Mallinckrodt Announces Submission of 510(k) to the U.S. FDA for Inhaled Nitric Oxide Delivery System

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If 510(k) cleared, this next-generation investigational inhaled nitric oxide delivery system would be the latest in a long line of dual channel delivery systems building on Company's dedication to meeting clinicians' evolving needs

DUBLIN, Sept. 28, 2022 -- Mallinckrodt plc (OTCMKTS: MNKPF), a global specialty pharmaceutical company, today announced the submission of a 510(k) premarket notification application to the U.S. Food and Drug Administration (FDA) for an investigational inhaled nitric oxide delivery system for INOmax® (nitric oxide) gas, for inhalation.

The safety and efficacy of the investigational inhaled nitric oxide delivery system has not been evaluated by the FDA.

INOmax® (nitric oxide) gas, for inhalation, is an FDA-approved treatment that 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.1 Please see Important Safety Information for INOmax below.

"This FDA submission marks an important milestone in our commitment to providing advancements in the delivery of our products to help improve clinician experiences," said Steven Romano, M.D., Executive Vice President and Chief Scientific Officer at Mallinckrodt. "We look forward to working closely with the FDA during the regulatory review process."

If 510(k) cleared, the next-generation inhaled nitric oxide delivery system would be the latest in a long line of dual channel delivery systems; would combine automation, integration and interaction in one device; and build on Mallinckrodt's dedication to meeting clinicians' evolving needs.2

INOmax has a well-established efficacy and safety profile with more than 20 years on the market and over 875,000 patients treated globally.1,3

Mallinckrodt is committed to providing support to healthcare professionals utilizing the INOmax delivery systems. Mallinckrodt provides access to INOmax Total Care® offerings whose goal is to help critical care clinicians face unexpected challenges in the NICU by providing comprehensive, 24/7/365 service, device training, and INO delivery support when and where they need it. For more information about INOmax, please visit INOmax.com.

The investigational inhaled nitric oxide delivery system is not available for sale, distribution or use.

INDICATION

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.

IMPORTANT SAFETY INFORMATION

  • INOmax is contraindicated in the treatment of neonates dependent on right-to-left shunting of blood.
  • Abrupt discontinuation of INOmax may lead to increasing pulmonary artery pressure and worsening oxygenation.
  • Methemoglobinemia and NO2 levels are dose dependent. Nitric oxide donor compounds may have an additive effect with INOmax on the risk of developing methemoglobinemia. Nitrogen dioxide may cause airway inflammation and damage to lung tissues.
  • In patients with pre-existing left ventricular dysfunction, INOmax may increase pulmonary capillary wedge pressure leading to pulmonary edema.
  • Monitor for PaO2, inspired NO2, and methemoglobin during INOmax administration.
  • INOmax must be administered using a calibrated FDA-cleared Nitric Oxide Delivery System.

Please see Full Prescribing Information.

Globally, prescribing information varies; refer to the individual country product label for complete information.

ABOUT MALLINCKRODT 

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, hepatology, nephrology, pulmonology, ophthalmology, and oncology; immunotherapy and neonatal respiratory critical care therapies; analgesics; cultured skin substitutes 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 U.S. Securities and Exchange Commission (SEC) disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.

CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS

This release includes forward-looking statements concerning Mallinckrodt's s 510(k) premarket notification application and the Company's inhaled nitric oxide delivery system. 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, Mallinckrodt's Quarterly Report on Form 10-Q for the quarterly period ended July 1, 2022 and other filings with the SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.

CONTACT

Media Inquiries
Heather Guzzi
Senior Vice President, Green Room Communications
973-524-4112
[email protected]

Investor Relations
Daniel J. Speciale
Global Corporate Controller & Chief Investor Relations Officer
314-654-3638
[email protected]

Derek Belz
Vice President, Investor Relations
314-654-3950
[email protected]

Mallinckrodt, the "M" brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. ©2022 Mallinckrodt. US-2200202 09/22

References

1 INOmax. Package Insert. INO Therapeutics LLC; 2021.
2 Data on File - Ref-05943. Mallinckrodt Pharmaceuticals.
3 Data on File - Ref-01753. Mallinckrodt Pharmaceuticals.

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SOURCE Mallinckrodt plc