Expanded Access to XHANCE with Addition to National Commercial Formularies
27 Junho 2024 - 8:00AM
Optinose (NASDAQ:OPTN), a pharmaceutical company focused on
patients treated by ear, nose and throat (ENT) and allergy
specialists, today announced that XHANCE® (fluticasone propionate)
has been added to Express Scripts’ national formularies, including
the National Preferred, Flex, and Basic formularies, among the
largest commercial formularies in the U.S. with more than 24
million lives.
“XHANCE is approved for treatment of chronic rhinosinusitis and,
importantly, is the only medication approved for by far the most
common type - without nasal polyps, so we are very pleased that
Express Scripts has added XHANCE as a preferred option to these
formularies,” said Ramy Mahmoud, MD, MPH, CEO
of Optinose. “Our recently published landmark studies in
chronic sinusitis, and the recent FDA approval, mark a breakthrough
for doctors and patients who want safe and effective treatment for
one the most common diagnoses in adult outpatient medicine. We look
forward to seeing the addition of XHANCE to these Express Scripts
national formularies result in increased patient access to the only
evidence-based prescription treatment for this disease.”
Chronic sinusitis (also referred as chronic rhinosinusitis)
affects approximately 30 million adults in the United States.
Research shows that the disease impairs quality of life to a
similar degree as other serious chronic conditions, such as chronic
obstructive pulmonary disease, sciatica, or migraine. The ReOpen
clinical trial program was the first ever controlled trial program
we are aware of to demonstrate significant improvement in both
symptoms and inflammation inside the sinuses for patients with
chronic sinusitis, regardless of whether nasal polyps are present,
and to demonstrate significant reduction in the number of acute
exacerbations.1
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 referred to
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
- 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, Volume 12, Issue 4,
2024, Pages 1049-1061, ISSN 2213-2198,
https://doi.org/10.1016/j.jaip.2023.12.016.
(https://www.sciencedirect.com/science/article/pii/S221321982301365X)
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 benefits of
XHANCE for the treatment of chronic sinusitis (also called chronic
rhinosinusitis) with and without nasal polyps; the potential for
XHANCE to become a preferred option for the treatment of chronic
sinusitis; the benefits of XHANCE being added to the Express
Scripts’ national formularies; the benefits of the Exhalation
Delivery System; 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 new indication (treatment
of adults with chronic rhinosinusitis without nasal polyps); the
Company’s ability to maintain adequate third party reimbursement
for XHANCE (including its new indication); potential for varying
interpretation of clinical trial results of XHANCE; 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
OptiNose (NASDAQ:OPTN)
Gráfico Histórico do Ativo
De Dez 2024 até Jan 2025
OptiNose (NASDAQ:OPTN)
Gráfico Histórico do Ativo
De Jan 2024 até Jan 2025