Mallinckrodt markets iNO as INOmax® (nitric oxide) gas for inhalation in the
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
"Mallinckrodt is evaluating the limited data presently available on inhaled nitric oxide as a supportive measure for treating coronavirus-associated lung complications," said
INOmax® (nitric oxide) gas, for inhalation, is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.
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Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the company in advance of or in lieu of distributing a press release or a filing with the
CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This release includes forward-looking statements concerning inhaled nitric oxide ("iNO") and the Company's iNO product, including statements with regard to potential regulatory developments, 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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SOURCE Mallinckrodt Pharmaceuticals