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Board of Directors
R. John Fletcher R. John Fletcher, age 77, founded Fletcher Spaght Inc., a strategy consulting and venture capital firm, in 1983 and as its managing partner emeritus, remains active with the company, advising both the consulting practice and venture capital activities with analytical insights and creative solutions derived from his years of experience with clients, portfolio companies and the investment community. Since 2001, Mr. Fletcher has al…
Corporate Compliance
Compliance Program OptiNose US, Inc. and its parent, affiliate, and subsidiary companies (collectively, “Optinose”) are committed to conducting business in compliance with all applicable federal and state laws and regulations. To that end, Optinose has established and maintains an effective Compliance Program in accordance with the “Compliance Program Guidance for Pharmaceutical Manufacturers,” published by the Office of Inspector General, U.S….
XHANCE® (fluticasone propionate)
in March and June 2022 and submitted a supplemental new drug application (sNDA) in February 2023. The sNDA was approved in March 2024. In the future, as appropriate, we intend to broaden, through potential collaborations, our commercialization efforts to additional primary care physicians that we believe treat an additional estimated 6.25 million U.S. patients with chronic rhinosinusitis. In addition, at some point in the future, we intend to con…
Driving Directions to OptiNose US, Inc.
777 Township Line Road, SUITE 300, Yardley, PA 19067 GPS note: The city, state may come up as “Morrisville, PA” From Points South (Philadelphia) Take I-95 North to I-295 East (Stay left on I-95 North and it will become I-295 East) Take exit 8 Newtown/Yardley (formerly exit 49). Turn left at the traffic light at the top of the ramp, onto Route 332 West. You will cross over I-95; make second left onto Stony Hill Road (this is a very short dista…
Research & Development
Other Drug-Device Product Candidates Combining Drug with Exhalation Delivery Systems Although our current focus is to prioritize the successful commercialization of XHANCE for the ENT and allergy specialty segment, we may apply or out-license our Exhalation Delivery System (EDS) technology to other product candidates across a broad range of disease areas. For example, by placing drug high and deep in the nose, in regions where cranial nerves con…
Contact Us
To report a side effect or product complaint, call 1-833-678-6673 or contact the FDA directly by calling 1-800-FDA-1088 or visiting www.fda.gov/medwatch. For all other inquiries, complete the form below to be contacted by Optinose. Inquiry Type* Select Option Business Development/Partnership Opportunities Commercial Inquiries Medical/Scientific Questions Investor Inquiries Clinical Services (CRO) Quest…
Our Products
In September 2017, we received FDA approval for XHANCE® (fluticasone propionate). Please see Instructions for Use, Important Safety Information, and full Prescribing Information at www.XHANCE.com. ONZETRA® Xsail® (sumatriptan nasal powder), licensed to Currax Pharmaceuticals LLC, has been approved for the delivery of low-dose sumatriptan using an Optinose Bi-Directional™ Exhalation Delivery System. See Instructions for Use, Important S…
Our Company
We are focused on value creation, starting with our work on a unique and novel drug delivery concept known as Bi-Directional™ Exhalation Delivery Systems. The innovative mechanism of action of the first Optinose technology is designed to enable broad, consistent drug delivery high and deep in the nasal passages, leveraging the mucosal surfaces as a potential target for the treatment of both local and systemic diseases. As of September 2017, two…