Delving into the Latest Updates on Revefenacin with Synapse

A Phase 4, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Study Comparing Improvements in Lung Function in Adults With Severe to Very Severe Chronic Obstructive Pulmonary Disease and Suboptimal Inspiratory Flow Rate Following Once-Daily Treatment Over 12 Weeks With Either Revefenacin Inhalation Solution Delivered Via Standard Jet Nebulizer or Tiotropium Delivered Via a Dry Powder Inhaler (Spiriva® HandiHaler®)

Study is a randomized, double-blind, double-dummy, parallel-group study evaluating efficacy and safety of revefenacin vs. tiotropium in adults with severe to very severe COPD and suboptimal PIFR.

Start Date07 Jan 2022

Sponsor / Collaborator

Theravance Biopharma, Inc.

[+1]

CTR20212308

/ CompletedPhase 3

一项中度至极重度慢性阻塞性肺疾病（COPD）中国受试者接受 Revefenacin 雾化吸入用溶液治疗的随机、双盲、安慰剂对照、平行研究

[Translation] A randomized, double-blind, placebo-controlled, parallel study of Revefenacin solution for inhalation in Chinese subjects with moderate to very severe chronic obstructive pulmonary disease (COPD)

在中国中度至极重度 COPD 受试者人群中，证实与安慰剂相比，revefenacin 吸入用溶液 175 mcg 每日一次雾化治疗 12 周的有效性

[Translation]

To demonstrate the efficacy of once-daily nebulized revefenacin solution for inhalation 175 mcg compared with placebo for 12 weeks in a Chinese population of subjects with moderate to very severe COPD

Start Date10 Nov 2021

Sponsor / Collaborator

The Ritedose Corp.

[+2]

100 Clinical Results associated with Revefenacin

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100 Translational Medicine associated with Revefenacin

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100 Patents (Medical) associated with Revefenacin

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41

Literatures (Medical) associated with Revefenacin

01 Jun 2024·Hospital Pharmacy

Estimating Tiotropium Wasted Doses After Adding Revefenacin to an Inpatient Formulary: A Single-Center Cross-Sectional Study

Article

Author: Guidry, Corey M. ; Neely, Stephen ; Fuller, Jordan A. ; Boylan, Paul M.

Introduction: Revefenacin is a once-daily nebulized long-acting muscarinic antagonist (LAMA). Revefenacin is supplied as single-use nebulized vials, which may be preferable and less costly for hospital and health-system pharmacies to dispense versus multidose tiotropium inhalers. Estimates of LAMA multidose inhaler wasted doses remains unknown. Methods: This was a single-center descriptive cross-sectional study conducted between January 1 2021 and December 31 2021. Adult patients 18 years and older admitted to a 500-bed academic medical center in the southern United States and were ordered multidose tiotropium packages or single-use revefenacin vials during the study period were included. Results: Among 602 inpatients, there were 705 LAMA orders: 541 tiotropium (76.7%) and 164 revefenacin (23.3%). Four hundred ninety-five tiotropium orders (91.5%) wasted between 20% and 90% of multidose packages. Approximately $24,000 tiotropium doses were wasted versus single-use revefenacin vials. Conclusion: Multidose inhalers of tiotropium dispensed to hospitalized patients contributed to wasted doses compared to nebulized single-use revefenacin vials. Opportunities exist to minimize wasted doses of multidose long-acting inhalers dispensed to hospitalized patients.

01 Mar 2023·Respiratory Medicine

Improvements in health status with revefenacin, a once-daily, nebulized, long-acting muscarinic antagonist for chronic obstructive pulmonary disease

Article

Author: Ferguson, Gary T ; Donohue, James F ; Ohar, Jill A ; Schneider, Roslyn F ; Lombardi, David A ; Johnson, Karmon

BACKGROUNDReplicate, 12-week, phase 3 trials (0126 and 0127) of once-daily nebulized revefenacin 175 μg vs placebo demonstrated significant bronchodilation and improvements in health status in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). This post hoc analysis evaluated improvement in patient-reported outcomes (PROs), including the St. George's Respiratory Questionnaire (SGRQ), COPD Assessment Test (CAT), and Clinical COPD Questionnaire (CCQ) in both women and men.METHODSParticipants were pooled from the two 12-week studies (411 [51%] women and 401 [49%] men). Changes in PROs were assessed overall and separately in men and women.RESULTSRevefenacin improved SGRQ and CAT total scores from baseline in both studies; improvement in CCQ total score reached significance only in 0126. In pooled data, a greater proportion of patients achieved clinically meaningful response in SGRQ score (≥4-unit decrease from baseline) with revefenacin vs placebo (odds ratio, 1.5; 95% confidence interval, 1.1-2.1; P = 0.012). Clinically meaningful responses were also seen in CAT (≥2-unit decrease from baseline) and CCQ (≥0.4-unit decrease from baseline) scores with revefenacin vs placebo. When stratified by sex, improvements from baseline in SGRQ, CAT, and CCQ scores following revefenacin vs placebo reached statistical significance only in women.CONCLUSIONSMaintenance treatment with revefenacin improved health status in patients with moderate to very severe COPD; however, the effect was more pronounced for women than men.CLINICALTRIALSGOV: NCT02459080; NCT02512510.

01 Mar 2022·Heart & LungQ4 · MEDICINE

Safety evaluation of revefenacin at the approved dose in patients with chronic obstructive pulmonary disease: A meta-analysis

Q4 · MEDICINE

Article

Author: Luo, Weishun ; Zan, Shuangjiang ; Liu, Baofeng

BACKGROUNDRevefenacin is the first once-daily long-acting muscarinic antagonist (LAMA) for nebulization use in maintenance therapy for patients with chronic obstructive pulmonary disease (COPD).OBJECTIVETo investigate the safety and tolerability profile of revefenacin at the approved dose (175 μg), compared with placebo and a lower dose (88 μg), for the treatment of COPD.METHODSAvailable randomized controlled trials (RCTs), both published and unpublished, were identified via databases. Risk differences (RDs) and risk ratios (RRs), with their corresponding 95% confidence intervals (CIs) were calculated as effect sizes.RESULTSOne unpublished RCT and four articles containing 5 RCTs were included. Combined results showed that there were no significant differences between COPD patients receiving 175 μg revefenacin and those receiving a placebo, concerning the risk of discontinuation due to adverse events (AEs), any all-grade AE, or any serious AE. 175 μg revefenacin also did not significantly increase the risk of antimuscarinic-related AEs, cardiovascular AEs, or 12 commonly reported AEs. Plus, a lower dose of 88 μg was shown to share a comparable safety profile with the 175 μg revefenacin. A non-significant trend towards a decrease in risks of AEs for 175 μg revefenacin was observed. The most frequently reported AE for each group was COPD worsening/exacerbation.CONCLUSIONRevefenacin at the approved dose is generally well-tolerated and safe with minimal AEs, which supports its use as a once-daily nebulized LAMA for the treatment of moderate to severe stable COPD. Additional studies are needed to complete the safety and tolerability profile.

66

News (Medical) associated with Revefenacin

17 Dec 2024

·www.prnewswire.com

Theravance Biopharma to Conduct Investor Meetings During the J.P. Morgan 43rd Annual Healthcare Conference

DUBLIN, Dec. 17, 2024 /PRNewswire/ -- Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ: TBPH) today announced that members of its management team will hold investor meetings during the 43rd Annual J.P. Morgan Healthcare Conference, January 13-16, 2025, in San Francisco, CA. To request a one-on-one meeting with the Theravance Biopharma management team, please contact us at [email protected]. About Theravance Biopharma Theravance Biopharma, Inc.'s focus is to deliver Medicines that Make a Difference® in people's lives. In pursuit of its purpose, Theravance Biopharma leverages decades of expertise, which has led to the development of FDA-approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Ampreloxetine, its late-stage investigational once-daily norepinephrine reuptake inhibitor in development for symptomatic neurogenic orthostatic hypotension (nOH) in patients with Multiple System Atrophy (MSA), has the potential to be a first in class therapy effective in treating a constellation of cardinal symptoms in MSA patients. The Company is committed to creating/driving shareholder value. For more information, please visit . THERAVANCE BIOPHARMA®, THERAVANCE® and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies (in the U.S. and certain other countries). YUPELRI® is a registered trademark of Mylan Specialty L.P., a Viatris company. Trademarks, trade names or service marks of other companies appearing in this press release are the property of their respective owners. Contact: [email protected] 650-808-4045 SOURCE Theravance Biopharma, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug Approval

20 Nov 2024

·www.prnewswire.com

Theravance Biopharma to Participate in an Upcoming Investor Conference

DUBLIN, Nov. 20, 2024 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ: TBPH) will participate in a Fireside Chat at the 7th Annual Evercore HealthCONx Conference on Tuesday, December 3 at 11:15 am EST (8:15 am PST/4:15 pm GMT) and will be hosting in-person meetings with the investment community at the conference. Webcast of the event may be accessed by visiting Theravance.com, under the Investors section, Events and Presentations. Replay of the webcast will be archived on the Company's website for 30 days. About Theravance Biopharma Theravance Biopharma, Inc.'s focus is to deliver Medicines that Make a Difference® in people's lives. In pursuit of its purpose, Theravance Biopharma leverages decades of expertise, which has led to the development of FDA-approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Ampreloxetine, its late-stage investigational once-daily norepinephrine reuptake inhibitor in development for symptomatic neurogenic orthostatic hypotension (nOH) in patients with Multiple System Atrophy (MSA), has the potential to be a first in class therapy effective in treating a constellation of cardinal symptoms in MSA patients. The Company is committed to creating/driving shareholder value. For more information, please visit . THERAVANCE BIOPHARMA®, THERAVANCE® and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies (in the U.S. and certain other countries). YUPELRI® is a registered trademark of Mylan Specialty L.P., a Viatris company. Trademarks, trade names or service marks of other companies appearing in this press release are the property of their respective owners. Contact: [email protected] 650-808-4045 SOURCE Theravance Biopharma, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug Approval

24 Oct 2024

·www.prnewswire.com

Theravance Biopharma to Report Third Quarter 2024 Financial Results on November 12, 2024

DUBLIN, Oct. 24, 2024 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ: TBPH) will report its third quarter 2024 financial results and provide a business update after market close on Tuesday, November 12, 2024. An accompanying conference call and simultaneous webcast will be hosted at 5:00 pm EST (2:00 pm PST/10:00 pm GMT) that day. Conference Call Information To participate in the live call by telephone, please pre-register here. Those interested in listening to the conference call live via the internet may do so by visiting Theravance Biopharma's website at , under the Investors section, Events and Presentations. A replay of the webcast will be available on Theravance Biopharma's website for 30 days through December 12, 2024. About Theravance Biopharma Theravance Biopharma, Inc.'s focus is to deliver Medicines that Make a Difference® in people's lives. In pursuit of its purpose, Theravance Biopharma leverages decades of expertise, which has led to the development of FDA-approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Ampreloxetine, its late-stage investigational once-daily norepinephrine reuptake inhibitor in development for symptomatic neurogenic orthostatic hypotension (nOH) in patients with Multiple System Atrophy (MSA), has the potential to be a first in class therapy effective in treating a constellation of cardinal symptoms in MSA patients. The Company is committed to creating/driving shareholder value. For more information, please visit . THERAVANCE BIOPHARMA®, THERAVANCE® and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies (in the U.S. and certain other countries). YUPELRI® is a registered trademark of Mylan Specialty L.P., a Viatris company. Trademarks, trade names or service marks of other companies appearing in this press release are the property of their respective owners. Contact: [email protected] 650-808-4045 SOURCE Theravance Biopharma, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalFinancial Statement

100 Deals associated with Revefenacin

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KEGG	Wiki	ATC	Drug Bank
D10978	Revefenacin	R03BB08	DB11855

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Pulmonary Disease, Chronic Obstructive	US	Mylan Ireland Ltd.	09 Nov 2018

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pulmonary Disease, Chronic Obstructive	NDA/BLA	CN	The Ritedose Corp.	16 Jul 2024
Pulmonary Disease, Chronic Obstructive	NDA/BLA	CN	Mylan Ireland Ltd.	16 Jul 2024
Respiratory Failure	Phase 2	US	Mylan Pharmaceuticals, Inc.	01 Nov 2020
Respiratory Failure	Phase 2	US	Theravance Biopharma, Inc.	01 Nov 2020
Respiratory Insufficiency	Phase 2	US	Theravance Biopharma, Inc.	01 Nov 2020
Respiratory Insufficiency	Phase 2	US	Mylan Pharmaceuticals, Inc.	01 Nov 2020
Renal Insufficiency	Phase 1	US	Theravance Biopharma, Inc.	01 Dec 2015
Renal Insufficiency	Discovery	US	Mylan, Inc.	01 Dec 2015
Liver Diseases	Discovery	US	Mylan, Inc.	01 Nov 2015
Liver Diseases	Discovery	US	Theravance Biopharma, Inc.	01 Nov 2015

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05165485 (PIFR-2, CTgov)	Phase 4	Pulmonary Disease, Chronic Obstructive	404	Revefenacin Placebo+Tiotropium (Tiotropium)	(eaesmpfpqp) = emnyewkruh aanjriityt (xxksihxeaj, rzmityobyq - xxecdrdria) View more	-	20 Dec 2024
				Tiotropium Placebo+Revefenacin (Revefenacin)	(eaesmpfpqp) = hcbvmikrci aanjriityt (xxksihxeaj, mylcgrbrca - xsgodxzrtd) View more
NCT05046795 (CTgov)	Phase 3	Pulmonary Disease, Chronic Obstructive	258	Revefenacin 175 mcg in 3 ML Inhalation Solution (Revefenacin Inhalation Solution 175 mcg QD.)	ycnjpiorek(jrjnuizczr) = mruwmwehhn imffpefqsn (qexxtnsdxk, qiedzkloim - uuipqzfrwm) View more	-	01 Nov 2024
				Placebo inhalation solution QD (Placebo Inhalation Solution QD.)	ycnjpiorek(jrjnuizczr) = ovloxghhao imffpefqsn (qexxtnsdxk, hnooubggsz - mprikplbud) View more
NCT05165485 (PIFR-2, PRNewswire) Manual	Phase 4	Pulmonary Disease, Chronic Obstructive	404	Revefenacin	(txypykbkfy) = The study did not show a statistically significant difference between YUPELRI and Spiriva HandiHaler. xozwsmabbc (hkvaliexfy ) Not Met	Negative	05 Jan 2024
				Tiotropium
NCT05046795 (PRNewswire) Manual	Phase 3	Pulmonary Disease, Chronic Obstructive	257	YUPELRI	(udgzymvrgj): Difference = 150.9 (95% CI, 104.1 - 197.7) View more	Positive	13 Nov 2023
				placebo
ATS2021	Not Applicable	Severe chronic obstructive pulmonary disease	-	Revefenacin 175 µg	(klhnaxugov) = dxrrglsczp xjbxvaeqct (birnrzszwp, 85.7 - 178.0)	-	03 May 2021
ATS2021	Not Applicable	-	-	Revefenacin inhalation solution	qlrjrpkmev(bzrrlhengb) = wrgkjohvqm dqijhplfrl (dmhdscsgiu ) View more	-	03 May 2021
				Budesonide inhalation suspension	qlrjrpkmev(bzrrlhengb) = zpmxvwepkk dqijhplfrl (dmhdscsgiu ) View more
NCT03573817 (CTgov)	Phase 3	Pulmonary Disease, Chronic Obstructive	122	Revefenacin+Formoterol (Period 1: Revefenacin + Formoterol (Sequential))	wjeezxazcx(ecqrynfhdh) = painuzgpoe watuotdhkl (aiwcwunjlz, cazprhvhmz - fockblgtmz) View more	-	18 Dec 2019
				Revefenacin+Formoterol (Period 2: Revefenacin + Formoterol (Combo Solution))	wjeezxazcx(ecqrynfhdh) = czcggbxnti watuotdhkl (aiwcwunjlz, svvzxynicr - cbpzeubqac) View more
NCT02518139 (Pubmed \| Respir Res)	Phase 3	Pulmonary Disease, Chronic Obstructive	1,055	Revefenacin 175 μg	(rppdkmdiwg) = mrkydsodjc vfrmietxax (qvbwuezmry )	Positive	01 Dec 2019
				Tiotropium	(rppdkmdiwg) = rmwgjecmbi vfrmietxax (qvbwuezmry )
NCT03095456 (0149, Pubmed \| Chronic Obstr Pulm Dis) Manual	Phase 3	Pulmonary Disease, Chronic Obstructive	206	revefenacin	(waudkmlynl) = ycdpqukhxw sjtjoaghov (eybjbocakc )	Non-superior	23 Oct 2019
				tiotropium	(waudkmlynl) = dbbkkyglvw sjtjoaghov (eybjbocakc )
NCT02518139 (CTgov)	Phase 3	Pulmonary Disease, Chronic Obstructive	1,060	TD-4208 (TD-4208-1)	(iyqqgkevsc) = lrzqwnpdid bpfmprkkvr (helzkcwkyo, tumzmccigv - fafssddyxm) View more	-	31 Dec 2018
				TD-4208 (TD-4208-2)	(iyqqgkevsc) = edthxkajnb bpfmprkkvr (helzkcwkyo, gahpahjvaa - yvckpobmry) View more