– Medical chart review study, published in Drugs in Context, evaluated the real-world use of INOmax® (nitric oxide) gas, for inhalation in hospitalized COVID-19 patients with mild-to-moderate acute respiratory distress syndrome (ARDS) in the
INOmax has been on the market in the
The safety and efficacy of INOmax to treat COVID-19 have not been evaluated, established or approved for use by the
The retrospective, observational medical chart review study included patients who were at least 18 years old at the time of hospitalization, hospitalized for COVID-19, met the
"These findings of INOmax use in clinical practice may help us gain an understanding of the real-world use of different potential treatment approaches and outcomes in people suffering from mild-to-moderate ARDS, a historically understudied population," said
The data analysis found that when response was defined as an increase in P/F ratio by >20 percent at any time after INOmax initiation, nearly two-thirds of patients (n=23; 62.2 percent) achieved response to INOmax. Additionally, mean P/F ratio (standard deviation) increased from 136.7 (34.4) at baseline to 140.3 (53.2) at 48 hours and 151.8 (50.0) at 72 hours after INOmax initiation (N=34). Median time to response was 3 days (interquartile range 1 to 3 days) after initiation of INOmax. In a sensitivity analysis, when response was defined as a ˃10 percent increase in P/F ratio, most (n=26; 70.3 percent) patients were categorized as responders. Among the 27 patients (73 percent) receiving invasive mechanical ventilation at the time of INOmax initiation, 4 (14.8 percent) were transitioned to non-invasive ventilation. No patient required extracorporeal membrane oxygenation (ECMO) after initiating INOmax. Data on select adverse events of interest were also collected (methemoglobinemia, airway injury and worsening pulmonary edema) and none were attributed to INOmax treatment. At discharge, 20 patients (54 percent) improved or remained stable according to the Clinical Global Impression–Improvement (CGI-I) scores.2
Study limitations include the retrospective nature of the study design and the use of data abstracted from medical charts of study patients. The accuracy and completeness of data in this study are limited by the availability and quality of data in each patient's medical chart. Treatment patterns in the study reflect the use of INOmax for hospitalized COVID-19 patients in selected medical centers willing to participate in this retrospective medical chart study and may not be representative of all institutions using INOmax. The dosing and duration of INOmax treatment was variable across sites and determined at the attending physician's discretion. Criteria for initiation of INOmax, INOmax weaning and weaning protocols were not standardized across sites. Detailed information was not collected about all potential interventions for the acute management of COVID-19 ARDS, including diuretics, vasopressors and prone positioning. Future randomized, placebo-controlled studies are needed to determine potential efficacy, safety and place in therapy. Due to the retrospective nature of this analysis, it is hypothesis-generating; no formal conclusions should be drawn.
"The results of this retrospective medical chart review analysis support the importance of continued collection of real-world data to help expand our understanding of the investigational use and potential of INOmax," said
In severe cases, COVID-19 can cause acute respiratory distress syndrome (ARDS), a major cause of morbidity and mortality in patients with COVID-19.3,4
The study was funded by Mallinckrodt.
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CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This release includes forward-looking statements concerning inhaled nitric oxide ("iNO") and the Company's INOmax product, including statements with regard to the potential impact of iNO on patients and anticipated benefits associated with its use. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues; and other risks identified and described in more detail in the "Risk Factors" section of Mallinckrodt's most recent Annual Report on Form 10-K and other filings with the
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1 Ranieri VM, Rubenfeld GD, Thompson BT, et al. Acute respiratory distress syndrome: the Berlin Definition. JAMA.
2 Abman SH, Fox NR, Malik MI, et al. Real-world use of inhaled nitric oxide therapy in patients with COVID-19 and mild-to-moderate acute respiratory distress syndrome. Drugs in Context. 2022;11:2022-1-4. https://doi.org/10.7573/dic.2022-1-4.
3 Adusumilli NC, Zhang D, Friedman JM, Friedman AJ. Harnessing nitric oxide for preventing, limiting and treating the severe pulmonary consequences of COVID-19. Nitric Oxide.
4 Matthay MA, Aldrich JM,
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