The NODE-202 Study Multi-Center, Multi-National, Open-Label, Efficacy and Safety Study of Etripamil Nasal Spray in Pediatric Patients With Paroxysmal Supraventricular Tachycardia

NODE-202 is a Phase 2, multicenter, multinational, single dose, open-label, 2-part, sequential design study in pediatric patients with an established diagnosis of paroxysmal supraventricular tachycardia (PSVT) presenting with a symptomatic episode of PSVT.
In Part 1, at least 30 patients aged 12 to <18 years will be enrolled and treated with etripamil nasal spray (NS). Efficacy, safety, tolerability and PK (for at least 12 patients) will be assessed after administration of 70 mg etripamil NS (Part 1A). At least 18 subsequent patients will be enrolled and treated with the etripamil NS with the dose determined by the Pharmacokinetic (PK) analysis and will undergo efficacy and safety/tolerability assessments (Part 1B).
In Part 2, at least 30 patients aged 6 to <12 years will be enrolled and treated with etripamil NS at a dose selected based on appropriate body size-based modeling, as well as efficacy, safety/tolerability, and PK data collected in Part 1. Efficacy, safety, tolerability and PK (for at least 12 patients) will be assessed after administration of etripamil NS (Part 2A). At least 18 subsequent patients will be enrolled and treated with the etripamil NS with the dose determined by the PK analysis and will undergo efficacy and safety/tolerability assessments (Part 2B).
The study will include the following visits: A Screening Visit, A Treatment Visit, , and A Follow-Up/End of Study Visit.

Start Date11 Dec 2023

Sponsor / Collaborator

Milestone Pharmaceuticals, Inc.

CTR20221959 / CompletedPhase 1

一项在中国健康受试者中评价Etripamil药代动力学、药效学、安全性和耐受性的单中心、随机、双盲、安慰剂对照1期临床研究

[Translation] A single-center, randomized, double-blind, placebo-controlled phase 1 clinical study to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of Etripamil in healthy Chinese subjects

主要目的： · 在中国健康成年受试者中评价Etripamil的药代动力学（PK）次要目的： · 在中国健康成年受试者中评价Etripamil的药效学（PD） · 在中国健康成年受试者中评价Etripamil的安全性和耐受性探索性目的： · 在中国健康成年受试者中评价Etripamil的PK（暴露）-PD（效应）关系

[Translation]

Primary objective: · To evaluate the pharmacokinetics (PK) of Etripamil in healthy Chinese adult subjects Secondary objective: · To evaluate the pharmacodynamics (PD) of Etripamil in healthy Chinese adult subjects · To evaluate the safety and tolerability of Etripamil in healthy Chinese adult subjects Exploratory objective: · To evaluate the PK (exposure)-PD (effect) relationship of Etripamil in healthy Chinese adult subjects

Start Date07 Mar 2023

Sponsor / Collaborator

Milestone Pharmaceuticals, Inc.

[+2]

NCT05511870 / CompletedPhase 1

A Single Center, Randomized, Double-Blind, Placebo-Controlled Phase 1 Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Etripamil in Healthy Chinese Subjects

The objectives of the study are as below:
Primary:
·To evaluate the pharmacokinetics (PK) of Etripamil in healthy adult Chinese subjects
Secondary:
To evaluate the pharmacodynamics (PD) of Etripamil in healthy adult Chinese subjects
To evaluate the safety and tolerability of Etripamil in healthy adult Chinese subjects
Exploratory:
·To evaluate the PK exposure-PD response relationship of etripamil in healthy adult Chinese subjects

Start Date07 Mar 2023

Sponsor / Collaborator

Ji Xing Pharmaceuticals Co., Ltd.

[+1]

100 Clinical Results associated with Etripamil

100 Translational Medicine associated with Etripamil

100 Patents (Medical) associated with Etripamil

Literatures (Medical) associated with Etripamil

01 Apr 2024·American heart journal

Rationale and design of the NODE-303 study: evaluating the safety of symptom-prompted, self-administered etripamil for paroxysmal supraventricular tachycardia episodes in real-world settings

Article

Author: Stambler, Bruce ; Uribe, Juan Agudelo ; Vyselaar, John ; Camm, A John ; Sears, Samuel F ; Shardonofsky, Silvia ; Omodele, Sarah ; Noseworthy, Peter A ; Bharucha, David B ; Bui, Hanh ; Ip, James E ; Coutu, Benoit ; Parody, Maria Leonor ; Singh, Narendra

BACKGROUND:

Paroxysmal supraventricular tachycardia (PSVT) is a common episodic arrhythmia characterized by unpredictable onset and burdensome symptoms including palpitations, dizziness, chest pain, distress, and shortness of breath. Treatment of acute episodes of PSVT in the clinical setting consists of intravenous adenosine, beta-blockers, and calcium channel blockers (CCBs). Etripamil is an intranasally self-administered L-type CCB in development for acute treatment of AV-nodal dependent PSVT in a nonmedical supervised setting.

METHODS:

This paper summarizes the rationale and study design of NODE-303 that will assess the efficacy and safety of etripamil. In the randomized, double-blinded, placebo-controlled, Phase 3 RAPID trial, etripamil was superior to placebo in the conversion of single PSVT episodes by 30 minutes post initial dose when administered in the nonhealthcare setting; this study required a mandatory and observed test dosing prior to randomization. The primary objective of NODE-303 is to evaluate the safety of symptom-prompted, self-administered etripamil for multiple PSVT episodes in real-world settings, without the need for test dosing prior to first use during PSVT. Secondary endpoints include efficacy and disease burden. Upon perceiving a PSVT episode, the patient applies an electrocardiographic monitor, performs a vagal maneuver, and, if the vagal maneuver is unsuccessful, self-administers etripamil 70 mg, with an optional repeat dose if symptoms do not resolve within 10 minutes after the first dose. A patient may treat up to four PSVT episodes during the study. Adverse events are recorded as treatment-emergent if they occur within 24 hours after the administration of etripamil.

RESULTS:

Efficacy endpoints include time to conversion to sinus rhythm within 30 and 60 minutes after etripamil administration, and the proportion of patients who convert at 3, 5, 10, 20, 30, and 60 minutes. Patient-reported outcomes are captured by the Brief Illness Perception Questionnaire, the Cardiac Anxiety Questionnaire, the Short Form Health Survey 36, the Treatment Satisfaction Questionnaire for Medication and a PSVT survey.

CONCLUSIONS:

Overall, these data will support the development of a potentially paradigm-changing long-term management strategy for recurrent PSVT.

01 Dec 2023·Circulation. Arrhythmia and electrophysiology

Multicenter, Phase 2, Randomized Controlled Study of the Efficacy and Safety of Etripamil Nasal Spray for the Acute Reduction of Rapid Ventricular Rate in Patients With Symptomatic Atrial Fibrillation (ReVeRA-201)

Article

Author: Gosselin, Gilbert ; Thermil, Nathalie ; Mondésert, Blandine ; Guertin, Marie-Claude ; Camm, A John ; Kowey, Peter R ; Shardonofsky, Silvia ; Ip, James E ; Dorian, Paul ; Piccini, Jonathan P ; Alings, Marco ; Bharucha, David B ; Prins, Fransisco J ; Al Windy, Nadea ; van Eck, Jwm ; Stambler, Bruce S ; Roy, Denis ; Roux, Jean-Francois

BACKGROUND::

Despite chronic therapies, atrial fibrillation (AF) leads to rapid ventricular rates (RVR) often requiring intravenous treatments. Etripamil is a fast-acting, calcium-channel blocker administered intranasally affecting the atrioventricular node within minutes.

METHODS::

Reduction of Ventricular Rate in Patients with Atrial Fibrillation evaluated the efficacy and safety of etripamil for the reduction of ventricular rate (VR) in patients presenting urgently with AF-RVR (VR ≥110 beats per minute [bpm]), was randomized, double-blind, placebo-controlled, and conducted in Canada and the Netherlands. Patients presenting urgently with AF-RVR were randomized (1:1, etripamil nasal spray 70 mg: placebo nasal spray). The primary objective was to demonstrate the effectiveness of etripamil in reducing VR in AF-RVR within 60 minutes of treatment. Secondary objectives assessed achievement of VR <100 bpm, reduction by ≥10% and ≥20%, relief of symptoms and treatment effectiveness; adverse events; and additional measures to 360 minutes.

RESULTS::

Sixty-nine patients were randomized, 56 dosed with etripamil (n=27) or placebo (n=29). The median age was 65 years; 39% were female patients; proportions of AF types were similar between groups. The difference of mean maximum reductions in VR over 60 minutes, etripamil versus placebo, adjusting for baseline VR, was −29.91 bpm (95% CI, −40.31 to −19.52; P <0.0001). VR reductions persisted up to 150 minutes. Significantly greater proportions of patients receiving etripamil achieved VR reductions <100 bpm (with longer median duration <100 bpm), or VR reduction by ≥10% or ≥20%, versus placebo. VR reduction ≥20% occurred in 66.7% of patients in the etripamil arm and no patients in placebo. Using the Treatment Satisfaction Questionnaire for Medication-9, there was significant improvement in satisfaction on symptom relief and treatment effectiveness with etripamil versus placebo. Serious adverse events were rare; 1 patient in the etripamil arm experienced transient severe bradycardia and syncope, assessed as due to hypervagotonia.

CONCLUSIONS::

Intranasal etripamil 70 mg reduced VR and improved symptom relief and treatment satisfaction. These data support further development of self-administered etripamil for the treatment of AF-RVR.

REGISTRATION::

URL: https://www.clinicaltrials.gov ; Unique Identifier: NCT04467905

01 Dec 2023·Cardiology and therapy

Podcast on Self-administered Intranasal Etripamil for Symptomatic Paroxysmal Supraventricular Tachycardia: The RAPID Trial

Letter

Author: Stambler, Bruce S ; Ip, James E

Paroxysmal supraventricular tachycardia (PSVT) is commonly seen in clinical practice and represents a significant burden to the healthcare system and to patients. First-line treatments include calcium channel blockers (CCB), although they are intravenous and require medical supervision. Etripamil is an investigational self-administered intranasal L-type CCB for unsupervised treatment of PSVT. In this podcast, we discuss the RAPID trial (NCT03464019), which was a phase 3 study that evaluated the safety and efficacy of etripamil in terminating PSVT episodes using a repeat-dosing regimen. RAPID was a multicenter, randomized trial that enrolled adults with electrocardiograph (ECG)-documented PSVT episodes lasting ≥ 20 min. Patients who tolerated test doses of etripamil were randomized 1:1 to receive either etripamil or placebo. Upon perceiving PSVT symptoms, patients began ECG monitoring and performed a vagal maneuver. If arrhythmia termination was unsuccessful, they self-administered 70 mg of etripamil or placebo, followed by an optional second dose after 10 min. The primary endpoint was time to conversion of PSVT to sinus rhythm within 30 min of the initial dose and sustained for ≥ 30 s. The safety group included all patients who self-administered the study treatment. Of 692 enrollees, 184 self-administered the study drug (99 etripamil, 85 placebo) for ECG-confirmed PSVT. Conversion of PSVT to sinus rhythm within 30 min was achieved in 64.3% of etripamil-treated subjects versus 31.2% of placebo-treated subjects. A significant threefold reduction in the median time to conversion of 17.2 min was observed in the etripamil group versus 53.5 min in the placebo group. Treatment-emergent adverse events were mild or moderate and primarily included transient nasal discomfort, nasal congestion, and rhinorrhea. If etripamil is approved by the US FDA, it can potentially address a significant unmet need for PSVT treatment outside a clinical setting, reducing the need for intravenous treatments that require medical supervision.Podcast available for this article.

News (Medical) associated with Etripamil

12 Jun 2024

·www.globenewswire.com

Milestone Pharmaceuticals to Host KOL Event for Investors “Learnings from the Field: Expert Perspectives on PSVT in the Community Setting” on June 20, 2024

MONTREAL and CHARLOTTE, N.C., June 12, 2024 (GLOBE NEWSWIRE) -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that it will host Part I of its virtual investor educational series on Thursday, June 20, 2024, at 8:00 AM ET. To register for “Learnings from the Field: Expert Perspectives on Managing PSVT in the Community Setting,” click here. The event will feature George Mark, MD, FACC and Vivek Sailam, MD from The Heart House and Cooper University Health Care, who will discuss the burden of paroxysmal supraventricular tachycardia (PSVT) on patients and their practice, current treatments and unmet needs, and expectations for how the treatment landscape will evolve in coming years. A live question and answer session will follow the formal presentation. About George Mark, MD, FACC George Mark, MD, FACC is a cardiac electrophysiologist at The Heart House and Cooper University Health Care who specializes in treating rhythm disorders of the heart. His practice includes medical device implantation for the prevention of sudden cardiac death and cardiac ablation to treat abnormal heart rhythms. Dr. Mark graduated from Wesleyan University with a degree in Molecular Biology and Biochemistry and received his medical degree from Temple University. Dr. Mark remained at Temple for his residency in Internal Medicine, where he served for a year as Chief Medical Resident. Dr. Mark completed his fellowship training in Cardiovascular Diseases and Clinical Cardiac Electrophysiology at Thomas Jefferson University Hospital. About Vivek Sailam, MDVivek Sailam, MD is a clinical cardiologist at The Heart House and Cooper University Health Care with more than 16 years of experience. He completed his internal Medicine Residency at Hahnemann University and pursued additional training in cardiovascular disease. His dedication and expertise have been acknowledged with awards such as South Jersey Top Docs, Guardian Angel Award, and NJ Top Docs. Dr. Sailam has contributed to the medical field through publications in the NY Times 2021. Beyond medicine, Dr. Sailam is passionate about Community Health programs: "Walk with a Doc, Workout with a Doc, Eat with a Doc, Shop with a Doc," nutrition, fitness, and racing automobiles, finding his balance and inspiration outside the clinic or hospital. About Paroxysmal Supraventricular Tachycardia An estimated two million people in the United States are currently diagnosed with PSVT which is a type of arrhythmia or abnormal heart rhythm. PSVT is characterized by episodes of sudden onset rapid heartbeats often exceeding 150 to 200 beats per minute. The heart rate spike is unpredictable and may last several hours. The rapid heart rate often causes disabling severe palpitations, shortness of breath, chest discomfort, dizziness or lightheadedness, and distress, forcing patients to limit their daily activities. The uncertainty of when an episode of PSVT will strike or how long it will persist can provoke anxiety in patients and negatively impact their day-to-day life between episodes. The impact and morbidity from an attack can be especially detrimental in patients with underlying cardiovascular or medical conditions, such as heart failure, obstructive coronary disease, or dehydration. Many health care providers are dissatisfied with the lack of effective treatment options with patients often requiring prolonged, burdensome, and costly trips to the emergency department or even invasive cardiac ablation procedures. About Milestone Pharmaceuticals Milestone Pharmaceuticals Inc. (Nasdaq: MIST) is a biopharmaceutical company developing and commercializing innovative cardiovascular solutions to improve the lives of people living with complex and life-altering heart conditions. The Company’s focus on understanding unmet patient needs and improving the patient experience has led us to develop new treatment approaches that provide patients with an active role in self-managing their care. Milestone’s lead investigational product is CARDAMYST (etripamil) nasal spray, a novel calcium channel blocker that is being studied for patients to self-administer without medical supervision to treat symptomatic episodic attacks associated with PSVT and AFib-RVR. Contact: Kim Fox, Vice President, Communications, kfox@milestonepharma.com Investor Relations Chris Calabrese, ccalabrese@lifesciadvisors.com Kevin Gardner, kgardner@lifesciadvisors.com Source: Milestone Pharmaceuticals Inc.

Executive Change

31 May 2024

·www.globenewswire.com

Milestone® Pharmaceuticals to Participate in the Upcoming Jefferies Global Healthcare Conference

MONTREAL and CHARLOTTE, N.C., May 31, 2024 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST) today announced that members of its management team will participate in the Jefferies Global Healthcare Conference being held in New York City, NY from June 4-6, 2024. Management will participate in a Fireside Chat on June 6th at 11:30 AM EDT. The webcast is available to watch both live and replay for approximately 90 days following the presentation in the News & Events section of Milestone's website www.milestonepharma.com. About Milestone Pharmaceuticals Milestone Pharmaceuticals Inc. (Nasdaq: MIST) is a biopharmaceutical company developing and commercializing innovative cardiovascular solutions to improve the lives of people living with complex and life-altering heart conditions. The Company’s focus on understanding unmet patient needs and improving the patient experience has led us to develop new treatment approaches that provide patients with an active role in self-managing their care. Milestone's lead investigational product is etripamil, a novel calcium channel blocker nasal spray that is being studied for patients to self-administer without medical supervision to treat symptomatic episodic attacks associated with PSVT and AFib-RVR. Contact: Kim Fox, Vice President, Communications, kfox@milestonepharma.com Investor Relations Chris Calabrese, ccalabrese@lifesciadvisors.com Kevin Gardner, kgardner@lifesciadvisors.com

AHA

29 May 2024

·www.globenewswire.com

Milestone Pharmaceuticals Announces FDA Acceptance of New Drug Application for CARDAMYST™

MONTREAL and CHARLOTTE, N.C., May 29, 2024 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that the United States Food and Drug Administration (FDA) accepted the Company’s New Drug Application (NDA) on May 26, 2024 for CARDAMYST (etripamil) nasal spray, its lead investigational product for the management of paroxysmal supraventricular tachycardia (PSVT). The FDA Prescription Drug User Fee Act (PDUFA) target date is 10 months from the acceptance date of May 26, 2024. “The FDA’s acceptance of our NDA for CARDAMYST brings Milestone one step closer in our mission in providing a new, convenient and effective treatment option for patients with PSVT,” said Joseph Oliveto, President, and Chief Executive Officer of Milestone Pharmaceuticals. “We understand the frequent impact that PSVT has on patients, as well as the underappreciated burden it places on their families and caregivers. Our progress toward providing a sense of security for patients is a result of the dedicated Milestone team, patients, and investigators to whom we are thankful.” The CARDAMYST clinical trial program represents the largest data package ever studied for an acute drug treatment intended for patient self-management of PSVT events. Milestone continues to advance commercial preparations to support the anticipated launch of etripamil with the proposed trade name, CARDAMYST. The brand name is conditionally approved by the FDA. About Paroxysmal Supraventricular Tachycardia An estimated two million people in the United States are currently diagnosed with PSVT which is a type of arrhythmia or abnormal heart rhythm. PSVT is characterized by episodes of sudden onset rapid heartbeats often exceeding 150 to 200 beats per minute. The heart rate spike is unpredictable and may last several hours. The rapid heart rate often causes disabling severe palpitations, shortness of breath, chest discomfort, dizziness or lightheadedness, and distress, forcing patients to limit their daily activities. The uncertainty of when an episode of PSVT will strike or how long it will persist can provoke anxiety in patients and negatively impact their day-to-day life between episodes. The impact and morbidity from an attack can be especially detrimental in patients with underlying cardiovascular or medical conditions, such as heart failure, obstructive coronary disease, or dehydration. Many health care providers are dissatisfied with the lack of effective treatment options with patients often requiring prolonged, burdensome, and costly trips to the emergency department or even invasive cardiac ablation procedures. About CARDAMYST (etripamil) nasal spray CARDAMYST is Milestone’s lead investigational product. It is a novel calcium channel blocker nasal spray under clinical development for frequent and often highly symptomatic episodes of PSVT and AFib-RVR. It is designed as a self-administered rapid response therapy for patients thereby bypassing the need for immediate medical oversight. If approved, etripamil is intended to provide health care providers with a new treatment option to enable on-demand care and patient self-management. This portable, self-administered treatment may provide patients with active management and a greater sense of control over their condition. The clinical trial program for CARDAMYST includes a completed Phase 3 clinical-stage program for the treatment of PSVT and Phase 2 trial for the treatment of patients with AFib-RVR. About Milestone Pharmaceuticals Milestone Pharmaceuticals Inc. (Nasdaq: MIST) is a biopharmaceutical company developing and commercializing innovative cardiovascular solutions to improve the lives of people living with complex and life-altering heart conditions. The Company’s focus on understanding unmet patient needs and improving the patient experience has led us to develop new treatment approaches that provide patients with an active role in self-managing their care. Milestone’s lead investigational product is CARDAMYST (etripamil) nasal spray, a novel calcium channel blocker that is being studied for patients to self-administer without medical supervision to treat symptomatic episodic attacks associated with PSVT and AFib-RVR. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “continue,” “could,” “demonstrate,” “designed,” “develop,” “estimate,” “expect,” “may,” “pending,” “plan,” “potential,” “progress,” “will,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Milestone’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding our ability to bring a new PSVT therapeutic option to market; the timing and outcomes of future interactions with U.S. and foreign regulatory bodies, including the FDA; the timing of the launch of etripamil; and our ability to advance commercial preparations to support the anticipated launch of etripamil. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to, whether our future interactions with the FDA will have satisfactory outcomes; the risks inherent in biopharmaceutical product development and clinical trials, including the lengthy and uncertain regulatory approval process; uncertainties related to the timing of initiation, enrollment, completion, evaluation and results of our clinical trials; risks and uncertainty related to the complexity inherent in cleaning, verifying and analyzing trial data; and whether the clinical trials will validate the safety and efficacy of etripamil for PSVT or other indications, among others, general economic, political, and market conditions, including deteriorating market conditions due to investor concerns regarding inflation, Russian hostilities in Ukraine and ongoing disputes in Israel and Gaza and overall fluctuations in the financial markets in the United States and abroad, risks related to pandemics and public health emergencies, and risks related the sufficiency of Milestone’s capital resources and its ability to raise additional capital in the current economic climate. These and other risks are set forth in Milestone’s filings with the U.S. Securities and Exchange Commission, including in its annual report on Form 10-K for the year ended December 31, 2023, under the caption “Risk Factors,” as such discussion may be updated from time to time by subsequent filings Milestone may make with the U.S. Securities & Exchange Commission. Except as required by law, Milestone assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available. Contact: Kim Fox, Vice President, Communications, kfox@milestonepharma.com Investor Relations Chris Calabrese, ccalabrese@lifesciadvisors.com Kevin Gardner, kgardner@lifesciadvisors.com

NDAPhase 3Phase 2

100 Deals associated with Etripamil

External Link

KEGG	Wiki	ATC	Drug Bank
D10932	-	-	DB12605

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Paroxysmal supraventricular tachycardia	NDA/BLA	US	Milestone Pharmaceuticals, Inc.	26 Feb 2024
Tachycardia, Supraventricular	Phase 3	CN	Ji Xing Pharmaceuticals Co., Ltd.	30 Jun 2022
Atrial Fibrillation	Phase 2	US	Milestone Pharmaceuticals, Inc.	30 Oct 2020
Atrial Fibrillation	Phase 2	CA	Milestone Pharmaceuticals, Inc.	30 Oct 2020

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04072835 (NODE-303, CTgov)	Phase 3	Paroxysmal supraventricular tachycardia	1,116	etripamil NS	agrbjvnjtf(ddozzwgpyw) = bxsfpcoyye fzedflorhe (ygqqqmmgub, vzmmgnwwal - ygnufangzm) View more	-	23 May 2024
NCT03464019 (RAPID, Pubmed)	Phase 3	Tachycardia, Atrioventricular Nodal Reentry	692	Etripamil 70 mg nasal spray	ntuilsgbel(hqbsypnzyr) = Adverse events occurring in at least 5% of patients treated with etripamil were nasal discomfort (23%), nasal congestion (13%), and rhinorrhea (9%) uhqtdyomhb (xizxkaqaze ) View more	Positive	15 Jun 2023
				Placebo
NCT03635996 (CTgov)	Phase 3	Paroxysmal supraventricular tachycardia	169	Aptar Pharma Nasal Spray Bidose System+Etripamil NS 70 mg	bjqmwjodyj(rysquljwvy) = yokbfancjy foqwpkmpdj (thekxrrykp, xkssrhlfuk - gmgjgvjlju) View more	-	24 Apr 2023
NCT03464019 (NODE-301, Pubmed) Manual	Phase 3	Paroxysmal supraventricular tachycardia	156	Etripamil	nldlmclczh(pxaxlbspnq): HR = 1.086 (95% CI, 0.726 - 1.623), P-Value = 0.12	Negative	28 Nov 2022
				Placebo
NCT03464019 (RAPID, Corporate Publications) Manual	Phase 3	Paroxysmal supraventricular tachycardia	706	Etripamil	eemfbeeiqc(mvhxenzkhc) = yccaqzdoyw lqromenfjg (uepnmtmzcr ) View more	Positive	17 Oct 2022
				Placebo	eemfbeeiqc(mvhxenzkhc) = ejkqnjlplg lqromenfjg (uepnmtmzcr ) View more
NCT02296190 (NODE-1, CTgov)	Phase 2	Paroxysmal supraventricular tachycardia	199	Placebo	ztymwfxctk(iuxeyvwfue) = jatjiesbrg gtozwrsnpa (ngvrbzfxjd, xkknumnhjc - wtsvfvhfuz) View more	-	30 Dec 2020
NCT03464019 (NODE-301, Corporate Publications) Manual	Phase 3	Paroxysmal supraventricular tachycardia	431	Etripamil	dapctgswsk(awlacxnvco) = ruczumltvh vvwsccnqyo (eswljodcad, 16 ~ 43) View more	Negative	23 Mar 2020
				Placebo	dapctgswsk(awlacxnvco) = pskqepcdqi vvwsccnqyo (eswljodcad, 31 ~ 101) View more
NCT02296190 (NODE-1, Pubmed) Manual	Phase 2	Tachycardia, Supraventricular	104	MSP-2017	kqoghfnbfu(rsfamelxww) = iacvukgrio ujmfcabrzm (tffgtzkien )	Positive	31 Jul 2018
				Placebo	kqoghfnbfu(rsfamelxww) = ilzzqlbbtp ujmfcabrzm (tffgtzkien )

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