Optinose (NASDAQ:OPTN), a pharmaceutical
company focused on patients treated by ear, nose and throat (ENT)
and allergy specialists, today announced peer-reviewed publication
of results from both ReOpen1 and ReOpen2 in the Journal of Allergy
and Clinical Immunology: In Practice1.
The ReOpen program evaluated XHANCE for treatment of adults with
chronic sinusitis (chronic rhinosinusitis). A drug-device
combination product, XHANCE® (fluticasone propionate) nasal spray
uniquely combines a widely used nasal anti-inflammatory drug with
the Exhalation Delivery System™, an innovative delivery system
designed to deliver the medication high and deep into
difficult-to-access sinuses and sinonasal drainage tracts.
“Patients with chronic sinusitis often suffer for years and may
use multiple over-the-counter treatments in a search for ways to
alleviate their symptoms. The burden of chronic sinusitis has been
measured and is serious, with a degree of impaired quality of life
and functioning comparable to other serious chronic conditions such
as chronic heart failure, sciatica, or migraine. Chronic sinusitis
is also common: data suggests it is one of the top diagnoses in
adult outpatient physician visits. Although surgery is available,
there has never been a medication approved by the FDA as safe and
effective for this disease,” said Ramy Mahmoud, MD, MPH, CEO of
Optinose. “Having a proven effective medication would finally allow
doctors to have confidence that they can offer some relief to tens
of millions of people suffering from this burdensome inflammatory
condition.”
As detailed in the new scientific publication Efficacy of
EDS-FLU for Chronic Rhinosinusitis: Two Randomized Controlled
Trials (ReOpen1 and ReOpen2), both trials showed statistically
significant improvement in symptoms, and in inflammation inside the
sinuses, in patients with chronic sinusitis (chronic
rhinosinusitis) treated with XHANCE compared to patients receiving
a vehicle combined with the Exhalation Delivery System
(EDS-placebo). The primary endpoints include a composite symptom
score (congestion, facial pain or pressure, and nasal discharge)
and CT scans of the sinuses to objectively measure change in
inflammation inside the sinus cavities. In additional statistically
well-controlled measures, these trials also showed that XHANCE
reduced the incidence of acute disease exacerbations by more than
half and that treatment significantly reduced symptoms even for
patients who entered the trials with symptoms despite using a
standard-delivery nasal spray steroid, which are now generally
available at prescription strength as over-the-counter
treatments.
The safety profile and tolerability of XHANCE for patients in
the ReOpen trials was generally consistent with its currently
labeled safety profile. The most common adverse reactions
(incidence ≥ 3%) in the ReOpen program were epistaxis, headache,
and nasopharyngitis.
“With the help of patients and doctors in many countries, after
years of effort, we are thrilled to see that results from these two
pivotal trials are now available in a peer reviewed publication.
Not only do these data support the sNDA we filed with FDA in 2023,”
stated John Messina, PharmD, Senior Vice President of Clinical
Research and Medical Affairs, “but they represent the first body of
large, controlled trial evidence we are aware of showing that any
nasal medication can produce improvement in symptoms and can reduce
inflammation inside the sinus cavities of patients suffering from
chronic sinusitis either with or without concurrent nasal polyps.
Our team is proud of this breakthrough in the treatment of chronic
sinusitis, and we sincerely thank the healthcare professionals who
advised us along the way as well as those at our research sites and
all the patients whose participation made this program
possible.”
About the ReOpen ProgramThe ReOpen program
comprised two global, randomized, double-blind, placebo-controlled
Phase 3 trials that evaluated the efficacy and safety of one or two
sprays of XHANCE in each nostril twice daily, over 24 weeks, in
patients suffering from chronic sinusitis. In ReOpen1, the first of
the two trials, 332 chronic sinusitis patients either with or
without concurrent nasal polyps were treated. In ReOpen2, 222
chronic sinusitis patients who did not have polyps in the nasal
cavity were treated. The co-primary endpoints were change from
baseline in symptoms, as measured by composite symptom score (nasal
congestion, facial pain or pressure, and nasal discharge) at the
end of week 4, and change in inflammation inside the sinus
cavities, as measured by CT scans (change in the average of the
percentages of volume occupied by disease in the ethmoid and
maxillary sinuses) at week 24. The ReOpen trial program is a
landmark research program that included the first ever large,
controlled trials we are aware of to demonstrate that any nasal
medication produces significant improvement in both symptoms and
inflammation inside the sinuses for patients with chronic
sinusitis, regardless of whether or not nasal polyps are present,
and to demonstrate significant reduction in the number of acute
exacerbations.
About Chronic Sinusitis
Chronic sinusitis (CS), also called “chronic
rhinosinusitis”, has been cited as the second most common chronic
disease of adults in the U.S.2 It is a serious chronic inflammatory
disease affecting as many as 30 million adults in the U.S. and
burdens the U.S. economy with over $30 billion in direct and
indirect costs every year.3 CS is characterized by chronic
inflammation affecting the paranasal sinuses and the nasal cavity,
where the openings from the sinuses normally ventilate and drain.
Chronic sinusitis is associated with symptoms that persist for at
least 12 weeks, with many patients suffering for years. In
addition, the condition is often associated with multiple acute
exacerbations that require medical care and result in substantial
use of antibiotics. In some patients, chronic sino-nasal
inflammation is accompanied by development of polyps in the nasal
cavities, referred to as nasal polyposis. Today, there are no
FDA-approved drug treatments for the majority of chronic sinusitis
patients, those who do not have polyps in the nasal cavity,
although there are medications, including XHANCE, that have been
approved by FDA for treatment of the smaller population of chronic
rhinosinusitis patients who also have nasal polyps. The term
“chronic rhinosinusitis” is sometimes used instead of “chronic
sinusitis” to acknowledge that inflammation inside the sinuses is
typically accompanied by inflammation in the nasal cavity.
About OptinoseOptinose 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 X
and LinkedIn.
About XHANCEXHANCE® is a
drug-device combination product that uses the Exhalation Delivery
System™ (also referred to as the EDS®) designed to deliver a
topical anti-inflammatory 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 the treatment of chronic
rhinosinusitis with nasal polyps in patients 18 years of age or
older and has been studied for treatment of chronic sinusitis
(notably including patients without polyps in the nasal cavity) in
two phase 3 trials, ReOpen1 and ReOpen2. These trials are the first
ever that we are aware of that show improvement in both symptoms
and inflammation inside the sinuses, and reduction in acute
exacerbations of disease, with a nasal therapy for chronic
sinusitis patients, including patients with or without nasal
polyps. If approved, XHANCE may be the first drug ever FDA-approved
for treatment of chronic rhinosinusitis either with or without
nasal polyps.
Important Safety Information
CONTRAINDICATIONS: Hypersensitivity to any
ingredient in XHANCE.
WARNINGS AND PRECAUTIONS:
- Local Nasal Adverse Reactions:
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 until healing has occurred.
- 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 and Risk of
Infection: 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.
Please see full Prescribing Information, including Instructions
for Use
References
- James N. Palmer, Nithin D. Adappa, Rakesh K. Chandra, Greg E.
Davis, Mahboobeh Mahdavinia, John Messina, Randall A. Ow, Zara M.
Patel, Anju T. Peters, Harry Sacks, Rodney J. Schlosser, Raj
Sindwani, Zachary M. Soler, Andrew A. White, Sarah K. Wise, Ramy A.
Mahmoud, Efficacy of EDS-FLU for Chronic Rhinosinusitis: Two
Randomized Controlled Trials (ReOpen1 and ReOpen2), The Journal of
Allergy and Clinical Immunology: In Practice, 2024,, ISSN
2213-2198, https://doi.org/10.1016/j.jaip.2023.12.016.
(https://www.sciencedirect.com/science/article/pii/S221321982301365X)
- Hamilos DL. Chronic rhinosinusitis: epidemiology and medical
management. J Allergy Clin Immunol. 2011 Oct;128(4):693-707; quiz
708-9. doi: 10.1016/j.jaci.2011.08.004. Epub 2011 Sep 3. PMID:
21890184.
- Palmer JN, Messina JC, Biletch R, Grosel K, Mahmoud RA. A
cross-sectional, population-based survey of U.S. adults with
symptoms of chronic rhinosinusitis. Allergy Asthma Proc. 2019 Jan
14;40(1):48-56. doi: 10.2500/aap.2019.40.4182. PMID: 30582496.
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 for
XHANCE to be the first FDA approved drug product for chronic
rhinosinusitis and the potential benefits of such label expansion;
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 for its current and any potential
future indication; potential for varying interpretation of clinical
trial results of XHANCE for the treatment of chronic
rhinosinusitis; potential that the FDA does not meet the PDUFA
target goal date; risks and uncertainties relating to FDA approval
of XHANCE for the treatment of chronic rhinosinusitis; the
prevalence of chronic sinusitis and market opportunities for XHANCE
may be smaller than the Company expects; 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.
Optinose Investor ContactJonathan
Neelyjonathan.neely@optinose.com267.521.0531
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