Delving into the Latest Updates on Beractant with Synapse

Overview

Basic Info

Drug Type

Biological products

Synonyms

Beractant (USAN), Surfacten

+ [2]

Target-

Mechanism-

Therapeutic Areas

Respiratory DiseasesOther Diseases

Active Indication

Respiratory Distress Syndrome in Premature InfantsRespiratory Distress Syndrome

Inactive Indication-

Originator Organization

AbbVie, Inc.

Active Organization

AbbVie, Inc.Mitsubishi Tanabe Pharma Factory Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

JP (02 Oct 1987),

Respiratory Distress Syndrome

RegulationOrphan Drug (US)

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Introduction Respiratory distress syndrome (RDS) is a leading cause of morbidity and mortality among preterm infants, necessitating effective treatment strategies. This study compared the efficacy of Beractant (SURVANTA®) to Poractant alfa (CUROSURF®) in treating RDS in preterm infants admitted to Tawam Hospital in the UAE. Methodology This retrospective study included preterm infants from 23+0 to 36+6 weeks of gestation with a diagnosis of RDS and treatment by Beractant or Poractant alfa within 48 hours of life between January 2020 and March 2023. Data collected from electronic medical records of Tawam Hospital include infant and maternal demographics, primary outcome parameters, such as bronchopulmonary dysplasia (BPD) and/or mortality, and secondary outcome parameters, such as surfactant redosing, air leak syndrome, and other complications. Results A total of 258 infants met the inclusion criteria: 178 were treated with Beractant, and 80 were treated with Poractant alfa. After adjusting the confounding factors, the occurrence of bronchopulmonary dysplasia (BPD) was not statistically significant, showing rates of 68.7% (n=46) in the Poractant group and 47.5% (n=75) in the Beractant group (p=0.71). Likewise, there was no significant difference in mortality rates between the two groups, with 22.5% (n=18) in the Poractant group and 11.8% (n=21) in the Beractant group (p=0.33). Furthermore, the combined incidence of BPD or mortality was also not statistically significant, recorded at 53.4% (n=95) for the Beractant group compared to 73.8% (n=59) for the Poractant group (p=0.93). However, the need for surfactant redosing and air leak syndrome was significantly lower in the Poractant group compared to the Beractant group, 26.2% (n=21) vs 45.5% (n=81), p < 0.00001 and 8.8% (n=7) vs 14.6% (n=26), p = 0.05, respectively. There was no difference in the incidence of other outcomes such as pulmonary hemorrhage, periventricular leukomalacia (PVL), intraventricular hemorrhage (IVH), necrotizing enterocolitis (NEC), significant patent ductus arteriosus (PDA), and retinopathy of prematurity (ROP) that required treatment. Conclusion There was no significant difference in the rates of bronchopulmonary dysplasia or mortality between Poractant alfa (CUROSURF®) and Beractant (SURVANTA®) in preterm infants suffering from respiratory distress syndrome. Poractant alfa (CUROSURF®) showed a reduced need for surfactant redosing and a lower incidence of air leak syndrome. However, the rates of other outcomes, including significant patent ductus arteriosus (PDA), intraventricular hemorrhage (IVH), retinopathy of prematurity (ROP), periventricular leukomalacia (PVL), and necrotizing enterocolitis (NEC), were comparable in both treatment groups. Further randomized prospective studies are necessary to evaluate these types of surfactants and investigate their efficacy as well as both short- and long-term outcomes.

01 Oct 2024·American Journal of Physiology-Lung Cellular and Molecular Physiology

Comparative biophysical study of clinical surfactants using constrained drop surfactometry

Article

Author: Zuo, Yi Y.

A thorough investigation into the biophysical properties of four animal-derived clinical surfactant preparations was conducted through constrained drop surfactometry under physiologically relevant conditions. This comparative study unveiled unique in vitro biophysical characteristics among these clinical surfactants, establishing correlations between their chemical composition, lateral film structure, and biophysical functionality. The acquired knowledge offers essential insights for the precise and personalized design of clinical surfactant for the treatment of respiratory distress syndrome and other respiratory conditions.

01 Apr 2024·American Journal of PerinatologyQ4 · MEDICINE

Pulmonary Complications in Premature Infants Using a Beractant or Poractant for Respiratory Distress Syndrome: A Retrospective Cohort Study

Q4 · MEDICINE

Article

Author: Siu, Kiu Lok ; Wong, Kin Lok

Objective Premature infants are at the risk of developing respiratory distress syndrome (RDS). Beractants and poractants are two commonly used natural surfactants. This retrospective cohort study aims to compare the incidence of pulmonary complications between beractant and poractant treatment groups. Study Design This study evaluated 29 patients treated with beractant and 49 patients treated with poractant. The primary outcome was the incidence of air leak syndrome (ALS) and pulmonary hemorrhage. Secondary outcomes included mortality and pulmonary outcomes, such as mechanical ventilation duration, oxygen dependence duration, fraction of inspired oxygen, and mean airway pressure (MAP) requirement. Logistic regression analyses were conducted to identify independent risk factors for significant primary outcomes. Results No significant difference was found in the demographics between the two groups. A significantly higher incidence of pulmonary hemorrhage was observed in the poractant group (14.3 vs. 0.0%, p = 0.038). The difference in the incidence of ALS between the groups was insignificant (p = 0.536). Logistic regression for the incidence of pulmonary hemorrhage identified coagulopathy as the only significant independent risk factor (odds ratio 39.855, 95% confidence interval [2.912–545.537]; p = 0.006). Secondary outcomes in both treatment groups were similar, except that patients in the poractant group had a higher MAP before surfactant therapy (9 vs. 8 cmH2O, p < 0.001). Conclusion This study showed a significantly higher incidence of pulmonary hemorrhage in the poractant group. Coagulopathy was identified as an independent risk factor for pulmonary hemorrhage. Future long-term prospective studies are essential to establish the temporal and causal relationships between coagulopathy and pulmonary hemorrhage in premature infants receiving surfactant therapy for RDS; hence, there is the need for a screening protocol before surfactant administration. Key Points

100 Deals associated with Beractant

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External Link

KEGG	Wiki	ATC	Drug Bank
D03096	Beractant	R07AA02	DB06761

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Respiratory Distress Syndrome in Premature Infants	US	AbbVie, Inc.	01 Jul 1991
Respiratory Distress Syndrome	JP	Mitsubishi Tanabe Pharma Factory Ltd.	02 Oct 1987

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00767039 (CAST, CTgov)	Phase 4	Ductus Arteriosus, Patent \| Respiratory Distress Syndrome, Adult \| Obstetric Labor, Premature	52	beractant+Survanta (Beractant Arm)	vijmwwjnqj(pbkmfgjbfv) = wrthhaabec sojiiuqyrl (hrglpaeprs, capdpggdvd - isyrfisuir) View more	-	20 Sep 2011
				Poractant Alfa (Poractant Alfa Arm)	vijmwwjnqj(pbkmfgjbfv) = wxudddscvj sojiiuqyrl (hrglpaeprs, fidvmuvpce - azbzhwlhvg) View more
NCT00767039 (Pubmed \| J Perinatol)	Phase 4	Respiratory Distress Syndrome	50	Poractant alfa	emjkcsztke(yzqmhxrsbp) = oinrvjjfrz fsvhszwnoo (jgleduodzq )	-	01 Oct 2010
				Beractant	emjkcsztke(yzqmhxrsbp) = rfyizblmuz fsvhszwnoo (jgleduodzq )