FDA Events for OptiNose (OPTN)
This section highlights FDA-related milestones and regulatory updates for drugs developed by OptiNose (OPTN).
Over the past two years, OptiNose has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
XHANCE. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
XHANCE - FDA Regulatory Timeline and Events
XHANCE is a drug developed by OptiNose for the following indication: Treatment for chronic rhinosinusitis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- XHANCE
- Announced Date:
- September 5, 2024
- Indication:
- Treatment for chronic rhinosinusitis
Announcement
Optinose 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.
AI Summary
Optinose announced that a research paper titled "EDS-FLU efficacy in patients with chronic rhinosinusitis with or without prior sinus surgery in ReOpen1 and ReOpen2 randomized controlled trials" has been published in the International Forum of Allergy & Rhinology, the journal of the American Rhinologic Society. The paper examines whether previous sinus surgery affects the benefits of using XHANCE, a novel therapy that uses the Exhalation Delivery System™ with fluticasone (EDS-FLU) to deliver corticosteroid deeper into the nasal cavity and sinuses.
Results from two 24-week trials, ReOpen1 and ReOpen2, show that XHANCE improved symptoms, reduced sinus opacification, and enhanced quality of life in patients with chronic rhinosinusitis, regardless of prior sinus surgery. This research supports that XHANCE is effective even for patients who have not undergone sinus surgery, highlighting its potential as an important treatment option for chronic rhinosinusitis.
Read Announcement- Drug:
- XHANCE
- Announced Date:
- June 27, 2024
- Indication:
- Treatment for chronic rhinosinusitis
Announcement
Optinose 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.
AI Summary
Optinose announced that its prescription medication XHANCE® (fluticasone propionate) has been added to Express Scripts’ national formularies, including the National Preferred, Flex, and Basic plans. These formularies represent some of the largest in the U.S., covering more than 24 million lives. This inclusion is expected to improve patient access to XHANCE®, which is approved for treating chronic rhinosinusitis, including the common type without nasal polyps.
According to CEO Ramy Mahmoud, this update is an important milestone that will provide both doctors and patients with a safe, evidence-based treatment option for chronic sinusitis. The addition to these formularies is seen as a significant step toward expanding the reach of a unique therapy designed for adults suffering from chronic sinusitis, ultimately making it easier for patients to receive the care they need.
Read Announcement
OptiNose FDA Events - Frequently Asked Questions
As of now, OptiNose (OPTN) has not received any FDA approvals for its therapy in the last two years.
In the past two years, OptiNose (OPTN) has reported FDA regulatory activity for XHANCE.
The most recent FDA-related event for OptiNose occurred on September 5, 2024, involving XHANCE. The update was categorized as "Publication," with the company reporting: "Optinose 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."
Currently, OptiNose has one therapy (XHANCE) targeting the following condition: Treatment for chronic rhinosinusitis.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:OPTN) was last updated on 7/13/2025 by MarketBeat.com Staff
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