Regulators Recommend Approval of Insulin Spray

An advisory panel is recommending that the United States Food and Drug Association approve an insulin delivery system that works like an inhaler, quickly and effectively delivering insulin to diabetics without a need of injection.

The inhalable insulin -- called Afrezza -- is reportedly not as efficient as injected insulin in the treatment of diabetics, as it comes in smaller doses in the interest of safety, However, trail testing of the product has shown that inhaled insulin is "rapid-acting" insulin that reportable takes a much faster effect on a diabetic's body than the leading injected insulin.

According to the FDA advisory committee's acting chairman, Dr. Robert Smith, Afrezza, developed by MannKind Corp.,  offers an alternative form of treatment for diabetics who "are not effectively served by currently available insulin."

The advisory committee met on Monday to discuss the effectiveness and safety of Afrezza and its delivery devices, called the "Dreamboat" and the "MedTone."

Prior reports had been skeptical about the potential for a positive committee decision, after federal regulators revealed earlier last week that they still held concerns about the safety of the inhalable insulin, citing past studies that had rereleased that a tiny portion of past trial participants that taken the treatment later developed lung cancer.

However, after discussing these safety concerns, the advisory committee reported on Tuesday that the benefits of the treatment outweigh the potential of risks, citing the testimony of FDA investigators who had chalked up the cases of lung-cancer to unrelated and natural causes.

The FDA has been very cautious about approving Afrezza in the past. MannKind has been trying to obtain federal approval for the inhalable insulin and its delivery devices since 2009. The treatment was denied approval in two previous attempts with the FDA asking for more clinical trials to ensure the safety of Afrezza.

Even with the approval of the advisory board, it should be noted that there is still a chance that the FDA will not approve the treatment, as the FDA is not required to follow the recommendations of its advisory panels.

MannKind released a press release revealing the advisory panel's decision on April 1.