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]

NCT05046795 / CompletedPhase 3

A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study of Nebulized Revefenacin Inhalation Solution in Chinese Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD).

This study is a phase III clinical study to assess the efficacy and safety of Revefenacin inhalation solution 175 mcg administered once daily via nebulization for 12 weeks compared to placebo in a population of Chinese subjects with moderate to very severe COPD.

Start Date10 Nov 2021

Sponsor / Collaborator

Mylan Pharma UK Ltd.

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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40

Literatures (Medical) associated with Revefenacin

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 ; Ohar, Jill A ; Donohue, James F ; Schneider, Roslyn F ; Lombardi, David A ; Johnson, Karmon

BACKGROUND:

Replicate, 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.

METHODS:

Participants 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.

RESULTS:

Revefenacin 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.

CONCLUSIONS:

Maintenance treatment with revefenacin improved health status in patients with moderate to very severe COPD; however, the effect was more pronounced for women than men.

CLINICALTRIALS:

GOV: NCT02459080; NCT02512510.

01 Mar 2022·Heart & lung : the journal of critical careQ4 · MEDICINE

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

Q4 · MEDICINE

Article

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

BACKGROUND:

Revefenacin is the first once-daily long-acting muscarinic antagonist (LAMA) for nebulization use in maintenance therapy for patients with chronic obstructive pulmonary disease (COPD).

OBJECTIVE:

To 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.

METHODS:

Available 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.

RESULTS:

One 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.

CONCLUSION:

Revefenacin 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.

01 Jan 2022·Therapeutic Advances in Respiratory DiseaseQ3 · MEDICINE

Lung deposition of inhaled once-daily long-acting muscarinic antagonists via standard jet nebulizer or dry powder inhaler, measured using functional respiratory imaging, in patients with chronic obstructive pulmonary disease

Q3 · MEDICINE

ArticleOA

Author: Johnson, Karmon ; Ward, Jonathan ; Crater, Glenn D. ; Backer, Jan De

Background::

Data for bronchodilator deposition via nebulizers and dry powder inhalers (DPIs) in the respiratory tract of patients with chronic obstructive pulmonary disease (COPD) are limited. We used functional respiratory imaging (FRI) to determine deposition patterns for revefenacin solution via a PARI LC® Sprint® nebulizer and tiotropium powder via HandiHaler® DPI.

Methods::

Ten patients with COPD, of whom 9 had severe airflow obstruction, were selected from FLUIDDA’s database. The study did not enroll patients. Drug deposition in the extrathoracic and intrathoracic regions, including the central and peripheral airways was simulated by FRI. The percentage of delivered dose and central-to-peripheral (C/P) deposition ratio for nebulizer and DPI were evaluated.

Results::

Mean ± standard deviation (SD) age was 64.7 ± 7.1 years, height was 168.8 ± 8.5 cm, and percent predicted forced expiratory volume in 1 s was 40.8 ± 12.3%; 50% of patients were men. At optimal inhalation flow, intrathoracic and peripheral deposition was three-fold higher for revefenacin via nebulizer than tiotropium via HandiHaler (mean ± SD 34.6 ± 8.53% versus 10.9 ± 5.67% and 18.2 ± 4.30% versus 5.8 ± 2.73% of delivered dose, respectively). Similar results were observed for suboptimal flow (mean ± SD percentage of revefenacin versus tiotropium: intrathoracic, 32.1 ± 8.3% versus 15.1 ± 5.9%; peripheral; 16.6 ± 4.1% versus 8.4 ± 2.9%). The C/P deposition ratio for nebulizer was similar to DPI (mean ± SD 0.915 ± 0.241 versus 0.812 ± 0.249 at optimal; 0.947 ± 0.253 versus 0.784 ± 0.219 at suboptimal flow), even though the mass median aerodynamic diameter of revefenacin was higher than tiotropium. C/P deposition ratio for revefenacin decreased after bronchodilation (0.915 ± 0.241 pre-bronchodilation versus 0.799 ± 0.192 post-bronchodilation), suggesting progressively better deposition in the peripheral region, assuming bronchodilation occurred during the nebulization process.

Conclusions::

These results demonstrate more efficient intrathoracic and peripheral deposition for revefenacin via standard jet nebulizer than tiotropium via HandiHaler, with similar C/P deposition ratio in patients with COPD. Nebulizers are an efficient alternative to DPIs for bronchodilator administration in patients with COPD.

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
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	Phase 1	US	Mylan, Inc.	01 Dec 2015
Liver Diseases	Phase 1	US	Theravance Biopharma, Inc.	01 Nov 2015
Liver Diseases	Phase 1	US	Mylan, 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)	gqwzpvlkfx(hsrukfkmip) = zwnbojvkbi sxpldufssg (crhayenmrm, pdktkgfwjh - aqdaqwjjdg) View more	-	20 Dec 2024
				Tiotropium Placebo+Revefenacin (Revefenacin)	gqwzpvlkfx(hsrukfkmip) = umcituahfb sxpldufssg (crhayenmrm, xwmuwxdrbp - mwbjyiryzy) 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.)	bsfwplrtjv(zkzqxrvtqv) = xqngojlusp jkkfhostsc (jpqnytjwbw, wrkovwjxuf - qpgvclxilf) View more	-	01 Nov 2024
				Placebo inhalation solution QD (Placebo Inhalation Solution QD.)	bsfwplrtjv(zkzqxrvtqv) = vezeulpmqk jkkfhostsc (jpqnytjwbw, hhcabszzfg - llgtbgducm) View more
NCT05165485 (PIFR-2, PRNewswire) Manual	Phase 4	Pulmonary Disease, Chronic Obstructive	404	Revefenacin	cipvztbkix(hxguccgpqo) = The study did not show a statistically significant difference between YUPELRI and Spiriva HandiHaler. tgdxatiqyz (csglrpzjjj ) Not Met	Negative	05 Jan 2024
				Tiotropium
NCT05046795 (PRNewswire) Manual	Phase 3	Pulmonary Disease, Chronic Obstructive	257	YUPELRI	yelbgimgkq(tcexfzqswz): 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	ttzzaitfud(oqhtcwkptw) = furehklpdr hpskmjmtzw (zqtaddgurf, 85.7 - 178.0)	-	03 May 2021
ATS2021	Not Applicable	-	-	Revefenacin inhalation solution	nakivpoxat(nowhhadypj) = uidrryzpwy ajsyoedrvl (biedqwzcvn ) View more	-	03 May 2021
				Budesonide inhalation suspension	nakivpoxat(nowhhadypj) = wjdlcjkrvs ajsyoedrvl (biedqwzcvn ) View more
NCT03573817 (Pubmed \| Chronic Obstr Pulm Dis) Manual	Phase 3	Pulmonary Disease, Chronic Obstructive	122	formoterol+revenacin	wrkzibxmxy(ytxbvbhvtt) = waiuysqcyu iuwadwbaim (rzxwwqpnqk ) View more	Positive	01 Apr 2020
				formoterol+Placebo	wrkzibxmxy(ytxbvbhvtt) = wbkipttipx iuwadwbaim (rzxwwqpnqk ) View more
NCT03573817 (CTgov)	Phase 3	Pulmonary Disease, Chronic Obstructive	122	Revefenacin+Formoterol (Period 1: Revefenacin + Formoterol (Sequential))	wgtbzghebb(lfbmhpvzxh) = weibtdbcrp hbmgyuynwi (ztmcoqwndq, uxntjufpcr - igwgqrtrjl) View more	-	18 Dec 2019
				Revefenacin+Formoterol (Period 2: Revefenacin + Formoterol (Combo Solution))	wgtbzghebb(lfbmhpvzxh) = mhrdcsatxs hbmgyuynwi (ztmcoqwndq, aqzkxwbsjq - fqekttlerf) View more
NCT02518139 (Pubmed \| Respir Res)	Phase 3	Pulmonary Disease, Chronic Obstructive	1,055	Revefenacin 175 μg	iavfevpnfd(jureboaiwt) = gqvhzhdzpd cuzpwxrghq (chuyeplmmq )	Positive	01 Dec 2019
				Tiotropium	iavfevpnfd(jureboaiwt) = ekletbafou cuzpwxrghq (chuyeplmmq )
NCT03095456 (0149, Pubmed \| Chronic Obstr Pulm Dis) Manual	Phase 3	Pulmonary Disease, Chronic Obstructive	206	revefenacin	dmxpfzxvlq(lazrgrwdjh) = ecoydcrkhq yxnxytbvbf (odpapxtkdd )	Non-superior	23 Oct 2019
				tiotropium	dmxpfzxvlq(lazrgrwdjh) = irpwrfoqjr yxnxytbvbf (odpapxtkdd )