After a meeting with the FDA, MannKind Corporation has announced that the company and the agency have confirmed protocols for new efficacy and safety studies of Afrezza inhaled insulin. The original studies of Afrezza were conducted with MedTone inhaler, and in May, the FDA asked MannKind to conduct new trials with the new Dreamboat inhaler in patients with type 1 diabetes and in patients with type 2 diabetes, including a head-to-head comparison.
Alfred Mann, MannKind’s Chairman and CEO, said, “We are very encouraged and pleased with this outcome. Our attention now turns to the execution of these trials. 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.”
Study 171 will compare the MedTone and Dreamboat devices in patients with type 1 diabetes, and Study 174 will look at the efficacy of Afrezza delivered by the Dreamboat DPI in patients with type 2 diabetes who have inadequate control on metformin. Both studies will have a titration period followed by a 12-week observation period.
Read the MannKind press release.
