Mallinckrodt Evaluates the Potential Role for Inhaled Nitric Oxide to Treat COVID-19 Associated Lung Complications, Engages with Scientific, Governmental and Regulatory Agencies
STAINES-UPON-THAMES, United Kingdom, March 12, 2020 /PRNewswire/ -- Mallinckrodt Pharmaceuticalsplc (NYSE: MNK), a global biopharmaceutical company, today commented that it is currently evaluating the limited published evidence suggesting a potential role for inhaled nitric oxide ("iNO") as a supportive measure in treating those patients infected with coronavirus (SARS-CoV-2) and having associated pulmonary complications. The company has engaged with the U.S. Food and Drug Administration (FDA), the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA) on this matter; however, the safety and efficacy of iNO for pulmonary complications associated with coronavirus have not been established.
Mallinckrodt markets iNO as INOmax® (nitric oxide) gas for inhalation in the U.S. for the treatment of term and near-term neonates with hypoxic respiratory failure associated with pulmonary hypertension. Please see Important Safety Information below.
While nitric oxide has not been specifically studied or used to treat COVID-19, in vitro it has demonstrated an inhibitory effect on the replication cycle of severe acute respiratory syndrome-related coronavirus (SARS-CoV).1 In another study, investigators utilized iNO in the treatment of six patients infected with SARS-CoV. This study compared the outcomes of the six patients treated with iNO to eight controls. Improvements in blood oxygenation, a reduction in supplemental oxygen and a reduction in the amount of ventilator support were achieved.2
A potential clinical manifestation of infection with many respiratory viruses (such as coronaviruses or influenzas) is acute respiratory distress syndrome (ARDS) - a disorder in which fluid leaks into the lungs, making breathing difficult or impossible. iNO has been evaluated in randomized controlled trials, both in pediatric and adult patients with ARDS.3-7 In one study, iNO elicited a partially dose dependent improvement in blood oxygenation and decreased pulmonary artery pressure.3 In a second trial, evaluating pediatric ARDS patients, improvements were found in the composite measure of days alive or free of ventilator support at day 28 of the trial (the last day evaluated).8 There have been other trials evaluating iNO in the context of ARDS, which have demonstrated mixed results.9
In recent days, the company has submitted information to the NIH regarding the potential to evaluate iNO in ARDS, informed BARDA of the ongoing evaluation in this area and is in early discussions with the FDA on the potential to submit a pre-Investigational New Drug (IND) package in support of the potential use of iNO in coronavirus-associated ARDS.
"Mallinckrodt is evaluating the limited data presently available on inhaled nitric oxide as a supportive measure for treating coronavirus-associated lung complications," said Steve Romano, M.D., Executive Vice President and Chief Scientific Officer at Mallinckrodt. "We are in ongoing discussions with scientific, regulatory and governmental organizations regarding the potential use of iNO in assisting with this global emergency, and are committed to determining whether iNO has a benefit for those diagnosed with COVID-19. We will share updates as information becomes available."
IMPORTANT SAFETY INFORMATION
Please see Full Prescribing Information.
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