Mallinckrodt enrolls first infant in registry for inhaled nitric oxide gas

Mallinckrodt Pharmaceuticals (NYSE:MNK) said today that it included the first patient in its Phase IV registry evaluating the use of inhaled Inomax nitric oxide gas for premature neonates compared to term and near-term newborns.

Inomax, which has FDA approval, is designed to boost oxygenation and lessen the need for extracorporeal membrane oxygenation in term and near-term neonates with hypoxic respiratory failure linked to pulmonary hypertension.

The primary outcome measure of the 168-patient registry is slated to compare the incidence of participants with at least a 25% improvement in oxygenation index or surrogate oxygenation index compared to baseline, according to gestation age group.

Mallinckrodt said it expects the observational registry will be completed by 2022.

Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.

Theranos whistleblower Tyler Shultz to participate in keynote interview at DeviceTalks Boston At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos. Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston. REGISTER NOW