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Omission of Relevant Information of the FDA approved Synthetic Surfactant: Surfaxin

Posted by marlar on 19 Feb 2013 at 14:39 GMT

The article by A. Sato and M. Ikegami entitled "SP-B and SP-C Containing New Synthetic Surfactant for Treatment of Extremely Immature Lamb Lung" possesses a marked deficiency. One immediately questions why the entire body of literature culminating in the recent FDA approval of the synthetic KL4-surfactant was not referenced. Probably the greatest mis-quote appears at the start of the introduction: "Clinical responses to surfactant treatment reveal the superiority of animal-derived surfactant over synthetic surfactant, including Surfaxin and Exosurf...". Surfaxin (KL4-surfactant) has been extensively evaluated in several preclinical and clinical trials which have demonstrated physiologic, clinical, and pharmacoeconomic outcome comparability and, in some cases, clear superiority to currently available animal derived surfactants, beractant, and poractant alfa. The most relevant peer-reviewed publications relating to KL4-surfactant development are cited below for your readership's reference (1-6). We are concerned that, because of this omission, the article fails to reflect recent, significant advancements using the synthetic surfactant, Surfaxin, that we firmly believe will lead to clinical improvement in the management of neonatal RDS.

We eagerly await your response.

Sincerely,

Charles G. Cochrane, M.D.
Professor Emeritus
The Scripps Research Institute

T. Allen Merritt, M.D., M.H.A.
Professor of Pediatrics
Loma Linda University Children’s Hospital

Marla R. Wolfson, M.S., Ph.D.
Professor of Pediatrics, Physiology, and Medicine
Temple University School of Medicine

REFERENCES:

1. A Multicenter, Randomized, Masked, Comparison Trial of Lucinactant, Colfosceril Palmitate, and Beractant for the Prevention of Respiratory Distress Syndrome Among Very Preterm Infants. Moya FR, Gadzinowski J, Bancalari E, Salinas V, Kopelman B, Bancalari A, Katarzyna Kornacka M, Merritt TA, Segal R, Schaber CJ, Tsai H, Massaro J, d’Agostino R, for the International Surfaxin Collaborative Study Group. Pediatrics 2005; 115: 1018-1029.

2. A Multicenter, Randomized, Controlled Trial of Lucinactant Versus Poractant Alfa Among Very Premature Infants at High Risk for Respiratory Distress Syndrome. Sinha SK, Lacaze-Masmonteil T, Valls i Soler A, Wiswell TE, Gadzinowski J, Hajdu J, Bernstein G, Sanchez-Luna M, Segal R, Schaber CJ, Massaro J, d’Agostino R, and for the Surfaxin Therapy Against Respiratory Distress Syndrome Collaborative Group. Pediatrics 2005; 115: 1030-1038

3. One-Year Follow-up of Very Preterm Infants Who Received Lucinactant for Prevention of Respiratory Distress Syndrome: Results From 2 Multicenter Randomized, Controlled Trials. Moya FR, Sinha S, Gadzinowski J, D'Agostino R, Segal R, Guardia CG, Mazela J, Liu G and on behalf of the SELECT and STAR Study Investigators. Pediatrics 2007;119;e1361-e1370; originally published online May 28, 2007; DOI: 10.1542/peds.2006-0149. Department of Neonatology, Coastal Area Health Education Center, Wilmington, North Carolina; Department of Pediatrics, James Cook University Hospital, Middlesbrough, United Kingdom; Department of Neonatology, University of Medical Sciences, Poznan, Poland; Department of Neonatology, Mother’s Memorial Hospital Research Institute, Lodz, Poland; Department of Mathematics, Boston University, Boston, Massachusetts; Medical Affairs, Discovery Laboratories, Inc, Warrington, Pennsylvania.

4. Reintubation and risk of morbidity and mortality in preterm infants after surfactant replacement therapy. Guardia GC, Moya FR, Sinha, S, Gadzinowski J, Donn SM, Simmons P, Segal R. J Neonat- Perinat Med 2011;4:101-109 Centro de Investigaci´on Perinatal, Universidad de Chile, Santiago, Chile, South East Area Health Education Center, Department of Neonatology, Wilmington, NC, USA, James Cook University Hospital, Middlesbrough, UK, University of Medical Sciences, Poznan, Poland, and Polish Mother’s Memorial Hospital Research Institute, Lodz, Poland, Division of Neonatal-Perinatal Medicine, University of Michigan Health System, Ann Arbor, MI, USA, Discovery Laboratories, Inc., Warrington, PA, USA.

5. A Pharmacoeconomic Analysis of In-Hospital Costs Resulting from Reintubation in Preterm Infants Treated with Lucinactant, Beractant, or Poractant Alfa. Guardia CG, Moya FR, Sinha S, Simmons P, Segal R, Greenspan JS. J Pediatr Pharmacol Ther 2012;17(3):158–165. Centro de Investigación Perinatal, Universidad de Chile, Santiago, Chile, Discovery Laboratories, Inc., Warrington, Pennsylvania, Betty Cameron Women & Children’s Hospital, Coastal Carolina Neonatology, Wilmington, North Carolina, James Cook University Hospital, Middlesbrough, United Kingdom, Thomas Jefferson University, Nemours/ A.I. DuPont Hospital for Children, Wilmington, Delaware

6. Lucinactant attenuates pulmonary inflammatory response, preserves lung structure, and improves physiologic outcomes in a preterm lamb model of RDS. Wolfson MR, Wu J, Hubert TL, Gregory TJ, Mazela J, Shaffer TH. Pediatr Res. 2012 Oct;72(4):375-83. doi: 10.1038/pr.2012.96. Epub 2012 Jul 20. Department of Physiology, Temple University School of Medicine, Philadelphia, Pennsylvania, USA. marla.wolfson@temple.edu

Competing interests declared: Charles G. Cochrane, M.D.is the inventor of the synthetic peptide surfactant, Surfaxin, made by the KL4-peptide and phospholipids. He is also a founder of the company, Discovery Laboratories, that carried Surfaxin through Phase 3 clinical trials and obtained approval by the FDA in March of 2012. He is a consultant for Discovery Labs and owns a small number of shares of stock in the company.

T. Allen Merritt, M.D., M.H.A. has no financial conflict of interest.

Marla R. Wolfson, M.S., Ph.D. has participated in research through grant funding from Discovery Laboratories, Inc. to Temple University and has no financial conflict of interest.

RE: Omission of Relevant Information of the FDA approved Synthetic Surfactant: Surfaxin

mikegami replied to marlar on 19 Feb 2013 at 20:56 GMT

Thank you for your comments on our paper entitled "SP-B and SP-C containing new synthetic surfactant for treatment of extremely immature lamb lung". There is a timing issue when our paper was accepted and KL-4 surfactant was approved by FDA. This paper was submitted over one year ago and published in May 2012. At which time, the KL-4 surfactant was not commercially available and your study of KL-4 surfactant treatment on preterm lamb has not been published.(your ref #6,published on Oct 2012).Therefore, we did not discussed only KL-4 surfactant, but explained synthetic surfactant as a group.
Sincerely,
Machiko Ikegami MD PhD

No competing interests declared.