST) in Hall C
(street level) of the Henry B. Gonzalez Convention Center at the AAAAI
Annual Meeting:
The data to be presented at AAAAI further explored the safety and
efficacy of QNASL and demonstrated its ability to benefit
patients suffering from seasonal and year-round nasal allergies, said
Tushar Shah, MD, Senior Vice President, Teva Global Respiratory Research
and Development. Teva Respiratory is committed to offering patients
treatment options that deliver continued relief of bothersome nasal
allergy symptoms and help improve their quality of life.
Allergic rhinitis (AR) 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 American Academy of Allergy, Asthma and Immunology
(AAAAI), the prevalence of AR in the U.S. 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 perennial allergic
rhinitis (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.
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-mist spray delivered by
hydrofluoroalkane (HFA), an environmentally friendly propellant. QNASL
(beclomethasone dipropionate)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 (beclomethasone
dipropionate) Nasal Aerosol 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, itching and sneezing. It is
not known whether QNASL (beclomethasone dipropionate) Nasal
Aerosol is safe and effective in children under 12 years of age.
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 , 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
bodys 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
to the FDA. Visit www.fda.gov/medwatch [1],
or call 1-800-FDA-1088.
Visit http://qnasl.com/Content/pdf/pi.pdf [2]
for full prescribing information.
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) is a leading global
pharmaceutical company, committed to increasing access to high-quality
healthcare by developing, producing and marketing affordable generic
drugs as well as innovative and specialty pharmaceuticals and active
pharmaceutical ingredients. Headquartered in Israel, Teva is the world's
leading generic drug maker, with a global product portfolio of more than
1,000 molecules and a direct presence in about 60 countries. Teva's
branded businesses focus on CNS, oncology, pain, respiratory and women's
health therapeutic areas as well as biologics. Teva currently employs
approximately 46,000 people around the world and reached $20.3 billion
in net revenues in 2012.
130595
Kevin
C. Mannix, 215-591-8912orKristen Frank, 215-591-8908orTomer
Amitai, 972 (3) 926-7656orHadar
Vismunski-Weinberg, 972 (3) 926-7687orDenise
Bradley, 215-591-8974
Source: Teva Pharmaceutical Industries Ltd.
