Copyright (c) 2020 Sidra Tanwir
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
Lucinactant: a New Solution in Treating Neonatal Respiratory Distress Syndrome NRDS
Corresponding Author(s) : Sidra Tanwir
International Journal of Allied Medical Sciences and Clinical Research,
Vol. 2 No. 2 (2014): 2014 Volume 2- Issue -2
Abstract
Lucinactant is a novel synthetic surfactant, approved by the FDA on March 6th 2012, for use in treatment of RDS. It’s superiority as compared to the previously approved surfactants lie in containing sinapultide, a 21-amino acid peptide also known as KL4 peptide, which has been designed to mimic the activity of human surfactant protein. Lucinactant is completely devoid of any animal derived components. It is the fifth drug approved by the FDA for the treatment of RDS. It has shown immense efficacy in phase two clinical trials and animal model studies and exhibited better efficiency when compared to other surfactants in both 24 hour and two week mortality rates of infants in RDS. Lucinactant tends reduce the surface tension at the air-liquid interface of alveolar surfaces and allows lungs to function normally. It was observed that the side effects were lesser with Lucinactant when compared with other naturally derived surfactants.
Keywords
Lucinactant
surfactant
RDS
Sinapultide
References
-
[1]. Engle WA. Surfactant-Replacement Therapy for Respiratory Distress in the Preterm and Term Neonate. Pediatrics. 2008. 121:419 P.
[2]. American Academy of Pediatrics, Committee on Fetus and Newborn. Surfactant replacement therapy for respiratory distress syndrome. Pediatrics. 1999. 103(3):684–685 P.
[3]. Saigal S, Pinelli J, Hoult L, Kim MM, Boyle M. Psychopathology and social competencies of adolescents who were extremely low birth weight. Pediatrics. 2003. 111:969–975 P.
[4]. Avery ME, Mead J. Surface properties in relation to atelectasis and hyaline membrane disease. AMA J Dis Child. 1959. 97:517-523 P.
[5]. Fujiwara T, Maeta H, Chida S, Morita T, Watabe Y, Abe T. Artificial surfactant therapy in hyaline-membrane disease. Lancet. 1980. 12:1(8159):55–59 P..
[6]. Ramanthan R, Kamholz K, Fujii AM .Is there a Difference in Surfactant Treatment of Respiratory Distress Syndrome in Premature Neonates? A Review. J Pulmon Resp Med. 2013. 813 P.
[7]. [Newsletter]. Discovery Labs Announces FDA Approval of SURFAXIN® (lucinactant) for Prevention of Respiratory Distress Syndrome. [Conference call]. Available from http://www.prnewswire.com/news-releases/discovery-labs-announces-fda-approval-of-surfaxin-lucinactant-for-prevention-of-respiratory-distress-syndrome-141639603.html
[8]. Ma CC, Ma S. The Role of Surfactant in Respiratory Distress Syndrome. Open Respir Med J. 2012. 6: 44-53 P.
[9]. Moen MD, Perry CM, Wellington K. Lucinactant; in Neonatal Respiratory Distress Syndrome. Treat Respir Med. 2005. 4:139-145 P.
[10]. Wolfson MR, Wu J, Hubert TL, Gregory TJ, Mazela J, Shaffer TH. Lucinactant attenuates pulmonary inflammatory response, preserves lung structure, and improves physiologic outcomes in a preterm lamb model of RDS. Pediatr Res. 2012. 72:375-381 P.
[11]. Gilliard N, Richman PM, Merritt TA, Spragg RG. Effect of volume and dose on the pulmonary distribution of exogenous surfactant administered to normal rabbits or to rabbits with oleic acid lung injury. Am Rev Respir Dis. 1990. 141:743–747 P.
[12]. Terry MH, Merritt TA, Harding B, Schroeder H, Merrill-Henry J, Mazela J, Gregory TJ, Segal R, Power GG, Blood AB. Pulmonary distribution of lucinactant and poractant alfa and their peridosing hemodynamic effects in a preterm lamb model of respiratory distress syndrome. Pediatr Res. 2010. 68:193–198 P.
[13]. Kerry L. Dechant, Diana Faulds. Colfosceril Palmitate. Drugs November 1991. 42:877-894 P.
[14]. Poractant alfa. [internet]. Medscape reference for drugs. [homepage on internet]. [updated 2013; cited 2013 Dec]. Available from: http://reference.medscape.com/drug/curosurf-poractant-alfa-343453
[15]. Beractant. [internet]. Medscape reference for drugs. [homepage on internet]. [updated 2013; cited 2013 Dec]. Available from: http://reference.medscape.com/drug/survanta-beractant-343452
[16]. Moya FR, Gadzinowski J, Bancalari E, Salinas V, Kopelman B, Bancalari A, Kornacka MK, Merritt TA, Segal R, Schaber CJ, Tsai H, Massaro J, d'Agostino R;International Surfaxin Collaborative Study Group. A Multicenter, Randomized, Masked, Comparison Trial of Lucinactant, Colfosceril Palmitate, and Beractant for the Prevention of Respiratory Distress Syndrome Among Very Preterm Infants Pediatrics. 2005. 115 P.
[17]. Guardia ACG, Moya FR, Sinha S, Simmons PD, Segal R , Greenspan JS. A Pharmacoeconomic Analysis of In-Hospital Costs Resulting from Reintubation in Preterm Infants Treated with Lucinactant, Beractant, or Poractant. J Pediatr Pharmacol Ther. 2012. 17 P.
[18]. Zhu Y, Chidekel A, Shaffer TH. Cultured Human Airway Epithelial Cells (Calu-3): A Model of Human Respiratory Function, Structure, and Inflammatory Responses. Crit Care Res Pract. 2010.
[19]. Discovery Labs Receives FDA Guidance Regarding Pathway to Potential SURFAXIN® Approval Warrington, PA. 2010.
[20]. Guardia CG, Moya FR, Sinha S, Gadzinowski J, Donn SM, Simmons P, Segal R. Reintubation and risk of morbidity and mortality in preterm infants after surfactant therapy. J Neonatal Perinatal Med. 2011. 4:101-109 P.
[21]. Zhu Y, Miller TL, Chidekel AC, Shaffer TH. KL4-surfactant (Surfaxin) protects human airway epithelium from hyperoxia. Pediatr Res. 2008; 64:154-158.
[22]. Ramanathan R, Rasmussen MR, Gerstmann DR, Finer N, Sekar K. A randomized, multicenter masked comparison trial of poractant alfa (Curosurf) versus beractant (Survanta) in the treatment of respiratory distress syndrome in preterm infants. Am J Perinatol. 2004. 21(3):109–119 P.
[23]. Yousuf R. and Abbas A. The Pharmacotherapy of Neonatal Respiratory Distress Syndrome (NRDS): A Review. Inter. J. of Pharmacotherapy. 2014. 4(2): 62-64 P.
References
[1]. Engle WA. Surfactant-Replacement Therapy for Respiratory Distress in the Preterm and Term Neonate. Pediatrics. 2008. 121:419 P.
[2]. American Academy of Pediatrics, Committee on Fetus and Newborn. Surfactant replacement therapy for respiratory distress syndrome. Pediatrics. 1999. 103(3):684–685 P.
[3]. Saigal S, Pinelli J, Hoult L, Kim MM, Boyle M. Psychopathology and social competencies of adolescents who were extremely low birth weight. Pediatrics. 2003. 111:969–975 P.
[4]. Avery ME, Mead J. Surface properties in relation to atelectasis and hyaline membrane disease. AMA J Dis Child. 1959. 97:517-523 P.
[5]. Fujiwara T, Maeta H, Chida S, Morita T, Watabe Y, Abe T. Artificial surfactant therapy in hyaline-membrane disease. Lancet. 1980. 12:1(8159):55–59 P..
[6]. Ramanthan R, Kamholz K, Fujii AM .Is there a Difference in Surfactant Treatment of Respiratory Distress Syndrome in Premature Neonates? A Review. J Pulmon Resp Med. 2013. 813 P.
[7]. [Newsletter]. Discovery Labs Announces FDA Approval of SURFAXIN® (lucinactant) for Prevention of Respiratory Distress Syndrome. [Conference call]. Available from http://www.prnewswire.com/news-releases/discovery-labs-announces-fda-approval-of-surfaxin-lucinactant-for-prevention-of-respiratory-distress-syndrome-141639603.html
[8]. Ma CC, Ma S. The Role of Surfactant in Respiratory Distress Syndrome. Open Respir Med J. 2012. 6: 44-53 P.
[9]. Moen MD, Perry CM, Wellington K. Lucinactant; in Neonatal Respiratory Distress Syndrome. Treat Respir Med. 2005. 4:139-145 P.
[10]. Wolfson MR, Wu J, Hubert TL, Gregory TJ, Mazela J, Shaffer TH. Lucinactant attenuates pulmonary inflammatory response, preserves lung structure, and improves physiologic outcomes in a preterm lamb model of RDS. Pediatr Res. 2012. 72:375-381 P.
[11]. Gilliard N, Richman PM, Merritt TA, Spragg RG. Effect of volume and dose on the pulmonary distribution of exogenous surfactant administered to normal rabbits or to rabbits with oleic acid lung injury. Am Rev Respir Dis. 1990. 141:743–747 P.
[12]. Terry MH, Merritt TA, Harding B, Schroeder H, Merrill-Henry J, Mazela J, Gregory TJ, Segal R, Power GG, Blood AB. Pulmonary distribution of lucinactant and poractant alfa and their peridosing hemodynamic effects in a preterm lamb model of respiratory distress syndrome. Pediatr Res. 2010. 68:193–198 P.
[13]. Kerry L. Dechant, Diana Faulds. Colfosceril Palmitate. Drugs November 1991. 42:877-894 P.
[14]. Poractant alfa. [internet]. Medscape reference for drugs. [homepage on internet]. [updated 2013; cited 2013 Dec]. Available from: http://reference.medscape.com/drug/curosurf-poractant-alfa-343453
[15]. Beractant. [internet]. Medscape reference for drugs. [homepage on internet]. [updated 2013; cited 2013 Dec]. Available from: http://reference.medscape.com/drug/survanta-beractant-343452
[16]. Moya FR, Gadzinowski J, Bancalari E, Salinas V, Kopelman B, Bancalari A, Kornacka MK, Merritt TA, Segal R, Schaber CJ, Tsai H, Massaro J, d'Agostino R;International Surfaxin Collaborative Study Group. A Multicenter, Randomized, Masked, Comparison Trial of Lucinactant, Colfosceril Palmitate, and Beractant for the Prevention of Respiratory Distress Syndrome Among Very Preterm Infants Pediatrics. 2005. 115 P.
[17]. Guardia ACG, Moya FR, Sinha S, Simmons PD, Segal R , Greenspan JS. A Pharmacoeconomic Analysis of In-Hospital Costs Resulting from Reintubation in Preterm Infants Treated with Lucinactant, Beractant, or Poractant. J Pediatr Pharmacol Ther. 2012. 17 P.
[18]. Zhu Y, Chidekel A, Shaffer TH. Cultured Human Airway Epithelial Cells (Calu-3): A Model of Human Respiratory Function, Structure, and Inflammatory Responses. Crit Care Res Pract. 2010.
[19]. Discovery Labs Receives FDA Guidance Regarding Pathway to Potential SURFAXIN® Approval Warrington, PA. 2010.
[20]. Guardia CG, Moya FR, Sinha S, Gadzinowski J, Donn SM, Simmons P, Segal R. Reintubation and risk of morbidity and mortality in preterm infants after surfactant therapy. J Neonatal Perinatal Med. 2011. 4:101-109 P.
[21]. Zhu Y, Miller TL, Chidekel AC, Shaffer TH. KL4-surfactant (Surfaxin) protects human airway epithelium from hyperoxia. Pediatr Res. 2008; 64:154-158.
[22]. Ramanathan R, Rasmussen MR, Gerstmann DR, Finer N, Sekar K. A randomized, multicenter masked comparison trial of poractant alfa (Curosurf) versus beractant (Survanta) in the treatment of respiratory distress syndrome in preterm infants. Am J Perinatol. 2004. 21(3):109–119 P.
[23]. Yousuf R. and Abbas A. The Pharmacotherapy of Neonatal Respiratory Distress Syndrome (NRDS): A Review. Inter. J. of Pharmacotherapy. 2014. 4(2): 62-64 P.
[2]. American Academy of Pediatrics, Committee on Fetus and Newborn. Surfactant replacement therapy for respiratory distress syndrome. Pediatrics. 1999. 103(3):684–685 P.
[3]. Saigal S, Pinelli J, Hoult L, Kim MM, Boyle M. Psychopathology and social competencies of adolescents who were extremely low birth weight. Pediatrics. 2003. 111:969–975 P.
[4]. Avery ME, Mead J. Surface properties in relation to atelectasis and hyaline membrane disease. AMA J Dis Child. 1959. 97:517-523 P.
[5]. Fujiwara T, Maeta H, Chida S, Morita T, Watabe Y, Abe T. Artificial surfactant therapy in hyaline-membrane disease. Lancet. 1980. 12:1(8159):55–59 P..
[6]. Ramanthan R, Kamholz K, Fujii AM .Is there a Difference in Surfactant Treatment of Respiratory Distress Syndrome in Premature Neonates? A Review. J Pulmon Resp Med. 2013. 813 P.
[7]. [Newsletter]. Discovery Labs Announces FDA Approval of SURFAXIN® (lucinactant) for Prevention of Respiratory Distress Syndrome. [Conference call]. Available from http://www.prnewswire.com/news-releases/discovery-labs-announces-fda-approval-of-surfaxin-lucinactant-for-prevention-of-respiratory-distress-syndrome-141639603.html
[8]. Ma CC, Ma S. The Role of Surfactant in Respiratory Distress Syndrome. Open Respir Med J. 2012. 6: 44-53 P.
[9]. Moen MD, Perry CM, Wellington K. Lucinactant; in Neonatal Respiratory Distress Syndrome. Treat Respir Med. 2005. 4:139-145 P.
[10]. Wolfson MR, Wu J, Hubert TL, Gregory TJ, Mazela J, Shaffer TH. Lucinactant attenuates pulmonary inflammatory response, preserves lung structure, and improves physiologic outcomes in a preterm lamb model of RDS. Pediatr Res. 2012. 72:375-381 P.
[11]. Gilliard N, Richman PM, Merritt TA, Spragg RG. Effect of volume and dose on the pulmonary distribution of exogenous surfactant administered to normal rabbits or to rabbits with oleic acid lung injury. Am Rev Respir Dis. 1990. 141:743–747 P.
[12]. Terry MH, Merritt TA, Harding B, Schroeder H, Merrill-Henry J, Mazela J, Gregory TJ, Segal R, Power GG, Blood AB. Pulmonary distribution of lucinactant and poractant alfa and their peridosing hemodynamic effects in a preterm lamb model of respiratory distress syndrome. Pediatr Res. 2010. 68:193–198 P.
[13]. Kerry L. Dechant, Diana Faulds. Colfosceril Palmitate. Drugs November 1991. 42:877-894 P.
[14]. Poractant alfa. [internet]. Medscape reference for drugs. [homepage on internet]. [updated 2013; cited 2013 Dec]. Available from: http://reference.medscape.com/drug/curosurf-poractant-alfa-343453
[15]. Beractant. [internet]. Medscape reference for drugs. [homepage on internet]. [updated 2013; cited 2013 Dec]. Available from: http://reference.medscape.com/drug/survanta-beractant-343452
[16]. Moya FR, Gadzinowski J, Bancalari E, Salinas V, Kopelman B, Bancalari A, Kornacka MK, Merritt TA, Segal R, Schaber CJ, Tsai H, Massaro J, d'Agostino R;International Surfaxin Collaborative Study Group. A Multicenter, Randomized, Masked, Comparison Trial of Lucinactant, Colfosceril Palmitate, and Beractant for the Prevention of Respiratory Distress Syndrome Among Very Preterm Infants Pediatrics. 2005. 115 P.
[17]. Guardia ACG, Moya FR, Sinha S, Simmons PD, Segal R , Greenspan JS. A Pharmacoeconomic Analysis of In-Hospital Costs Resulting from Reintubation in Preterm Infants Treated with Lucinactant, Beractant, or Poractant. J Pediatr Pharmacol Ther. 2012. 17 P.
[18]. Zhu Y, Chidekel A, Shaffer TH. Cultured Human Airway Epithelial Cells (Calu-3): A Model of Human Respiratory Function, Structure, and Inflammatory Responses. Crit Care Res Pract. 2010.
[19]. Discovery Labs Receives FDA Guidance Regarding Pathway to Potential SURFAXIN® Approval Warrington, PA. 2010.
[20]. Guardia CG, Moya FR, Sinha S, Gadzinowski J, Donn SM, Simmons P, Segal R. Reintubation and risk of morbidity and mortality in preterm infants after surfactant therapy. J Neonatal Perinatal Med. 2011. 4:101-109 P.
[21]. Zhu Y, Miller TL, Chidekel AC, Shaffer TH. KL4-surfactant (Surfaxin) protects human airway epithelium from hyperoxia. Pediatr Res. 2008; 64:154-158.
[22]. Ramanathan R, Rasmussen MR, Gerstmann DR, Finer N, Sekar K. A randomized, multicenter masked comparison trial of poractant alfa (Curosurf) versus beractant (Survanta) in the treatment of respiratory distress syndrome in preterm infants. Am J Perinatol. 2004. 21(3):109–119 P.
[23]. Yousuf R. and Abbas A. The Pharmacotherapy of Neonatal Respiratory Distress Syndrome (NRDS): A Review. Inter. J. of Pharmacotherapy. 2014. 4(2): 62-64 P.