YARDLEY, Pa., Sept. 29, 2020 /PRNewswire/
-- Optinose (NASDAQ:OPTN), a pharmaceutical company
focused on patients treated by ear, nose and throat (ENT) and
allergy specialists, today announced the peer-review publication of
a paper titled, "Efficacy of the exhalation delivery system with
fluticasone (EDS-FLU) in patients who remain symptomatic on
standard nasal steroid sprays"1 in the International
Forum of Allergy & Rhinology, the journal of the
American Rhinologic Society. EDS-FLU is U.S. Food and Drug
Administration (FDA) approved for the treatment of nasal polyps in
patients 18 years of age or older and is marketed under the trade
name XHANCE® (fluticasone propionate) for the up to 1 in 3 patients
whose chronic rhinosinusitis is complicated by nasal polyps.
First-line treatment for the 10 million patients who suffer with
nasal polyps is often conventional, over the counter, inhaled
steroids that were originally approved for allergic rhinitis (AR).
But unlike AR, the nasal polyps associated with chronic
rhinosinusitis start deep in the nasal cavity where nasal sprays
usually do not reach. This analysis of data from the Phase 3 XHANCE
studies showed comparable improvement across multiple outcome
measures for patients receiving XHANCE, regardless of whether they
were previously treated with a conventional inhaled nasal
spray.
"It is very common for people suffering from symptoms of chronic
rhinosinusitis, especially those with nasal polyps, to feel
frustrated or experience persistent symptoms despite first-line
treatment with standard conventional steroid nasal sprays," said
Brent Senior, M.D., Professor of
Otolaryngology and Vice Chair of Academics and Outreach at the
University of North Carolina and lead
author of the paper. "This analysis of pooled data from XHANCE
pivotal trials finds that people who reported changing over to
XHANCE from a conventional steroid nasal spray improved
substantially across a range of measures, and just as much as the
whole study population. This supports the value of using XHANCE to
put medicine high and deep in the nose, where standard nasal sprays
usually do not reach."
"Published treatment guidelines for chronic rhinosinusitis,
including nasal polyps, call for treating first with inexpensive
and relatively safe topically acting nasal steroids," said
John Bosso, M.D., Medical Director
and Clinical Associate of Allergy at the University of
Pennsylvania. "This publication is important because it shows
that when first-line treatment isn't meeting the need, XHANCE is an
important option that may help before a patient either gives up in
frustration or feels compelled to move on to surgery or chronic use
of an injectable biologic medication. This new information supports
an emerging expert consensus that a stepwise care pathway for
patients with chronic rhinosinusitis and nasal polyps can optimize
medical therapy. Conventional nasal steroids will often be
considered first, XHANCE should be considered for those who do
not succeed, surgical treatment should be considered for those not
succeeding with appropriate medical therapy, and eventually
expensive biologics are an option for those who require it."
"We are excited to see publication of this data that supports
the value of XHANCE in the continuum of care," said Ramy Mahmoud, M.D., MPH, President of Optinose.
"The Optinose team is focused on identifying opportunities to help
improve the standard of care for ENT and allergy patients, which
includes studying ways to treat the inflammatory processes that
characterize this disease."
About the Study
This post-hoc analysis explored pooled
data from the previously published NAVIGATE I and NAVIGATE II
trials to compare the benefit of EDS-FLU vs EDS-placebo for the 45%
of patients who reported use of a standard nasal steroid spray at
study entry (median treatment duration of approximately 3 years) to
the overall study population. Across multiple measures, including
all 4 cardinal symptoms, patients who reported use of a standard
nasal steroid spray at study entry were observed to have comparable
improvement to patients who did not report prior use of
conventional steroid nasal sprays at study entry.
About XHANCE (EDS-FLU)
EDS-FLU uses an Optinose
Exhalation Delivery System (EDS) designed to deliver a topical
anti-inflammatory corticosteroid to the high and deep regions of
the nasal cavity where nasal polyps originate. Ten million patients
suffer from nasal polyps which leads to approximately $5.7 billion in direct costs
annually.2 EDS-FLU was approved for the treatment of
nasal polyps in patients 18 years of age or older by the U.S. Food
and Drug Administration in September
2017 under the trade name XHANCE®.
Important Safety Information
CONTRAINDICATIONS: Hypersensitivity to any ingredient in
XHANCE.
WARNINGS AND PRECAUTIONS:
- Local Nasal Effects: epistaxis, erosion, ulceration, septal
perforation, Candida albicans infection, and impaired wound
healing. Monitor patients periodically for signs of possible
changes on the nasal mucosa. Avoid use in patients with recent
nasal ulcerations, nasal surgery, or nasal trauma.
- Close monitoring for glaucoma and cataracts is warranted.
- Hypersensitivity reactions (e.g., anaphylaxis, angioedema,
urticaria, contact dermatitis, rash, hypotension, and bronchospasm)
have been reported after administration of fluticasone propionate.
Discontinue XHANCE if such reactions occur.
- Immunosuppression: potential increased susceptibility to or
worsening of infections (e.g., existing tuberculosis; fungal,
bacterial, viral, or parasitic infection; ocular herpes simplex).
Use with caution in patients with these infections. More serious or
even fatal course of chickenpox or measles can occur in susceptible
patients.
- Hypercorticism and adrenal suppression may occur with very high
dosages or at the regular dosage in susceptible individuals. If
such changes occur, discontinue XHANCE slowly.
- Patients with major risk factors for decreased bone mineral
content should be monitored and treated with established standards
of care.
ADVERSE REACTIONS: The most common adverse reactions
(incidence ≥ 3%) are epistaxis, nasal septal ulceration,
nasopharyngitis, nasal mucosal erythema, nasal mucosal ulcerations,
nasal congestion, acute sinusitis, nasal septal erythema, headache,
and pharyngitis.
DRUG INTERACTIONS: Strong cytochrome P450 3A4
inhibitors (e.g., ritonavir, ketoconazole): Use not recommended.
May increase risk of systemic corticosteroid effects.
USE IN SPECIFIC POPULATIONS: Hepatic impairment.
Monitor patients for signs of increased drug exposure.
INDICATION AND USAGE: XHANCE is a corticosteroid
indicated for the treatment of nasal polyps in patients 18 years of
age or older.
About Optinose
Optinose is a global specialty
pharmaceutical company focused on serving the needs of patients
cared for by ear, nose, and throat (ENT) and allergy specialists.
To learn more, please visit www.optinose.com or follow us on
Twitter and LinkedIn.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the U.S. Private Securities Litigation Reform Act of
1995. All statements that are not historical facts are hereby
identified as forward-looking statements for this purpose and
include, among others, statements relating to the potential
benefits of XHANCE®, the potential emerging expert consensus for a
stepwise care pathway for patients with chronic rhinosinusitis and
nasal polyps and the role of XHANCE in the continuum of care and
other statements regarding the Company's future operations,
prospects, objectives and other future events. Forward-looking
statements are based upon management's current expectations and
assumptions and are subject to a number of risks, uncertainties and
other factors that could cause actual results and events to differ
materially and adversely from those indicated by such
forward-looking statements including, among others, potential for
varying interpretation of clinical trial results and the risks,
uncertainties and other factors discussed under the caption "Item
1A. Risk Factors" and elsewhere in our most recent Form 10-K and
Form 10-Q filings with the Securities and Exchange Commission -
which are available at www.sec.gov. As a result, you are cautioned
not to place undue reliance on any forward-looking statements. Any
forward-looking statements made in this press release speak only as
of the date of this press release, and we undertake no obligation
to update such forward-looking statements, whether as a result of
new information, future developments or otherwise.
References
1- Senior BA, Schlosser RJ, Bosso
J, Soler ZM. Efficacy of the exhalation delivery system with
fluticasone in patients who remain symptomatic on standard nasal
steroid sprays. Int Forum Allergy Rhinol. 2020 Sept 24. doi:
10.1002/alr.22693. [Epub ahead of print]
2- Bhattacharyya et al. Laryngoscope.
2019;129(9):1969-1975.
Investor Relations Contact
Jonathan Neely
jonathan.neely@optinose.com
267-521-0531
Media Contact
Becky
Kern
becky@greenroompr.com
914-772-2310
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SOURCE Optinose