Afrezza® Safety and Pharmacokinetics Study in Pediatric Patients Opens Enrollment for Cohort 3
An interim review of data from individuals participating in the second cohort shows that the single‑dose pharmacokinetic profile of insulin levels for this age group is consistent with the pattern seen in adults. In addition, dosing over one month demonstrated a safety profile that was also consistent with that observed in adults. As a result of these findings,
This third and final cohort will study Afrezza in children aged 4-7 years and will assess insulin levels, glucose changes, and the short-term safety and tolerability of multiple doses of Afrezza.
“We are very pleased that we can extend the study to younger children who could benefit from the flexible dosing Afrezza provides and thankful for the families and investigators who have participated to date,” said David Kendall, M.D., Chief Medical Officer of MannKind.
For additional information about the study, please contact John Krueger, Vice President,
Available by prescription, Afrezza® (insulin human) Inhalation Powder is a rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus. Afrezza consists of a dry powder formulation of human insulin delivered from a small and portable inhaler. Administered at the beginning of a meal, Afrezza dissolves rapidly upon inhalation to the lung and passes quickly into the bloodstream (in less than one minute). This rapid absorption allows Afrezza to begin reducing blood sugar levels within minutes of administration. Afrezza is available in 4-unit, 8-unit and 12-unit single-dose cartridges of insulin powder that can be used, as prescribed by a health care professional, in combination with other diabetes medications to achieve target blood sugar levels. For Afrezza doses exceeding 12 units, patients may use a combination of existing cartridge strengths. For more information about Afrezza, please visit www.afrezza.com.
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