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Optinose Announces Publication of Pivotal Efficacy and Long-Term Safety Data for XHANCE in Peer Reviewed Journals | ||
By: Nasdaq / GlobeNewswire - 21 Jun 2018 | Back to overview list |
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NAVIGATE II: XHANCE produced significant improvement in both co-primary outcome measures, congestion/obstruction at week four and total polyp grade at week 16 EXHANCE-12: Over one year of treatment, XHANCE 372 mcg twice daily was well tolerated in patients with chronic sinusitis with or without nasal polyps YARDLEY, Pa., June 21, 2018 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced that results of the Phase 3 NAVIGATE II trial and the EXHANCE-12 trial were published in peer-reviewed journals: the Journal of Allergy and Clinical Immunology1 and the International Forum of Allergy & Rhinology2, respectively. “We are pleased to announce the peer-reviewed publication of these important data from the development program that supported the FDA approval of XHANCE for the indication ‘treatment for nasal polyps’ in adults,” said Ramy Mahmoud, M.D., MPH, President and Chief Operating Officer of Optinose. “The team at Optinose thanks the investigators and patients involved in NAVIGATE II and EXHANCE-12. Their willingness to conduct and participate in these studies was a crucial element in our success. We look forward to continuing to conduct clinical research with XHANCE, including the planned initiation in the fourth quarter of 2018 of our pivotal program evaluating XHANCE for the new indication ‘treatment of chronic sinusitis,’ an indication that has never previously been achieved for a pharmaceutical product.” NAVIGATE II and EXHANCE-12 were part of a comprehensive development program consisting of five clinical trials evaluating XHANCETM in over 1,500 adult patients; including two randomized, double?blinded, placebo?controlled Phase 3 pivotal clinical trials in adults with nasal polyposis and two supportive open?label Phase 3 clinical trials in adults with symptoms of chronic sinusitis with or without nasal polyps. Based upon the results of this program, the U.S. Food & Drug Administration (FDA) approved XHANCE for the treatment of nasal polyps in patients 18 years of age and older in September 2017. About NAVIGATE II1 NAVIGATE II was a 24-week study designed to assess the efficacy and safety of XHANCE versus an Exhalation Delivery System (EDS) with placebo in adults. Patients all had nasal polyps (NP) and moderate-to-severe nasal congestion/obstruction at entry. Patients were randomized to receive XHANCE (including the FDA-approved doses, 186 and 372 mcg) or EDS-placebo twice daily for the 16-week, double-blind phase. Patients who completed this double?blind phase were permitted to continue in an open?label extension phase in which all patients received 372 mcg of XHANCE twice daily for up to eight additional weeks. All patients and investigators remained blinded to the original treatment during the open?label phase. At the start of the trial, patients were moderate to severe, with 87% reporting prior corticosteroid treatment for nasal polyps and 51% reporting prior sinus surgery and/or polypectomy. Both approved doses of XHANCE (186 and 372 mcg) produced statistically significant reductions in both co-primary outcome measures; change in nasal congestion/obstruction symptoms from baseline to week four and change in total nasal polyp grade from baseline to week 16. In addition to the co?primary efficacy endpoints, NAVIGATE II included assessments of several important secondary endpoints, including the following:
Adverse events in this study that were possibly attributable to XHANCE were local (not systemic). Adverse events occurring more often with XHANCE versus EDS-placebo, and in at least 2% of patients, were epistaxis, nasal septal ulceration, nasopharyngitis, nasal erythema/erosion, atypical nasal congestion, nasal septal erythema, and headache. About EXHANCE-122 EXHANCE-12 was a prospective, 12-month, multicenter, open-label study evaluating the long-term safety and efficacy of XHANCE 372 mcg twice daily in chronic rhinosinusitis (CRS) patients with or without nasal polyps. Eligible patients were 18 years of age or older and had symptoms of CRS for at least 12 weeks. The presence of nasal polyps was determined by nasal endoscopy at screening. In this study, 96% of patients reported prior use of corticosteroids and 29% reported prior sinus surgery. All patients received XHANCE 372 mcg twice daily. The majority of spontaneously reported AEs were local in nature, mild in severity, and resolved spontaneously with continued use of XHANCE. The most common AEs (5%) included those coded as epistaxis (11.2%); nasal erythema (17.5%); nasal septum disorder (nasal septal erythema, 14.3%); acute sinusitis (13.9%); nasal septal erosion or ulceration (11.2%); headache (9.4%); and upper respiratory infection (7.6%). Important efficacy measures in EXHANCE-12 included:
Patient Global Impression of Change: At month 12, more than 85% of patients reported improvement and more than 64% reported being ‘‘much’’ or ‘‘very much’’ improved. Other efficacy measures included: Lund?Kennedy scoring of endoscopically observed nasal pathology, indicators of potential need for surgery, and others. About CRS with and without nasal polyps About XHANCE IMPORTANT SAFETY INFORMATION for XHANCE WARNINGS AND PRECAUTIONS:
ADVERSE REACTIONS: DRUG INTERACTIONS: USE IN SPECIFIC POPULATIONS INDICATIONS AND USAGE: Please see full Prescribing Information at www.xhance.com. About Optinose Cautionary Note on Forward-Looking Statements References 1 – Leopold DA, Elkayam D, Messina JC, Kosik-Gonzalez C, Djupesland PG, Mahmoud RA, NAVIGATE II: randomized, double-blind trial of the exhalation delivery system with fluticasone (EDS-FLU) for nasal polyposis, Journal of Allergy and Clinical Immunology (2018), 2 – Palmer JN, Jacobsen KW, Messina JC, Kosik-Gonzalez C, Djupesland PG, Mahmoud RA. EXHANCE-12: 1-Year Study of the exhalation delivery system with fluticasone (EDS-FLU) in chronic rhinosinusitis. Int Forum Allergy Rhinol. 2018;00:1-8. Optinose Investor Contact Optinose Media Contact |
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Copyright 2018 Nasdaq / GlobeNewswire | Back to overview list |