New Peer-Reviewed Data Highlight the Benefits of XHANCE in Chronic Rhinosinusitis Patients with or without Prior Sinus Surgery
2024年9月5日 - 10:00PM
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, “EDS-FLU efficacy in patients with chronic rhinosinusitis
with or without prior sinus surgery in ReOpen1 and ReOpen2
randomized controlled trials”1 in the International Forum of
Allergy & Rhinology, the journal of the American Rhinologic
Society.
As discussed in the publication, the inability of topical
medications to reach the region of the sinus cavities is a
potential reason for lack of efficacy in chronic rhinosinusitis
(CRS), particularly the common type without nasal polyps. This is
different from rhinitis, which is effectively treated by
standard-delivery topical medication, and also different from
treating nasal polyps, which can sometimes extend down into areas
reached by standard-delivery nasal sprays.
One purpose of endoscopic sinus surgery (ESS) is to enable
delivery of medications into the sinus cavities. The Exhalation
Delivery System™ with fluticasone (EDS-FLU; XHANCE (fluticasone
propionate) nasal spray) creates unique biomechanics during use
that enables deposition of corticosteroid into sinuses and sinus
drainage pathways and is proven effective for treatment of chronic
sinusitis (also called chronic rhinosinusitis without nasal
polyps). However, it was not known if the efficacy of this novel
approach was different in patients with operated versus unoperated
sinuses. Two 24-week randomized trials (ReOpen1 and ReOpen2)
evaluated XHANCE versus EDS-placebo in patients with CRS and were
analyzed for the groups of patients with and without prior sinus
surgery.
In these trials, XHANCE improved symptoms, sinus opacification,
and quality of life in both groups of CRS patients either with or
without prior sinus surgery, indicating that previous surgery is
not required for patients with CRS to experience the benefits of
treatment with XHANCE and that XHANCE can be helpful for patients
even after surgery.
About OptinoseOptinose is a 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 X
and LinkedIn.
About XHANCEXHANCE is a drug-device combination
product that uses the Exhalation Delivery System™ (also known as
the EDS®) designed to deliver a topical steroid to the high and
deep regions of the nasal cavity where sinuses ventilate and drain.
XHANCE is approved by the U.S. Food and Drug
Administration for both the treatment of chronic
rhinosinusitis without nasal polyps (also called chronic sinusitis)
and chronic rhinosinusitis with nasal polyps (also called nasal
polyps) in patients 18 years of age or older.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS: Hypersensitivity to any
ingredient in XHANCE.
WARNINGS AND PRECAUTIONS:
- Local nasal adverse reactions,
including epistaxis, erosion, ulceration, septal perforation,
Candida albicans infection, and impaired wound healing, can occur.
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 until healing has occurred.
- Glaucoma and
cataracts may occur with long-term use. Consider referral to an
ophthalmologist in patients who develop ocular symptoms or use
XHANCE long-term.
- 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
and infections can occur, including 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.
- Assess for decrease
in bone mineral density initially and periodically thereafter.
ADVERSE REACTIONS:
- Chronic rhinosinusitis without
nasal polyps: The most common adverse reactions (incidence ≥3%) are
epistaxis, headache, and nasopharyngitis.
- Chronic
rhinosinusitis with nasal polyps: 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.
Please see full Prescribing Information, including
Instructions for Use
References 1- Wise SK, Adappa ND, Chandra RK,
et al. EDS-FLU efficacy in patients with chronic rhinosinusitis
with or without prior sinus surgery in ReOpen1 and ReOpen2
randomized controlled trials. Int Forum Allergy Rhinol. 2024;1-12.
https://doi.org/10.1002/alr.23434 [Epub ahead of print]
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 for the treatment of chronic rhinosinusitis with
and without nasal polyps; 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: physician and patient acceptance of XHANCE (including
for its new indication); potential for varying interpretation of
clinical trial results of XHANCE; 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 the Company undertakes no obligation to
update such forward-looking statements, whether as a result of new
information, future developments or otherwise.
Optinose Investor Contact
Jonathan Neelyjonathan.neely@optinose.com267.521.0531
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