Optinose Announces FDA Acceptance of Supplemental New Drug Application for XHANCE
May 04 2023 - 7:00AM
Optinose (NASDAQ:OPTN), a pharmaceutical company focused on
patients treated by ear, nose and throat (ENT) and allergy
specialists, today announced the U.S. Food and Drug Administration
(FDA) accepted for review its supplemental new drug application
(sNDA) requesting approval of XHANCE as a treatment for chronic
rhinosinusitis. XHANCE® (fluticasone propionate) nasal spray is a
drug-device combination product that combines the most widely used
nasal anti-inflammatory drug with the innovative Exhalation
Delivery System™ (EDS™). The EDS is designed to uniquely deliver
drug high and deep into difficult-to-access sinuses and sinonasal
drainage tracts. The sNDA submission is based on data from the two
Phase 3 clinical trials in patients with chronic sinusitis from the
ReOpen Program and has been assigned a Prescription Drug User Fee
Act (PDUFA) target goal date of December 16, 2023.
“Chronic sinusitis is one of the top diagnoses made in adult
outpatient visits, with approximately 10 million physician office
visits coded annually, yet there is a high level of patient
dissatisfaction and suffering and no FDA approved drug treatments
except for patients who also have nasal polyps,” stated Ramy
Mahmoud, MD, MPH, CEO of Optinose. “We are excited to see our study
data under FDA review as we believe the ReOpen trials found
important benefits that XHANCE could offer to physicians and their
patients as a first-ever drug approved to treat chronic
rhinosinusitis.”
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 (OPN-375) in each nostril twice daily, over 24
weeks, in patients suffering from chronic sinusitis (CS). In
ReOpen1, the first of the two trials, 332 CS patients were treated,
either with or without concurrent nasal polyps. In ReOpen2, the
second of the two trials, 222 CS patients were treated, all of whom
did not have polyps in the nasal cavity. The co-primary endpoints
were change from baseline in symptoms, as measured by a composite
score of patient-reported symptoms (including nasal congestion,
facial pain or pressure, and nasal discharge) at the end of week 4,
and objective change in inflammation inside the sinus cavities, as
measured by CT scans assessing the change in the average of the
percentages of volume occupied by disease across the ethmoid and
maxillary sinuses. The ReOpen trial program is a landmark research
program because these are the first ever large, controlled trials
we are aware of with any nasal medication to demonstrate
significant improvement of both symptoms and inflammation inside
the sinuses and to demonstrate 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 US1. It is a serious chronic inflammatory
disease affecting as many as 30 million adults in the United States
and burdens the U.S. economy with over $30 billion in direct and
indirect costs every year.2 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 Twitter
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
- 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
StatementsThis 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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