FDA Actions
August 1, 2014
The FDA has approved a new inhaled insulin. Human insulin Inhalation Powder is a rapid-acting insulin used to improve glycemic control in adults with type 1 and type 2 diabetes. The drug is to be used at mealtime and is not a substitute for long-acting insulin. The drug was approved on the strength of studies of more than 3000 patients, of which one-third were type 1 diabetics and two-thirds were type 2 diabetics. For type 1 diabetics, inhaled insulin was non-inferior to insulin aspart when combined with a long-acting insulin, although HbA1c was significantly higher with inhaled insulin compared to aspart. For type 2 diabetics, inhaled insulin was combined with an oral agent and compared to a placebo inhaled agent plus an oral agent. By 24 weeks, inhaled insulin showed a significantly greater reduction in HbA1c than placebo. Inhaled insulin comes with a boxed warning regarding risk of acute bronchospasm in patients with asthma and chronic obstructive pulmonary disease. The warning also states that the drug should not be used in patients with chronic lung disease. The warning further states that spirometry should be performed prior to starting inhaled insulin, as well as 6 months into therapy and every year thereafter. The drug is also approved with a Risk Evaluation and Mitigation Strategy requiring a plan to inform health care professionals about the risk of bronchospasm. Insulin inhalation powder is manufactured and marketed by MannKind Corporation as Afrezza. This product is the second inhaled insulin after Exubera, which was approved in 2006, but then removed from the market in 2007 due to poor sales.
The FDA has approved a new topical agent for treating toenail fungus (onychomycosis). Tavaborole 5% is applied daily for 48 weeks. It was approved on the basis of two trials of nearly 1200 patients who did not have lunula involvement showing a 7-9% complete cure rate at 1 year compared to a 0.5-1.5% cure rate for placebo. Tavaborole will be marketed by Anacor Pharmaceuticals as Kerydin.
The FDA has issued a Consumer Alert about powdered pure caffeine that is being marketed directly to consumers over the Internet. The product is sold in bulk bags and contains pure powdered caffeine, with each teaspoon containing the equivalent amount of caffeine found in 25 cups of coffee. There has been one reported death of an Ohio teenager who used these products. Powdered caffeine is becoming increasingly popular with teens and young adults who see it as an inexpensive form of caffeine with a quick onset of action. Overdose can cause tachycardia, seizures, nausea, diarrhea, stupor, disorientation, and death. The FDA recommends avoiding powdered pure caffeine and reporting adverse effects to its hotline at [email protected].
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