A pilot study to investigate the potential role of atosiban, a selective oxytocin receptor inhibitor, in the management of endometriosis-related pain. Ten patients will be administered atosiban intravenously during 6 hours on a day during their period when they experience (severe) pain

Start Date01 Feb 2022

Sponsor / Collaborator

Radboud University Medical Center

NCT03904745 / Unknown statusNot ApplicableIIT

Effect of Oxytocin Antagonists on Implantation Success Rates of Frozen-thawed Embryo Transfer

Uterine contraction has a negative impact on implantation and pregnancy rates. Inhibition of oxytocin receptors decreases uterine contraction frequency both on pregnant and non-pregnant women. Atosiban has been studied as an oxytocin antagonist to decrease uterine contraction frequency in order to increase implantation and pregnancy rates in assisted reproduction. Previous studies have studied 37,5mg total dose which was used both before and during embryo transfer, and found atosiban to be effective in increasing implantation and pregnancy rates. We aim to use a single dose of 6,75mg atosiban before embryo transfer, in order to decrease the dose and cost and possibly introduce a simpler protocol. Our study will also be the first randomized clinical study which investigates the effect of atosiban on frozen-thawed embryo transfer cycles.

Start Date21 Dec 2020

Sponsor / Collaborator

Bezmialem Vakif University

[+1]

100 Clinical Results associated with Atosiban acetate

100 Translational Medicine associated with Atosiban acetate

100 Patents (Medical) associated with Atosiban acetate

495

Literatures (Medical) associated with Atosiban acetate

01 Dec 2024·European journal of obstetrics & gynecology and reproductive biology: X

Effects of nationwide adjustment of tocolysis protocol in the Netherlands on neonatal outcomes in women with threatened preterm birth and delivery at 30-32 weeks of gestation: A cohort study

Article

Author: Ravelli, A.C.J. ; van der Windt, L.I. ; Meliezer, J.A.L. ; Ravelli, A C J ; Oudijk, M A ; Onland, W ; Meliezer, J A L ; van der Windt, L I ; Onland, W. ; Oudijk, M.A.

Objective:

In 2019 the Dutch national prevention of preterm birth (PTB) protocol was adjusted to withhold tocolysis for threatened PTB above 30 weeks of gestation due to insufficient evidence regarding its effectiveness on improving perinatal outcomes. The aim of this study is to evaluate neonatal outcomes of children born in the Netherlands between 30 and 32 weeks of gestation before and after the national protocol change.

Study design:

We performed a nationwide retrospective cohort study comparing outcomes of births in the years 2018 (tocolysis) and 2020 (no tocolysis). Tocolytic therapy consisted of either nifedipine or atosiban. Data were extracted from the national Perinatal Registry (PERINED). Women with a spontaneous PTB from 30 + 0 to 31 + 6 weeks of gestation were included. The primary outcome was a composite of mortality, severe intraventricular hemorrhage, severe necrotizing enterocolitis, cystic periventricular leukomalacia, and retinopathy of prematurity needing therapy. Secondary outcomes included additional neonatal outcomes. The odds ratio (OR) with corresponding 95 % confidence interval (CI) was calculated by logistic regression analysis for the year 2020 compared with 2018.

Results:

Composite neonatal outcome did not differ between 2018 compared to 2020 (8.4 % (18/215) vs 8.2 % (25/306), OR 0.95; 95 % CI 0.51-1.77). No difference in composite neonatal outcome was found when analyzing groups as singletons (7.1 % vs 9.3 %, OR 1.35; 95 % CI 0.64-2.87), and multiples (13.3 % vs 5.9 %, OR 0.41; 95 % CI 0.13-1.26).

Conclusion:

There was no significant difference in composite neonatal outcome in pregnancies resulting in spontaneous PTB between 30 and 32 weeks of gestation in 2018 (with tocolysis) compared to 2020 (no tocolysis). These results support the protocol adjustment to withhold tocolytic treatment in women with threatened PTB above 30 weeks of gestation.

01 Oct 2024·MEDICINA CLINICA

Drug-induced hyponatraemia and possible related signals: Analysis of 659 cases reported to the Spanish Pharmacovigilance System and disproportionality analysis

Article

Author: Sainz-Gil, María ; Estévez Asensio, Lucía ; Fernández-Araque, Ana M. ; Verde Rello, Zoraida ; Velasco-González, Verónica ; Fernández-Araque, Ana M ; García, Montserrat

INTRODUCTION:

Hyponatraemia has negative effects on cognitive function and gait stability and is a risk factor for osteoporosis, falls, fractures and hospital mortality. Acute hyponatraemia can lead to neurological dysfunction due to cerebral oedema. Its rapid correction can also be fatal, leading to osmotic demyelination syndrome. For some antiepileptics, thiazides, benzodiazepines or antidepressants this reaction is widely described. Knowing which drugs are most likely to cause hyponatraemia will allow early detection and prevention of its complications, as well as individualising the prescription of these drugs according to the patient's characteristics.

OBJECTIVE:

The main objectives are to identify potential new safety signals related to hyponatraemia and to analyse the cases of hyponatraemia reported to the Spanish Pharmacovigilance System for Medicines for Human Use (SEFV-H).

METHOD:

A disproportionality and a descriptive analysis of individual case safety reports (ICSR) was performed in the SEFV-H database (FEDRA).

RESULTS:

Six hundred and fifty-nine cases of suspected drug-induced hyponatraemia were found (0.6% of the total database). Over the 5 years period studied, there was a 57% increase in the number of hyponatraemia reports in Spain. Most of the reported cases were serious (93%). Patients were most often women (63.7%) and elderly (71.9%). The time to onset ranged from 1 to 7030 days (median, 79 days) and approximately 70% of the total occurred within the first year of treatment. Five hundred and forty-six patients (82.9%) showed complete recovery after the withdrawal of the suspected medicine. Diuretics (reported in 57.7% of the cases), antidepressants (in 25%), drugs acting on renin angiotensin system (in 24%) and antiepileptics (in 20.2%) were the most frequent involved drugs. Disproportionate reporting has been found for almost all the substances most frequently reported, higher for amiloride and oxcarbazepine. Regarding new safety signals, the Reporting Odds Ratio (ROR) (95% CI) was found to be statistically significant for valsartan [7.7 (5.1-11.5)], olmesartan [7.3 (4.7-11.1)], amlodipine [3.4 (2.1-5.4)], pregabalin [2.5 (1.4-4.5)], irbesartan [18.6 (9.6-35.9)], paliperidone [2.7 (1.3-5.7)], ritonavir [2.4 (1.1-5.5)], atosiban [29.7 (8.6-102.2)], melphalan [9.7 (3.5-26.8)] and clozapine [4.4 (1.6-11.8)]. These active ingredients do not include this reaction on their SPC and comply with the EMA criteria for a safety signals.

CONCLUSION:

There are increasing reports of drug-induced hyponatraemia. It can be serious and seems to most often affect women over 65 years of age who take more than 1 medication. The time to onset varies and can be very long, so patient monitoring should be continuous throughout treatment. Hydrochlorothiazide is the drug with the highest number of reported cases in our setting. In terms of disproportionate reporting, diuretics leads the list, followed by antiepileptics as oxcarbazepine and eslicarbazepine. Safety signals were found for several drugs, more plausibly for pregabalin and paliperidone, thus a possible association between these drugs and hyponatraemia/SIAD is identified. This signal must be further studied. Meanwhile healthcare professionals should pay attention to this possibility. The reporting of suspected ADRs is essential to understand the risks associated with medicines once they are on the market.

01 Sep 2024·European journal of hospital pharmacy : science and practice

A new approach to drug intravenous compatibility research: the case of obstetric parenteral drugs

Article

Author: Wilhelm, A J ; van Merendonk, L N ; Bet, P M ; Kolkman, A ; de Boer, M A ; Leeuwerik, A F

OBJECTIVES:

The product information and literature does not provide confirmation of compatibility for co-administration of all commonly used drug pairs in obstetrics. However, there is a need for co-administration of these drugs over one lumen for this group of patients. Therefore, this study focuses on Y-site compatibility. Since different conditions between clinical and laboratory settings can lead to discrepancies in results, a novel approach for drug intravenous compatibility testing was designed to reflect clinical conditions. The aim was to study the compatibility of nine commonly used drug pairs in obstetrics and to evaluate the clinical value of the designed method.

METHODS:

The clinical situation was reflected by using different temperature ranges (20°C and 37°C), actual Y-site flow ratios, clinically relevant drug pairs and an observation time of 120 min. The clinically relevant drugs pairs include atosiban, nicardipine, amoxicillin/clavulanic acid, oxytocin, remifentanil, labetalol and magnesium sulpfate. Drug pairs were visually assessed according to the European Pharmacopoeia (Ph. Eur.) and pH was measured. When incompatibility of a drug pair seemed likely based on literature review or observed abnormalities during visual assessment, subvisual analysis was performed using a particle counter. Y-site compatibility applied for drug pairs when no visual changes occurred or when no additional particles were formed during the observation time.

RESULTS:

Eight of the nine combinations showed no visual changes or noticeable changes in pH during the observation time. The amoxicillin/clavulanic-acid-oxytocin combination showed a colour change at 37°C at the actual Y-site flow ratio. However, subvisual particle counting showed no formation of additional particles.

CONCLUSIONS:

Y-site compatibility was established for all tested drug pairs. The new clinical approach for analysing Y-site compatibility provides a high certainty of outcomes for clinical practice. In this way, clinical complications and use of several additional intravenous catheters can be avoided.

News (Medical) associated with Atosiban acetate

22 Nov 2022

·www.biospace.com

XOMA Acquires Royalty and Milestone License to Ebopiprant, a Preterm Labor Asset, Being Developed by Organon

XOMA assumes the rights to ebopiprant from ObsEva, including the Organon License, Patent Estate, and Merck KGaA, Darmstadt, Germany, license, for a $15 million outlay Potential to earn $475 million in development, regulatory, and sales milestones Low- to mid- teens royalties upon commercialization Expands XOMA’s portfolio into new therapeutic segment – women’s health EMERYVILLE, Calif., Nov. 22, 2022 (GLOBE NEWSWIRE) -- XOMA Corporation (NASDAQ: XOMA), a biotech royalty aggregator playing a distinctive role in helping biotech companies achieve their goal of advancing novel therapeutic candidates aimed at improving human health, announced today it has acquired all rights and title to ebopiprant held by ObsEva for $15 million plus certain earn-out payments. XOMA has assumed the ebopiprant intellectual property (IP) estate and all license agreements, including the 2021 exclusive license agreement from ObsEva to Organon related to the development and commercialization of ebopiprant. “We are very pleased to add ebopiprant to XOMA’s royalty and milestone portfolio. Preterm labor is extremely stressful for expectant parents and their families. The costs to care for premature babies can quickly escalate to hundreds of thousands of dollars, resulting in long-term financial distress for many families,” stated Jim Neal, Chairman and Chief Executive Officer of XOMA. “The economics in the ebopiprant license acquisition have the potential to deliver significant returns to XOMA and our stockholders from the clinical development milestones alone. We wish Organon, a global women’s health company, success in its development activities with ebopiprant.” Under the terms of the agreement, XOMA has acquired all rights to ebopiprant held by ObsEva, including the Organon/ObsEva license agreement and the IP associated with the asset. XOMA will now be entitled to receive up to $475 million in development, regulatory, and sales-based milestone payments under the ObsEva/Organon license agreement. XOMA will pay to ObsEva a portion of the development and regulatory milestones, as well as certain sales milestones, up to $98 million. Upon commercialization, XOMA will receive royalties that range from low- to mid-teens from Organon and will make a mid-single-digit royalty payment to Merck KGaA, Darmstadt, Germany. About Ebopiprant Ebopiprant (OBE022) was licensed by ObsEva from Merck KGaA, Darmstadt, Germany, in 2015. ObsEva previously announced positive results from PROLONG Part B, a 113-patient Phase 2a proof-of-concept, randomized, double-blind, placebo-controlled trial in women experiencing spontaneous preterm labor that compared atosiban (ex-U.S. standard of care) plus ebopiprant versus atosiban plus placebo for 7 days. In the study, ebopiprant plus atosiban reduced delivery in singleton pregnancies at 48 hours after the start of dosing by 55% compared to atosiban plus placebo. Overall, 12.5% of women receiving ebopiprant plus atosiban delivered within 48 hours of starting treatment compared to 21.8% receiving atosiban plus placebo (OR 90% CI: 0.52 (0.22, 1.23)). The incidence of maternal, fetal, and neonatal adverse events were comparable between both the ebopiprant and placebo groups. About XOMA Corporation XOMA is a biotechnology royalty aggregator playing a distinctive role in helping biotech companies achieve their goal of improving human health. XOMA acquires the potential future economics associated with pre-commercial therapeutic candidates that have been licensed to pharmaceutical or biotechnology companies. When XOMA acquires the future economics, the seller receives non-dilutive, non-recourse funding they can use to advance their internal drug candidate(s) or for general corporate purposes. The Company has an extensive and growing portfolio with more than 70 assets (asset defined as the right to receive potential future economics associated with the advancement of an underlying therapeutic candidate). For more information about the Company and its portfolio, please visit Forward-Looking Statements/Explanatory Notes Certain statements contained in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including statements regarding the timing and amount of potential commercial payments to XOMA and other developments related to ebopiprant, the potential of XOMA’s portfolio of partnered programs and licensed technologies generating substantial milestone and royalty proceeds over time, and XOMA’s cash sufficiency forecast. In some cases, you can identify such forward-looking statements by terminology such as “anticipate,” “intend,” “believe,” “estimate,” “plan,” “seek,” “project,” “expect,” “may,” “will”, “would,” “could” or “should,” the negative of these terms or similar expressions. These forward-looking statements are not a guarantee of XOMA’s performance, and you should not place undue reliance on such statements. These statements are based on assumptions that may not prove accurate, and actual results could differ materially from those anticipated due to certain risks inherent in the biotechnology industry, including those related to the fact that our product candidates subject to out-license agreements are still being developed, and our licensees may require substantial funds to continue development which may not be available; we do not know whether there will be, or will continue to be, a viable market for the products in which we have an ownership or royalty interest; if the therapeutic product candidates to which we have a royalty interest do not receive regulatory approval, our third-party licensees will not be able to market them; and the impact to the global economy as a result of the COVID-19 pandemic. Other potential risks to XOMA meeting these expectations are described in more detail in XOMA's most recent filing on Form 10-K and in other filings with the Securities and Exchange Commission. Consider such risks carefully when considering XOMA's prospects. Any forward-looking statement in this press release represents XOMA's beliefs and assumptions only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. XOMA disclaims any obligation to update any forward-looking statement, except as required by applicable law. EXPLANATORY NOTE: Any references to “portfolio” in this press release refer strictly to milestone and/or royalty rights associated with a basket of drug products in development. Any references to “assets” in this press release refer strictly to milestone and/or royalty rights associated with individual drug products in development. As of the date of this press release, all assets in XOMA’s milestone and royalty portfolio, except Vabysmo®, are investigational compounds. Efficacy and safety have not been established. There is no guarantee that any of the investigational compounds will become commercially available. XOMA Investor Contact XOMA Media Contact Juliane Snowden Kathy Vincent XOMA Corporation KV Consulting & Management +1 646-438-9754 +1 310-403-8951 juliane.snowden@xoma.com kathy@kathyvincent.com

Clinical ResultLicense out/in

30 Jul 2021

·endpts.com

Merck's women's health spinout snags mid-stage candidate for preterm birth; Keytruda nails down TNBC approval after March CRL

Nearly two months after spinning out from Merck, women’s health business Organon has struck its first half-billion-dollar deal. Organon $OGN has promised $25 million upfront and another $475 million in biobucks for worldwide rights to ebopiprant, ObsEva’s investigational treatment for preterm labor. Ebopiprant, a selective prostaglandin F2α (PGF2α) receptor antagonist, was originally licensed from Merck KGaA in 2015. The candidate works by reducing inflammation and uterine contractions. “This development-stage asset is being studied in one of the most crucial unmet needs for women globally,” Organon CEO Kevin Ali said in a statement. There are currently no approved drugs for the acute treatment of preterm labor in the US. Back in November, ObsEva said ebopiprant reduced the delivery of pregnancies (not including twin pregnancies) by 55% at 48 hours when administered with atosiban (the ex-US standard of care), compared to atosiban alone. Overall, 12.5% of women in the treatment arm delivered babies within 48 hours of starting treatment, compared to 21.8% in the placebo arm, ObsEva said of the Phase IIa trial. “The incidence of maternal, fetal and neonatal adverse events were comparable between subjects in the ebopiprant group and the placebo group,” the company said. Organon officially spun out from Merck on June 3 with a portfolio of more than 60 medicines, including Nexplanon, its long-active reversible contraceptive. Nexplanon is one of the top hormonal contraceptives in the country, according to IQVIA data, and grew at an annual compound growth rate of 9% between 2014 and 2019. — Nicole DeFeudis Keytruda nails down TNBC approval after March CRL Merck’s blockbuster checkpoint inhibitor Keytruda has won another FDA approval, this time in a line of triple-negative breast cancer. Regulators handed down the greenlight for the treatment of patients with high-risk early-stage TNBC in combination with chemo, as neoadjuvant and then continued as a single agent as adjuvant treatment after surgery. The thumbs up marks the 30th indication for which the Keytruda is approved in the US, Merck said. Additionally, the FDA converted the Keytruda-chemo combo accelerated approval in locally recurrent unresectable or metastatic TNBC for tumors expressing PD-L1 to full approval. The TNBC approval comes after the FDA handed Merck a rare CRL for Keytruda back in March, after an adcomm unanimously voted to recommend waiting for more data for the study in question. Advisers and regulators pointed toward concerns over the trial’s event-free survival primary endpoint over placebo, saying researchers hadn’t watched patients long enough after treatment to determine EFS and OS. But a few weeks later, Merck claimed a win in the study after claiming it reached the interim analysis checkpoint. The trial, known as KEYNOTE-522, met its dual primary endpoints of event-free survival and pathological complete response. — Max Gelman

CollaborateAccelerated Approval

27 Jul 2021

·www.pharmatimes.com

Organon and ObsEva to collaborate on preterm labour treatment

Women’s health company Organon has signed a license agreement with Swiss biopharma company ObsEva to develop a potential treatment for preterm labour. Under the terms of the agreement, Organon will license the global development, manufacturing and commercial rights to ebopiprant, an investigational selective prostaglandin F2α (PGF2α) receptor antagonist. Ebopiprant is being evaluated for the treatment for preterm labour by reducing inflammation and uterine contraction – if approved, it has the potential to be a first-in-class therapy for the condition in the US. ObsEva will receive tiered double-digit royalties on commercial sales of ebopiprant as well as up to $500m in upfront and milestone payments. This includes $25m to be paid upon signing of the deal, up to a further $90m in development and regulatory milestones and up to $385m in sales-based milestones. Last year, ObsEva announced positive results from a Phase IIa trial of ebopiprant in preterm labour. In this trial, the PGF2α receptor agonist reduced delivery in singleton pregnancies at 48 hours after the start of dosing by 55% compared to atosiban, the ex-US standard of care treatment for preterm labour. Overall, 12.5% of women receiving ebopiprant delivered within 48 hours of starting treatment compared to 21.8% on placebo. In singleton pregnancies, 12.5% of women receiving ebopiprant treatment delivered with 48 jours compared to 26.8% in the placebo group. “This development-stage asset is being studied in one of the most crucial unmet needs for women globally. As we build Organon’s women’s health research and development portfolio, the agreement strengthens our path to long term growth,” said Kevin Ali, chief executive officer of Organon. “Organon and ObsEva share a commitment to improve the lives of women around the world. Through Organon’s strong development, scientific and medical capabilities, our goal is to change the future for millions of mothers and babies,” he added.

CollaborateFirst in Class

100 Deals associated with Atosiban acetate

External Link

KEGG	Wiki	ATC	Drug Bank
-	Atosiban acetate	G02CX01	DB09059

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Obstetric Labor, Premature	EU	Ferring Pharmaceuticals A/S	20 Jan 2000
Obstetric Labor, Premature	IS	Ferring Pharmaceuticals A/S	20 Jan 2000
Obstetric Labor, Premature	LI	Ferring Pharmaceuticals A/S	20 Jan 2000
Obstetric Labor, Premature	NO	Ferring Pharmaceuticals A/S	20 Jan 2000

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02893722 (Pubmed)	Phase 1	-	194	Atosiban	ubuavqmejl(jfbrqsohet) = vnbxgqgslw zwuoolqxkx (ajsqtgtctp )	-	19 Aug 2022
				Placebo	ubuavqmejl(jfbrqsohet) = fqztzyzbqi zwuoolqxkx (ajsqtgtctp )
NCT03570294 (Pubmed \| Oxid Med Cell Longev)	Not Applicable	Obstetric Labor, Premature	56	Atosiban	oxwhgikdzu(utpwiivljt) = tdldnwhuiv qdrrfqhkif (diqtsrrdip ) View more	-	01 Jan 2018
ChiCTR-IOQ-14005715 (Pubmed \| Fertil Steril)	Phase 1	Endometriosis	-	Atosiban treatment	cxzsefoyjs(tdwrvxmxjo) = dhjsjpqqui amgcotbjqz (jrjqedvheq ) View more	-	01 Aug 2016
				atosiban (Control group)	cxzsefoyjs(tdwrvxmxjo) = bhvfkwklkx amgcotbjqz (jrjqedvheq ) View more
NCT01501214 (Pubmed \| Hum Reprod)	Not Applicable	Ventricular Fibrillation, Paroxysmal Familial, 1	800	Atosiban	(pziewcymbp) = pnajvwezij avpjmwnhco (odukhlhqaf )	-	01 Dec 2014
				Placebo	(pziewcymbp) = civazmtczg avpjmwnhco (odukhlhqaf )
NCT02893722 (Pubmed \| Reprod Biomed Online)	Phase 1	-	71	Atosiban	mcpydidofp(adzcibkiso) = qdwzfjfnhb wwdpjxnvcc (xersraknwd ) View more	-	01 Sep 2012

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