One Big Step for Mannkind’s Afrezza Inhaler

August 17th, 2011 by Ryan Luce 1 Comment

written by Michael O’Leary

The FDA has approved clinical trial designs for an inhaled diabetes drug for patients with type 1 diabetes, and people with type 2 diabetes who have been unable to achieve adequate control with metformin.

The drug, trademarked as Afrezza® by MannKind Corporation is an ultra-fast-acting mealtime insulin therapy that uses a pre-metered dose inhaler to deliver insulin in powder form. The drug dissolves immediately upon inhalation and delivers insulin quickly to the blood stream, according to company documents. Peak insulin levels are achieved in 12 to 14 minutes, mirroring the early release of mealtime insulin observed in health individuals. (Link to published site)

Last January, the FDA asked the company to conduct two trials of Afrezza, one in patients with type 1 diabetes, and one in patients with type 2 diabetes. Yesterday the company announced that the FDA had approved the two study designs it had submitted.

Hakan Edstrom, MannKind’s president and chief operating officer told Corengi that as soon as the protocols are finished they will begin enrolling participants.

“The type 1 trial is expected to be ready to begin enrollment by mid-September,” Edstrom said in a phone interview. And we hope the type 2 trial will be ready to begin enrollment by the end of October, or early November.”

In Study 171, patients with type 1 diabetes will be randomly assigned to one of three groups, a comparison group, called a control group that will use currently available injected rapid-acting insulin at mealtimes. The other two groups will use one of two inhalers to administer Afrezza before meals. One inhaler is the company’s MedTone® design, the other is a next-generation device using its Dreamboat™ technology.

In Study 174, patients with type 2 diabetes who have inadequately controlled diabetes will be randomly assigned to a group using Afrezza with the next-generation inhaler with or without a second or third oral medication. Another group will use the next-generation inhaler with a placebo with or without second or third oral medication.

MannKind hopes to succeed where drug giant Pfizer failed with Exubera, the first inhaled insulin administration. The company withdrew the product four years ago following slow sales. The inhaler for Exubera was about the size of a can of tennis balls, which is a lot more unwieldy than a small injection pen. It also carried a risk of lung side effects that also put a damper on acceptance of the product.

MannKind believes it has overcome the cumbersome inhaler problem with its “Dreamboat (Gen2)” inhaler, which easily fits within the palm of a hand. They’ve also developed a single dose cartridge that requires 33 percent less powder to provide comparable systemic insulin exposure.