Mallinckrodt INOmax (nitric oxide) product is already approved by the US Food and Drug Administration (FDA) 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.
INOmax is a vasodilator that opens blood vessels, allowing for improved oxygen uptake and blood flow. It is currently approved for use in conjunction with ventilatory support and other appropriate agents.
The 510(k) application would see the product be administered in an updated delivery system, which would be an inhaled nitric oxide, dual channel delivery system.
According to the company, the new delivery technology would combine automation, interaction and integration in one device. The safety and efficacy of the new form of delivery has not yet been evaluated by the FDA.
In 2020, the Agency found that the company’s INOmax DSIR Plus delivery system was substantially equivalent to available devices and therefore gave the company the right to market the product. This delivery device delivered the INOmax gas through an inspiratory limb via inhalation.
If the latest drug delivery system is approved, it would add to Mallinckrodt’s portfolio of formulation and drug delivery technologies. According to the company, it possesses abuse-deterrent formulation technology and a nanoparticle encapsulation platform, whilst also having experience with solid oral, liquid, parenteral dosage forms, and oral sustained-release dosage forms.
During the height of the pandemic, Mallinckrodt tested its nitric oxide product to determine whether its use could help patients with severe acute respiratory distress syndrome.
The company also funded a study to determine whether it could help patients when “it may be too late to impact disease course.” In the results of the study, it was found that 62% of patients showed an improved P/F ratio (a test to assess the severity of hypoxemia) as a result of treatment, with no toxicity.
Several years ago, Mallinckrodt became one of the leading companies to face legal action over the opioid epidemic that emerged in the US.
The number of lawsuits brought against the company forced it into bankruptcy and, earlier this year, the company agreed to pay $260m (€265m) to resolve allegations that it had underpaid Medicaid drug rebates and on the payment of illegal kickbacks.