To Continue from our recent discussion on Blood sugar, diabetes and insulin ( http://tnmgc.com/discus/viewtopic.php?f=30&t=481 ) we were delighted to hear today the launch of a new drug for diabetes. Afrezza an Insulin inhalation powder that may replace Insulin injections very soon!

This Press release was issued on June 27, 2014 and modified on June 30, 2014.
The U.S. Food and Drug Administration today approved Afrezza (insulin human) Inhalation Powder, a rapid-acting inhaled insulin to improve glycemic control in adults with diabetes mellitus. Afrezza is a rapid-acting inhaled insulin that is administered at the beginning of each meal.

Afrezza (insulin human [rDNA origin] Inhalation Powder) is an ultra rapid acting insulin product that has completed Phase 3 trials. The pharmacokinetic profile of Afrezza sets it apart from all other insulin products. The large surface area of the lung provides unique access to the circulatory system. The pH-sensitive Afrezza particles immediately dissolve upon contact with the lung surface, releasing insulin monomers that rapidly enter the bloodstream. It achieves peak insulin levels within 12-14 minutes of administration, effectively mimicking the release of meal-time insulin observed in healthy individuals, but which is absent from patients with diabetes.

The drug’s safety and effectiveness were evaluated in a total of 3,017 participants–1,026 participants with type 1 diabetes and 1,991 patients with type 2 diabetes. The efficacy of mealtime Afrezza in adult patients with type 1 diabetes patients was compared to mealtime insulin as part (fast-acting insulin), both in combination with basal insulin (long-acting insulin) in a 24 week study. At week 24, treatment with basal insulin and mealtime Afrezza provided a mean reduction in HbA1c that met the pre-specified non-inferiority margin of 0.4 percent. Afrezza provided less HbA1c reduction than insulin aspart, and the difference was statistically significant. Afrezza was studied in adults with type 2 diabetes in combination with oral antidiabetic drugs; the efficacy of mealtime Afrezza in type 2 diabetes patients was compared to placebo inhalation in a 24 week study. At week 24, treatment with Afrezza plus oral antidiabetic drugs provided a mean reduction in HbA1c that was statistically significantly greater compared to the HbA1c reduction observed in the placebo group.

Afrezza is not a substitute for long-acting insulin. Afrezza must be used in combination with long-acting insulin in patients with type 1 diabetes, and it is not recommended for the treatment of diabetic ketoacidosis, or in patients who smoke.

Acute bronchospasm has been observed in patients with asthma and chronic obstructive pulmonary disease (COPD). Afrezza should not be used in patients with chronic lung disease, such as asthma or COPD because of this risk. The most common adverse reactions associated with Afrezza in clinical trials were hypoglycemia, cough, and throat pain or irritation.
The FDA approved Afrezza with a Risk Evaluation and Mitigation Strategy, which consists of a communication plan to inform health care professionals about the serious risk of acute bronchospasm associated with Afrezza.

Afrezza is manufactured by MannKind Corporation, Danbury, Connecticut.

Badri.