Delving into the Latest Updates on Zuranolone with Synapse

The goal of this Phase II clinical trial is to learn if the oral synthetic allopreganolone analog (zuranolone) is safe to take and is well tolerated by stroke survivors experiencing moderate to severe post-stroke depression and if it will help with the symptoms of depression. The main questions it will aim to answer are:
* Is zuranolone safe to take by participants who have moderate to severe post-stroke depression?
* Is zuranolone well-tolerated by participants who have moderate to severe post-stroke depression?
* Does zuranolone treat moderate to severe post-stroke depression?
The study will enroll six participants. All participants will be given 50 mg of zuranolone for 14 days.
Participants will be asked to provide blood samples, complete some questionnaires including those related to mood and a cognitive assessment.

Start Date01 Apr 2025

Sponsor / Collaborator

Duke University

[+1]

NCT05655507

/ CompletedPhase 1

A Phase 1, Study to Evaluate the Pharmacokinetics and Safety of Zuranolone in Adolescents (12 to 17 Years of Age) With Major Depressive Disorder

The primary purpose of this study is to evaluate the pharmacokinetics and safety of Zuranolone in adolescents (ages 12 to 17 years) with MDD.

Start Date19 Apr 2023

Sponsor / Collaborator

SAGE Therapeutics, Inc.

[+1]

JPRN-jRCT2031220423

/ Not yet recruitingPhase 3IIT

A phase 3 study of S-812217 in combination with an antidepressant in patients with major depressive disorder consisting of randomized, double-blind, placebo-control part and extension, open-label, re-treatment part

Start Date01 Nov 2022

Sponsor / Collaborator-

100 Clinical Results associated with Zuranolone

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100 Translational Medicine associated with Zuranolone

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100 Patents (Medical) associated with Zuranolone

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98

Literatures (Medical) associated with Zuranolone

31 Dec 2024·Journal of medical economics

The cost-effectiveness of zuranolone versus selective serotonin reuptake inhibitors for the treatment of postpartum depression in the United States

Article

Author: Deligiannidis, Kristina M. ; O’Callaghan, Lasair ; Chertavian, Elizabeth ; Ferries, Erin ; Johnson, Scott J.

AIMS:

The objective of this research is to evaluate the cost-effectiveness of zuranolone, the first oral treatment indicated for postpartum depression (PPD) in adults approved by the United States Food and Drug Administration.

METHODS:

Zuranolone and selective serotonin reuptake inhibitor (SSRI) trial-based efficacy was derived from an indirect treatment comparison. Long-term efficacy outcomes were based on a large longitudinal cohort study. Maternal health utility values were derived from trial-based, short-form 6-D responses. Other inputs were derived from literature and economic data from the US Bureau of Labor Statistics. We estimated costs (2023 US dollars) and quality-adjusted life-years (QALYs) for patients with PPD treated with zuranolone (14-day dosing) or SSRIs (chronic dosing). The indirect costs and QALYs of the children and partners were also estimated.

RESULTS:

The incremental cost-effectiveness ratio for zuranolone versus SSRIs was $94,741 per QALY gained over an 11-year time horizon. Maternal total direct medical costs averaged $84,318 in the zuranolone arm, compared to $86,365 in the SSRI arm. Zuranolone-treated adults averaged 6.178 QALYs compared to 6.116 QALYs for the SSRI arm. Costs and utilities for the child and partner were also included in the base case. Drug and administration costs for zuranolone averaged $15,902, compared to $30 for SSRIs over the studied time horizon. Results were sensitive to the model time horizon.

LIMITATIONS:

As head-to-head trials were not available to permit direct comparison, efficacy inputs were derived from an indirect treatment comparison which can be confounded by cross-trial differences. The data used are reflective of a general PPD population rather than marginalized individuals who may be at a greater risk for adverse PPD outcomes. The model likely excludes unmeasured effects for patient, child, and partner.

CONCLUSIONS:

This economic model's results suggest that zuranolone is a more cost-effective therapy compared to SSRIs for treating adults with PPD.

31 Dec 2024·Journal of medical economics

Indirect comparisons of relative efficacy estimates of zuranolone and selective serotonin reuptake inhibitors for postpartum depression

Review

Author: Roskell, Neil ; Smith, Sarah ; Toubouti, Youssef ; Deligiannidis, Kristina M ; Tan, Robin ; Mak, Catherine ; Gerbasi, Margaret E ; Chen, Shih-Yin Sharon ; Meltzer-Brody, Samantha

AIMS:

Estimate relative efficacy of zuranolone, a novel oral, Food and Drug Administration-approved treatment for postpartum depression (PPD) in adults vs. selective serotonin reuptake inhibitors (SSRIs) and combination therapies used for PPD in the United States.

MATERIALS AND METHODS:

Randomized controlled trials (RCTs) for zuranolone and SSRIs, identified from systematic review, were used to construct evidence networks, linking via common comparator arms. Due to heterogeneity in placebo responses, matching-adjusted indirect comparison (MAIC) was applied, statistically weighting the zuranolone treatment arm of Phase 3 SKYLARK Study (NCT04442503) to the placebo arm of RCTs investigating SSRIs for PPD. MAIC outputs were applied in Bucher indirect treatment comparisons (ITCs) and network meta-analysis (NMA), using Edinburgh Postnatal Depression Scale (EPDS) and 17-item Hamilton Rating Scale for Depression (HAMD-17) change from baseline (CFB) on Days 3, 15, 28 (Month 1), 45, and last observation (Day 45, Week 12/18).

RESULTS:

Larger EPDS CFB was observed among zuranolone-treated vs. SSRI-treated patients from Day 15 onward. Zuranolone-treated (vs. SSRI-treated) patients exhibited 4.22-point larger reduction in EPDS by Day 15 (95% confidence interval: -6.16, -2.28) and 7.43-point larger reduction at Day 45 (-9.84, -5.02) with Bucher ITC. NMA showed EPDS reduction for zuranolone was 4.52 (-6.40, -2.65) points larger than SSRIs by Day 15 and 7.16 (-9.47, -4.85) larger at Day 45. Lack of overlap between study populations substantially reduced effective sample size post-matching, making HAMD-17 CFB analysis infeasible.

LIMITATIONS:

Limited population overlap between SKYLARK Study and RCTs reduced feasibility of undertaking HAMD-17 CFB ITCs and may introduce uncertainty to EPDS CFB ITC results.

CONCLUSIONS:

Analysis showed zuranolone-treated patients with PPD experienced greater symptom improvement than SSRI-treated patients from Day 15 onward, with largest mean difference at Day 45. Adjusting for differences between placebo arms, zuranolone may be associated with greater PPD symptom improvement (measured by EPDS) vs. SSRIs.

04 Dec 2024·Revista Brasileira de Ginecologia e Obstetricia

Zuranolone for postpartum depression: a systematic review and meta-analysis of two randomized studies

Review

Author: Oliveira, Juliana Almeida ; Freitas, Marcos Aurélio Araújo ; Eskandar, Karine ; Philip, Chris Elizabeth

Objective:

To evaluate the maternal outcomes in women with postpartum depression using zuranolone, the first oral medication indicated to treat postpartum depression.

Methods:

We conducted a systematic search in September 2023, on Pubmed, Embase and Cochrane Trials. We included randomized controlled trials comparing the effectiveness and safety of zuranolone versus placebo in women with postpartum depression. No time or language restrictions were applied. 297 results were retrieved, of which 11 papers were selected and fully reviewed by two authors. Review Manager 5 was used for statistical analysis and Cochrane Risk-of-bias tool for randomized trials was applied for quality assessment.

Results:

We included 2 studies, with 346 women, of whom 174 (50.2%) were treated with zuranolone. Zuranolone was significantly associated to an improvement of Clinical Global Impression response rate; Hamilton Depression Rating Scale 15 days and 45-day remission, 3-day, 15-day, and 45-day symptom remission, and reduction in the dose of antidepressants. As for safety outcomes, it was noticed that zuranolone increases sedation risk, which can be dose related. No significant differences were found for other adverse events.

Conclusion:

These findings suggest that zuranolone might present a safe and effective medication for out-of-hospital treatment of PPD. Sedation effects need to be further assessed.

178

News (Medical) associated with Zuranolone

22 Jan 2025

·www.globenewswire.com

Tenax Therapeutics Appoints Gillian Andor Vice President, Clinical Operations

CHAPEL HILL, N.C., Jan. 22, 2025 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX) (“Tenax Therapeutics” or the “Company”), a Phase 3, development-stage pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, today announced the appointment of Gillian Andor, MSc, as Vice President, Clinical Operations. Ms. Andor will lead the Company’s expanding Clinical Operations function in support of the ongoing Phase 3 program evaluating oral levosimendan (TNX-103) for the treatment of pulmonary hypertension due to heart failure with preserved ejection fraction (PH-HFpEF). “We are pleased to welcome Gillian to the Tenax team at a critical time for our Company, as we continue to enroll patients in the Phase 3 LEVEL study and finalize plans to initiate our second pivotal study,” said Chris Giordano, President and Chief Executive Officer of Tenax Therapeutics. “We believe Gillian’s significant experience executing clinical development programs resulting in NDA submissions and approvals will help us accelerate our Phase 3 program, and ensure we are prepared for global regulatory filings.” Ms. Andor has over 20 years of experience in Clinical Operations. She served most recently as Interim Head, Clinical Development Operations with Noema Pharma, focused on CNS disorders, where she led Clinical Operations and Data Management functions. Prior, she served as Head of Portfolio Operations for Sage Therapeutics, achieving multiple promotions during her nine-year tenure and building a high-functioning Clinical Operations department. Ms. Andor led and supervised the global clinical development programs across Sage’s portfolio in neurology and CNS disorders including successful NDA submissions and approvals for Zulresso® and Zurzuvae®, the first approved medications for postpartum depression. Prior to joining Sage, Ms. Andor held multiple positions within Clinical Operations for Ironwood Pharmaceuticals where she successfully planned, managed, and executed U.S. and European clinical studies in GI disorders, most notably contributing to the NDA and approval of Linzess® for IBS-C. Ms. Andor received a BSc Anatomy (Honors) from the University of Glasgow, where she finished with first class honors, and an MSc in Forensic Science from the University of Strathclyde. Tenax Therapeutics also announced the issuance on January 21, 2025 of an inducement equity award to Ms. Andor in connection with her appointment to the position of Vice President, Clinical Operations of the Company effective the same day. The award consists of an option to purchase 250,000 shares of the Company’s common stock. The award will vest in four equal annual installments beginning on the first anniversary of the date of issuance, subject to Ms. Andor’s continued employment with the Company through each applicable vesting date. The exercise price for the option is $6.44. The award was approved in accordance with Nasdaq Listing Rule 5635(c)(4). About Tenax Therapeutics Tenax Therapeutics, Inc. is a Phase 3, development-stage pharmaceutical company focused on developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need. The Company owns global rights to develop and commercialize levosimendan, which it has prioritized in the near term. Tenax Therapeutics also may resume developing its unique oral formulation of imatinib. For more information, visit www.tenaxthera.com. Tenax Therapeutics’ common stock is listed on The Nasdaq Stock Market LLC under the symbol “TENX”. Caution Regarding Forward-Looking Statements Except for historical information, all of the statements, expectations and assumptions contained in this press release are forward-looking statements. These forward-looking statements may include information concerning possible or projected future business operations. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: our ability to maintain our culture and recruit, integrate and retain qualified personnel and advisors, including on our Board of Directors; risks related to our business strategy, including the prioritization and development of product candidates; risks of our clinical trials, including, but not limited to, the timing, delays, costs, design, initiation, enrollment, and results of such trials; any delays in regulatory review and approval of product candidates in development; reliance on third parties, including Orion Corporation, our manufacturers and CROs; risks regarding the formulation, production, marketing, customer acceptance and clinical utility of our product candidates; our estimates regarding the potential market opportunity for our product candidates; the potential advantages of our product candidates; risks associated with our cash needs; our competitive position; intellectual property risks; volatility and uncertainty in the global economy and financial markets in light of the possibility of pandemics, global financial and geopolitical uncertainties, including in the Middle East and the Russian invasion of and war against the country of Ukraine; changes in legal, regulatory and legislative environments in the markets in which we operate and the impact of these changes on our ability to obtain regulatory approval for our products; and other risks and uncertainties set forth from time to time in our SEC filings. Tenax Therapeutics assumes no obligation and does not intend to update these forward-looking statements except as required by law. Contacts Investor Contact:John FrauncesManaging DirectorLifeSci Advisors, LLCC: 917-355-2395jfraunces@lifesciadvisors.com or Brian MullenLifeSci Advisors, LLCC: 203-461-1175bmullen@lifesciadvisors.com

Phase 3Executive ChangeNDA

17 Jan 2025

·endpts.com

Sage sues Biogen days after $469M buyout offer

Sage Therapeutics has sued Biogen in Delaware court, one week after receiving a $469 million buyout offer from the larger neuroscience pharma company. The full lawsuit was sealed, and the court said the case was confidential after being contacted by Endpoints News . But a separate court filing from Sage states that it is “seeking preliminary injunctive relief to enforce a standstill agreement and a trial on a paper record on an expedited basis.” Biogen declined to comment on ongoing litigation. A spokesperson for Sage said that “any discussions between Biogen and Sage regarding an acquisition of Sage should be conducted in private.” The spokesperson added that the company is seeking a temporary restraining order “to preserve our rights and enforce the standstill provision previously agreed to with Biogen.” Sage is still evaluating the proposal from Biogen, and a decision has not yet been made. The two longtime partners are, for the moment, at odds. Biogen owns roughly 10% of Sage, but the offer is lower than the amount of cash and equivalents the biotech had as of the end of September. The saga started a week ago when Biogen CEO Chris Viehbacher wrote to Sage chief Barry Greene in a publicly disclosed letter outlining the proposal. Though Viehbacher praised Sage’s efforts, he said that Biogen having full control would “enable more streamlined operations and efficient commercial execution” of postpartum depression medication Zurzuvae. The two companies linked up in November 2020 to co-develop and commercialize the drug, then known by its generic name zuranolone. But Sage’s share price has fallen by about 90% in the last five years, as the company has been beset by clinical trial failures. The commercial opportunity for Zurvuvae is also less than hoped for, after the FDA rejected it as a major depression treatment at the same time the PPD indication was approved. Bloomberg Law first reported on the lawsuit. Alexis Kramer contributed reporting.

AcquisitionPatent Infringement

15 Jan 2025

·www.biopharmadive.com

At JPM, Biogen CEO tries to take down the deal temperature

On Tuesday morning, Biogen hosted an event for Wall Street analysts to better understand the company. One of the key topics discussed, according to Brian Abrahams of RBC Capital Markets, was business development.Biogens top drugs have been on the decline, and sales from its newest treatment for Alzheimers disease have yet to impress some investors. Those challenges have, in turn, put pressure on the company to bring in lucrative medicines through dealmaking.Abrahams, in a note to clients, wrote that management clearly appeared to be less vocal about business development opportunities, and highlighted the progress theyve made advancing a couple of lupus drugs and an antibody therapy acquired via a recent $1.2 billion acquisition.Biogen CEO Christopher Viehbacher made similar remarks later on Tuesday during a presentation at the J.P. Morgan Healthcare Conference. We're not necessarily saying, Hey, wow we need to go do a deal. That's not where we are.Viehbacher noted how his company is continually looking for deals that make strategic or financial sense. Another acquisition like that of rare disease specialist Reata Pharmaceuticals, which handed Biogen a marketed therapy called Skyclarys, would be a nice thing, he said. Yet promising, late-stage assets like Skyclarys are really hard to find and the price at which they sell can be inhibitory to doing a deal.Viehbacher admits hes instead biased toward smaller deals, for drugs in the early- to mid-point of human testing.I see some proposals that we should be prepared to overpay. We're never going to do that, not knowingly anyway, he said. I've learned over 35 years you can never actually have enough pipeline, no matter who you are. You should be constantly looking for things.Perhaps to that end, Viehbacher just last week sent an unsolicited letter to one of Biogen's partners, Sage Therapeutics, offering to buythe company for a price analysts think is too low to be seriously considered. Biogen and Sage co-developed, and now split profits on, a postpartum depression drug known as Zurzuvae. Sage said its board of directors will carefully review and evaluate the proposal.“Viehbachers approach doesnt appear to be landing with Biogens investors, however. Shares closed Tuesday trading at $143.06 apiece, the stocks lowest level since 2013. '

Acquisition

100 Deals associated with Zuranolone

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External Link

KEGG	Wiki	ATC	Drug Bank
D11793	Zuranolone	-	DB15490

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Depression, Postpartum	US	SAGE Therapeutics, Inc.	04 Aug 2023
Depression, Postpartum	US	Biogen, Inc.	04 Aug 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Depressive Disorder	NDA/BLA	CA	Biogen, Inc.	01 Dec 2024
Depressive Disorder, Major	NDA/BLA	US	SAGE Therapeutics, Inc.	-
Sleep Initiation and Maintenance Disorders	Phase 3	US	Biogen, Inc.	04 Feb 2019
Bipolar I disorder	Phase 2	US	SAGE Therapeutics, Inc.	23 Aug 2018
Bipolar I disorder	Phase 2	US	Biogen, Inc.	23 Aug 2018
Bipolar II disorder	Phase 2	US	Biogen, Inc.	23 Aug 2018
Bipolar II disorder	Phase 2	US	SAGE Therapeutics, Inc.	23 Aug 2018
Essential Tremor	Phase 2	US	Biogen, Inc.	24 Mar 2017
Parkinson Disease	Phase 2	US	Biogen, Inc.	30 Nov 2016
Seizures	Phase 1	US	SAGE Therapeutics, Inc.	-

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Clinical Result

Indication

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03864614 (SHORELINE Study, Pubmed \| J Clin Psychiatry)	Phase 3	Depressive Disorder, Major	-	Zuranolone 30mg	qluiisjhmr(ybwdthncnb) = Of patients who experienced TEAEs, most reported mild or moderately severe events, and responders to zuranolone experienced improvements in depressive symptoms with initial and repeat treatment courses rukqoxtoza (kbynyapkdg )	Positive	27 Dec 2023
				Zuranolone 50mg
NCT04442490 (CTgov)	Phase 3	Depressive Disorder, Major	543	Placebo (Placebo)	etiiumwjet(upwmfwxjaq) = ztxqtcaclc ynstygqyqg (gyfgnxkedb, xqwcdkxmfv - bxifqosxfi) View more	-	05 Dec 2023
				SAGE-217 (SAGE-217 50 mg)	etiiumwjet(upwmfwxjaq) = pbqsxhytaz ynstygqyqg (gyfgnxkedb, nedrcfivrf - bivwzxcfji) View more
NCT04476030 (CTgov)	Phase 3	Depressive Disorder, Major	440	Escitalopram+Matching Placebo+Sertraline+Desvenlafaxine+Duloxetine+Citalopram (Placebo + Assigned ADT)	zanijcwyuy(ueefqnkpqf) = lecjbaypup hmuixxzolc (hdvhwapjui, crntcqufbr - vjpojudjjb) View more	-	07 Nov 2023
				Escitalopram+Sertraline+Desvenlafaxine+Duloxetine+SAGE-217+Citalopram (SAGE-217 + Assigned ADT)	zanijcwyuy(ueefqnkpqf) = vszuaxeooi hmuixxzolc (hdvhwapjui, ophwyppqcn - xksouuyfhz) View more
NCT04442503 (Pubmed \| Am J Psychiatry)	Phase 3	Depression, Postpartum	196	Zuranolone 50 mg/day	tbgwqiujis(hpyjahkhbo) = xwqirxecnv crfpduiawr (lletxfftzh )	Positive	01 Sep 2023
				Placebo	tbgwqiujis(hpyjahkhbo) = vwyrzvqjsf crfpduiawr (lletxfftzh )
NCT04442503 \| NCT02978326 (FDA) Manual	Phase 3	Depression, Postpartum	345	ZURZUVAE 50 mg (Study 1)	lhuonbyfmf(cmjxfdygtx) = cmldbhkpnr tanmheqdmj (snjlpznqci, 0.82)	Positive	04 Aug 2023
				Placebo (Study 1)	lhuonbyfmf(cmjxfdygtx) = xoqquldgov tanmheqdmj (snjlpznqci, 0.82)
NCT04442503 (CTgov)	Phase 3	Depression, Postpartum	200	Placebo (Placebo)	ocvrrocxbu(ajldnzxxcz) = tnyqqgdisp udldcmvatr (urukzwbzzy, zjtmfulpkq - hntizbtwyj) View more	-	22 Jun 2023
				SAGE-217 (SAGE-217 50 mg)	ocvrrocxbu(ajldnzxxcz) = dmulsnillw udldcmvatr (urukzwbzzy, vysrxonqfv - vzwqlxpvei) View more
NCT03771664 (CTgov)	Phase 3	Sleep Initiation and Maintenance Disorders \| Depressive Disorder, Major	87	Placebo (Placebo)	cefjremutz(cipuxmfpgo) = vknlbgtidj xxszvvdgrh (mwjhxyriba, tmqjvfdbyw - qrrqivrdeu) View more	-	20 Oct 2022
				SAGE-217 (SAGE-217)	cefjremutz(cipuxmfpgo) = pmngrmvzqq xxszvvdgrh (mwjhxyriba, xyfpnzrhyf - lkpcspjxcu) View more
NCT04007367 (CTgov)	Phase 3	Depressive Disorder, Major	53	Placebo (Double-Blind Phase: Placebo)	pdocnqvgmq(njqhowvuzs) = dakyylbzym oadzxwquya (zpxdnitqob, roazfayisk - suafjgdwdt) View more	-	03 Oct 2022
				SAGE-217 (Double-Blind Phase: SAGE-217)	lrlcwgbdls(cvjhnqpygd) = udxzmsxbmt uhyugckubo (kdgepzzrig, iimqcnlhug - hvkptesvcc) View more
NCT03864614 (SHORELINE, Corporate Publications) Manual	Phase 3	Depressive Disorder, Major	924	Zuranolone (30mg cohort)	aorkfrhwyk(logomqnvbh) = there was a mean reduction in the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score from baseline to Da15 ofcalxelqh (wirhvwhpav )	Positive	19 Sep 2022
				Zuranolone (50 cohort)
NCT02978326 (CTgov)	Phase 3	Depression, Postpartum	276	SAGE-217 15/20 mg Oral Solution (Part A: SAGE-217 15/20 mg Oral Solution)	rcgrckboza(lmdejuuaoh) = ktcdbtgjhc bfxszgpcwt (wcrgqfrytj, zdzcrmletm - lunnwldojm) View more	-	16 Dec 2021
				Placebo (Part B: Placebo)	qyhepcagke(nscscriopk) = bpferpycam zqozapjjwd (blknefyttv, vsdwhdjjzq - cwumkctsiy) View more