MannKind has confirmed the design of two clinical studies with the US Food and Drug Administration (FDA) to evaluate the safety and efficacy of drug-device combination product Afrezza, administered using MannKind's proprietery inhaler.
Afrezza is an ultra rapid acting mealtime insulin therapy is used to treat adult patients with type 1 or type 2 diabetes for the control of hyperglycemia.
It is a drug-device combination product, consisting of Afrezza Inhalation Powder pre-metered into single use dose cartridges and Afrezza Inhaler.
Previously, the FDA has asked MannKind to conduct two clinical trials with the company’s inhaler in patients with type 1 and type 2 diabetes.
The agency asked MannKind to treat a group in one of the trial with the previously studied MedTone inhaler to get a comparison of the pulmonary safety data for the two devices.
The first Study 171 trial will assess Afrezza in patients suffering from type 1 diabetes and the second trial will assess Afrezza using the next-generation inhaler in patients with type 2 diabetes who are inadequately controlled on metformin with or without a second or third oral medication.
MannKind chairman and CEO Alfred Mann said the protocol for Study 171 has already been sent to Institutional Review Boards and the protocol for Study 174 is being finalized and will be distributed to our sites shortly.