Teva Respiratory Announces Positive Results From Phase III Trial of BDP HFA Nasal Aerosol in Seasonal Allergic Rhinitis
"Dry" Nasal Spray Met Primary and Secondary Endpoints
HORSHAM, Pa., July 28 /PRNewswire/ -- Teva Respiratory today
announced positive results from a Phase III trial evaluating the
efficacy and safety of beclomethasone dipropionate (BDP)
hydrofluoroalkane (HFA) Nasal Aerosol in the treatment of seasonal
allergic rhinitis (SAR). The study met all efficacy endpoints,
demonstrating a statistically significant benefit as compared to
placebo. Furthermore, the safety profile of BDP HFA Nasal Aerosol
was similar to placebo.
"The outcomes of the Phase III SAR trial validate the potential
of BDP HFA as a treatment option for patients trying to manage
their nasal allergies," said Mark Salyer, General Manager of Teva's
Respiratory Division. "The goal of this development program is to
address the unmet clinical need among the 60 million Americans
affected with allergic rhinitis who are looking for a solution that
delivers a 'dry' experience to avoid the 'wet feeling' and
postnasal drip associated with the nasal spray formulations that
are available today."
Currently, the intranasal spray (INS) market is composed only of
aqueous or "wet feeling" products; however, prior to the U.S. Food
and Drug Administration's (FDA) decision to phase out metered dose
inhalers (MDIs) that contain chlorofluorocarbons (CFCs), the nasal
market also included aerosol or "dry formulation" sprays. Teva's
Nasal Aerosol utilizes an HFA propellant. Future studies will
further examine the safety and efficacy profile of this
product.
Based on results from the Phase I study that evaluated the
pharmacokinetics, safety and tolerability of BDP HFA, the systemic
exposure following administration of the treatment (up to 320
mcg/day) was approximately 27 percent of orally inhaled BDP HFA,
which is marketed by Teva as the asthma treatment QVAR®
(beclomethasone dipropionate HFA) Inhalation Aerosol. Based on
these results, the established QVAR® safety data may provide
further supportive evidence for the development of this "dry" nasal
formulation for the treatment of allergic rhinitis.
Study Design and Results
The Phase III SAR trial was designed as a randomized,
double-blind, placebo-controlled, parallel-group, clinical study to
assess the efficacy and safety of BDP HFA Nasal Aerosol in the
treatment of SAR in subjects 12 years of age and older. Over a
two-week treatment period during the Mountain Cedar pollen season,
340 patients at four different sites in the U.S. were randomized to
320 mcg of BDP HFA propellant or placebo as a nasal aerosol daily.
To measure efficacy in comparison to placebo, the study used the
standard reflective Total Nasal Symptom Score (TNSS) for primary
endpoints and instantaneous TNSS and Rhinoconjunctivitis Quality of
Life Questionnaire (RQLQ) for secondary endpoints.
The pivotal trial primary and secondary end points both met
statistical significance with Teva's HFA Nasal Aerosol, which
demonstrated clinical efficacy in patients with SAR versus placebo.
The product was also generally well tolerated and comparable to
placebo. The most common adverse events reported were nasal
discomfort, headache, epistaxis (nosebleed), nausea and urticaria
(hives).
About Allergic Rhinitis
Allergic rhinitis (AR) is a chronic inflammatory disease
characterized by sneezing, nasal itch, rhinorrhea, and nasal
congestion as symptoms, in addition to allergic conjunctivitis in
many subjects. For many AR patients, a stuffy nose may be the most
irritating symptom; however, a recent survey reported almost half
(46%) of parents of children with allergic rhinitis reported severe
symptoms such as headache and ear and facial pain. Based on the
available evidence, intranasal corticosteroids are the most
effective treatment options for patients with AR. While AR itself
is not life-threatening (unless accompanied by severe asthma or
anaphylaxis), morbidity associated with the condition can be
significant. The presence of AR commonly exacerbates asthma, and
may increase the risk of asthma attacks, emergency visits and
hospitalizations.
In the U.S., the prevalence of AR has increased during the past
three decades; it is recently estimated at 20% in the general adult
population and closer to 40% in children. Of the estimated 60
million Americans affected with AR, approximately 20% have SAR, 40%
have perennial allergic rhinitis (PAR), and 40% 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 $2.7 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 QVAR®
QVAR® is indicated in the maintenance treatment of asthma as
prophylactic therapy in patients 5 years of age or older. QVAR®
is also indicated for asthma patients who require systemic
corticosteroid administration, where adding QVAR® may reduce or
eliminate the need for systemic corticosteroids.
Important Safety Information
QVAR® is not a bronchodilator and is not indicated for
relief of acute bronchospasm. Common side effects associated with
the use of QVAR® and placebo in clinical trials include, but
are not limited to, headache (12% and 9%, respectively) and
pharyngitis (8% and 4%, respectively). Caution: Adrenal
insufficiency may occur when transferring patients from systemic
steroids (see WARNINGS, Prescribing Information). A reduction in
growth velocity in growing children and teenagers may occur as a
result of inadequate control of chronic diseases such as asthma or
from use of corticosteroids for treatment.
For full Prescribing Information, please click here: http://www.qvar.com/Document/PrescribingInformation.pdf.
About Teva Respiratory
Teva Respiratory is the U.S.-based respiratory subsidiary of
Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA) Teva Pharmaceutical Industries
Ltd., headquartered in Israel, is among the top 15 pharmaceutical
companies in the world and is the leading generic pharmaceutical
company. The company develops, manufactures and markets generic and
innovative pharmaceuticals and active pharmaceutical ingredients.
Over 80 percent of Teva's sales are in North America and Western
Europe.
Teva's Safe Harbor Statement under the U. S. Private Securities
Litigation Reform Act of 1995: 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 versions of Neurontin®, Lotrel® and
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,
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 complex Medicare and
Medicaid reporting and payment obligations, our exposure to
currency fluctuations and restrictions as well as credit risks, the
effects of reforms in healthcare regulation, adverse effects of
political or economical instability, major hostilities or acts of
terrorism on our significant worldwide operations, increased
government scrutiny in both the U.S. and Europe of our agreements
with brand companies, dependence on the effectiveness of our
patents and other protections for innovative products, our ability
to achieve expected results through our innovative R&D efforts,
the difficulty of predicting U.S. Food and Drug Administration,
European Medicines Agency and other regulatory authority approvals,
uncertainties surrounding the legislative and regulatory pathway
for the registration and approval of biotechnology-based products,
potentially significant impairments of intangible assets and
goodwill, potential increases in tax liabilities resulting from
challenges to our intercompany arrangements, our potential exposure
to product liability claims to the extent not covered by insurance,
the termination or expiration of governmental programs or tax
benefits, current economic conditions, any failure to retain key
personnel or to attract additional executive and managerial talent,
environmental risks and other factors that are discussed in this
report and in our other filings with the U.S. Securities and
Exchange Commission ("SEC").
101567
Source: Teva Respiratory, a subsidiary of Teva Pharmaceutical Industries Ltd.
CONTACT: Denise Bradley, +1-215-591-8974, denise.bradley@tevausa.com
Posted: July 2010
