Xhance (fluticasone propionate intranasal spray) / Paratek Pharmaceuticals - LARVOL DELTA

Paratek Pharmaceuticals Acquires Optinose in $330 Million Deal to Expand Drug Portfolio (GeneOnline) - "Paratek Pharmaceuticals has finalized the acquisition of Optinose in a deal valued at approximately $330 million. The transaction expands Paratek’s commercial portfolio, adding new products to its lineup and strengthening its position in the pharmaceutical market. The acquisition marks a significant step for Paratek as it integrates Optinose’s assets into its operations. Optinose is known for its innovative approaches to drug delivery, particularly in treating chronic nasal conditions. By acquiring the company, Paratek gains access to these technologies and products, potentially enhancing its ability to address unmet medical needs. The financial details of the agreement place the value of the acquisition at nearly $330 million, underscoring the strategic importance of this move for both companies involved."

M&A • CNS Disorders • Migraine • Pain

Analysis of FDA adverse event reports on fluticasone nasal sprays: Xhance vs. Flonase (COSM 2025) - "Despite FAERS limitations, this analysis suggests higher rates of headache and increased odds of epistaxis in Xhance users compared to Flonase users. Proper Xhance administration is essential to reduce local side effects."

Adverse events • Immunology • Nasal Polyps • Otorhinolaryngology • Pain

Optinose Reports Fourth Quarter and Full Year 2024 Financial Results and Recent Operational Highlights (GlobeNewswire) - "Company reports fourth quarter and full year 2024 XHANCE net revenue of $22.4 million and $78.2 million, increases of 13% and 10% compared to prior year periods"

Sales • Chronic Rhinosinusitis With Nasal Polyps

Paratek Pharmaceuticals to Acquire Optinose, Creating Significant Commercial Expansion Opportunities for XHANCE in Chronic Rhinosinusitis (CRS) (GlobeNewswire) - "Paratek Pharmaceuticals and Optinose...announced they have entered into a definitive merger agreement under which Paratek will acquire Optinose, including its approved product XHANCE (fluticasone propionate). The transaction value is up to $330 million, with consideration payable to shareholders of up to $14 per share, including the payment of contingent value rights (CVRs) tied to future commercial milestones. This acquisition expands Paratek’s commercial portfolio...and strengthens its position as a multi-product company focused on innovative specialty therapies for primary care providers and specialists, addressing important medical health threats....Under the terms of the agreement, Paratek will acquire all of Optinose’s outstanding shares for $9 per share in cash, plus up to $5 per share in CVRs payable in the event that certain net revenue milestones are achieved by XHANCE."

M&A • Chronic Rhinosinusitis With Nasal Polyps

Re-Open 3: Efficacy and Safety of 186 Mcg of OPN-375 Nasal Spray Twice a Day (BID) in Adolescents with Chronic Rhinosinusitis Without Nasal Polyps (clinicaltrials.gov) - P3 | N=84 | Not yet recruiting | Sponsor: Optinose US Inc.

New P3 trial • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

EDS-FLU efficacy in patients with chronic rhinosinusitis with or without prior sinus surgery in ReOpen1 and ReOpen2 randomized controlled trials. (PubMed, Int Forum Allergy Rhinol) - "EDS-FLU improved symptoms, sinus opacification, and quality of life in patients with CRS with or without prior ESS, suggesting a role for EDS-FLU in both populations."

Journal • Surgery • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Efficacy of EDS-FLU for Chronic Rhinosinusitis: Two Randomized Controlled Trials (ReOpen1 and ReOpen2). (PubMed, J Allergy Clin Immunol Pract) - "EDS-FLU is the first nonsurgical treatment demonstrated to reduce symptoms, intrasinus opacification, and exacerbations in replicate randomized clinical trials in CRS, regardless of polyp status."

Clinical • Journal • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Inflammation • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Optinose Announces 3-Month Extension of FDA Review Period for the Supplemental New Drug Application for XHANCE (GlobeNewswire) - "Optinose....today announced that the U.S. Food and Drug Administration (FDA) has extended by three months the review period of its supplemental new drug application (sNDA) requesting approval of XHANCE as a treatment for chronic rhinosinusitis. The updated Prescription Drug User Fee Act (PDUFA) goal date is March 16, 2024...the FDA requested that Optinose submit additional efficacy subset analyses of existing clinical data from one of the two trials submitted in the sNDA: ReOpen1."

PDUFA date • sNDA • Sinusitis

OPN-375 Efficacy and Safety in Adolescents With Bilateral Nasal Polyps (clinicaltrials.gov) - P3 | N=120 | Recruiting | Sponsor: Optinose US Inc. | Trial completion date: Dec 2023 ➔ Mar 2026 | Trial primary completion date: Dec 2023 ➔ Mar 2026

Trial completion date • Trial primary completion date • Immunology • Nasal Polyps • Otorhinolaryngology

The Rising Cost of Rhinologic Medications. (PubMed, Ann Allergy Asthma Immunol) - "The rising cost of highly utilized medications contribute to increased patient acquisition costs and may pose barriers of drug adherence to particularly vulnerable populations."

Journal • Allergy • Immunology • Otorhinolaryngology

"Medical Moment: XHANCE gives patient his sense of smell back https://t.co/97WhYZqhxn" (@davidschull)

Clinical

OPN-375 Efficacy and Safety in Adolescents With Bilateral Nasal Polyps (clinicaltrials.gov) - P3 | N=120 | Recruiting | Sponsor: Optinose US Inc. | Trial completion date: Dec 2022 ➔ Dec 2023 | Trial primary completion date: Dec 2022 ➔ Dec 2023

Trial completion date • Trial primary completion date • Immunology • Nasal Polyps • Otorhinolaryngology

OPN-FLU-CS-3206: Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With Chronic Rhinosinusitis Without the Presence of Nasal Polyps (clinicaltrials.gov) - P3 | N=210 | Completed | Sponsor: Optinose US Inc. | Active, not recruiting ➔ Completed | N=399 ➔ 210

Enrollment change • Trial completion • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

"$OPTN Optinose Submits Supplemental New Drug Application for XHANCE Label Expansion https://t.co/XZxpcESzIK" (@stock_titan)

sNDA

Product Theater 2 - Optinose : Optimizing Topical Treatment of Nasal Polyposis: Role of XHANCE in Stepped Care (ACAAI 2022) - "Description Identify key differentiating features of the Exhalation Delivery System™, reviewing efficacy and safety data for XHANCE. Discuss the treatment algorithm for nasal polyps, and use of XHANCE for: patients whose symptoms do not resolve with a standard nasal steroid spray; optimizing topical treatment before escalating care; and medical management post-surgery."

Immunology • Nasal Polyps • Otorhinolaryngology

Efficacy of the exhalation delivery system with fluticasone (EDS-FLU) in patients with chronic rhinosinusitis with nasal polyps whose symptoms recur after sinus surgery. (PubMed, Int Forum Allergy Rhinol) - "Patients with recurrent symptoms after sinus surgery who were treated with EDS-FLU demonstrated significant symptom and quality of life improvement. Unlike unoperated patients, patients with prior ESS had a numerically but not statistically greater response to the higher dose of EDS-FLU (2 sprays per nostril BID)."

Journal • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

OPN-375 Efficacy and Safety in Adolescents With Bilateral Nasal Polyps (clinicaltrials.gov) - P3 | N=120 | Recruiting | Sponsor: Optinose US Inc. | Trial completion date: Dec 2021 ➔ Dec 2022 | Trial primary completion date: Dec 2021 ➔ Dec 2022

Trial completion date • Trial primary completion date • Immunology • Nasal Polyps • Otorhinolaryngology

Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With Chronic Sinusitis With or Without the Presence of Nasal Polyps (clinicaltrials.gov) - P3 | N=332 | Completed | Sponsor: Optinose US Inc. | Active, not recruiting ➔ Completed

Trial completion • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Non-Surgical Treatment for CRSwNP (AAAAI 2022) - "This can include Xhance, Sinuva, and various biologics. Discuss the concept of shared decision-making process. Emphasize the relationship of asthma and nasal polyps as well as how the management is intertwined."

Asthma • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Pulmonary Disease • Respiratory Diseases

Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With Chronic Sinusitis Without the Presence of Nasal Polyps (clinicaltrials.gov) - P3 | N=399 | Active, not recruiting | Sponsor: Optinose US Inc. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Nov 2021 ➔ May 2022

Enrollment closed • Trial primary completion date • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With Chronic Sinusitis With or Without the Presence of Nasal Polyps (clinicaltrials.gov) - P3; N=378; Active, not recruiting; Sponsor: Optinose US Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With Chronic Sinusitis Without the Presence of Nasal Polyps (clinicaltrials.gov) - P3; N=399; Recruiting; Sponsor: Optinose US Inc.; Trial completion date: Jun 2021 ➔ May 2022; Trial primary completion date: Apr 2021 ➔ Nov 2021

Clinical • Trial completion date • Trial primary completion date • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With Chronic Sinusitis With or Without the Presence of Nasal Polyps (clinicaltrials.gov) - P3; N=378; Recruiting; Sponsor: Optinose US Inc.; Trial primary completion date: Dec 2020 ➔ Dec 2021

Clinical • Trial primary completion date • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

OPN-375 Efficacy and Safety in Adolescents With Bilateral Nasal Polyps (clinicaltrials.gov) - P3; N=120; Recruiting; Sponsor: Optinose US Inc.; Trial completion date: Dec 2020 ➔ Dec 2021; Trial primary completion date: Oct 2020 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date • Immunology • Nasal Polyps • Otorhinolaryngology

[VIRTUAL] TOPICAL STEROID DELIVERY TO GRADES 1/2 NASAL POLYPS: EXHALATION DELIVERY SYSTEM AND CONVENTIONAL INTRANASAL SPRAY (ACAAI 2020) - "Fluorescein (2%) was delivered as two 100μL sprays per nostril from either the exhalation delivery system with fluticasone (EDS-FLU; XHANCE®) or conventional intranasal spray with mometasone (INS; Nasonex®). All NPs are coated with medication. Conventional INS delivery to the OMC is minimal, showing almost no coating of NPs with medication.Conclusions Although conventional INS delivery to the OMC is very limited, the EDS device efficiently delivers medication to polyps high and deep in the OMC, which is essential to shrink/eliminate polyps and restore sinus ventilation."

Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis