{"id":47405,"date":"2017-07-20T10:31:17","date_gmt":"2017-07-20T14:31:17","guid":{"rendered":"https:\/\/asweetlife.org\/?p=47405"},"modified":"2017-07-20T10:31:17","modified_gmt":"2017-07-20T14:31:17","slug":"new-easy-to-use-nasal-glucagon-on-the-horizon","status":"publish","type":"post","link":"https:\/\/asweetlife.org\/?p=47405","title":{"rendered":"New Easy to Use Nasal Glucagon On the Horizon"},"content":{"rendered":"

While insulin and insulin pumps have evolved into highly technical and effective tools for treating diabetes, the method for delivering emergency glucagon to save the lives of people with diabetes in the throes of hypoglycemia has remained in the relative Stone Age. Until now.<\/p>\n

A new system from pharmaceutical firm Eli Lilly and Company<\/a> for delivering glucagon in a simple, one-use nasal powder rather than in the existing clunky and complicated system that involves mixing liquid and powder together then injecting the solution is now in the final stages of clinical testing.<\/p>\n

\u201cAsking anyone to mix and inject emergency glucagon the way it\u2019s always been configured is really scary,\u201d says Robert Oringer<\/a>, who as part of the pharmaceutical company Locemia<\/a> was instrumental in developing a new and easier way for family, friends, or any willing person to deliver glucagon rescue to insulin users requiring low blood sugar assistance. \u201cAnd that\u2019s not right because anyone who uses insulin faces the possibility of low blood sugar. They shouldn\u2019t have to worry about being able to get glucagon when they need it. So, we came up with a better way for them to get it.\u201d<\/p>\n

The need to come up with a better system has been apparent for years, even to Lilly, the company that is developing what is called \u201cnasal glucagon\u201d while also owning rights to an existing configuration for delivering glucagon.<\/p>\n

In October 2015, Lilly and Locemia announced that Lilly acquired worldwide rights to Locemia\u2019s nasal glucagon. Lilly then set out to commercialize Locemia\u2019s drug and device, according to a spokesperson for Lilly. Since October 2015, the Lilly team has made progress toward ensuring manufacturing capabilities are in place to distribute\u00a0nasal glucagon worldwide while also preparing for global regulatory submissions. The company expects U.S. regulatory submission to occur in the first half of 2018 and the\u00a0European Union and Canada submission following. These efforts, if successful, will replace a method of glucagon that is badly in need of improvement.<\/p>\n

\u201cThe system as it exists now is very complicated,\u201d says Cristina Guzman, MD, Senior Medical Advisor at Lilly \u201cIt takes eight or nine steps just to administer. Because of that, it\u2019s not as effective as it might otherwise be.\u201d<\/p>\n

Guzman should know how difficult it is work with the existing formulation of glucagon because Lilly is the leading global seller of emergency glucagon kits. The kit comes in a red case with a syringe pre-filled with liquid and a vial of powdered glucagon. On its own website Lilly lays out the following steps on how to use this kit<\/a> to deliver glucagon to someone who is in hypoglycemic distress and cannot deliver it themselves:<\/p>\n

\u201c1. Flip the seal from the vial of Glucagon powder.<\/p>\n

    \n
  1. Remove the needle cover from the syringe. DO NOT REMOVE THE PLASTIC CLIP FROM THE SYRINGE, as this may allow the push rod to come out of the syringe.<\/li>\n
  2. Insert the needle into the rubber stopper on the vial, then inject the entire contents of the syringe into the vial of glucagon powder.\u201d<\/li>\n<\/ol>\n

    There then follows six more steps that include mixing the glucagon, injecting the glucagon, and then disposing of the one-use set up. All this, keep in mind, is being done while a person with diabetes may be suffering a severe hypoglycemic episode that could include seizures and\/or loss of consciousness.<\/p>\n

    It was this complexity, and a desire to protect his two sons who have diabetes, that prompted Oringer to work on developing a system\u2014any system\u2014better than the one that existed.<\/p>\n

    Before his two sons were born Oringer had made a living developing and selling products for people living with diabetes in the U.S. \u201cI was one of the first people to do private label lancets, syringes, glucose test strips, and other products initially for independent pharmacies, then regional and small pharmacy chains, and eventually large chains like Walgreens, CVS, and Walmart,\u201d he says. \u201cPeople referred to me as \u2018the private label diabetes guy\u2019 in the 90s.\u201d<\/p>\n

    Then, in the late 1990s his first son, aged three, and his second son, aged nine months, were both diagnosed with diabetes.<\/p>\n

    \u201cIt was ironic\u2014sadly ironic\u2014but, more than that, it put me on guard.\u201d<\/p>\n

    What he guarded against most was the need for reviving either of his sons if they suffered a severe hypoglycemic episode. Then, one day while discussing the problem of glucagon delivery with colleagues and a key advisor, Oringer and his team had what he calls an epiphany.<\/p>\n

    \u201cGlucagon is in powder form,\u201d he says. \u201cIt struck us that maybe it doesn\u2019t have to be mixed. After all, there are other drugs that people take in powder form that hit them directly, yes? And, if it doesn\u2019t have to be mixed, maybe it doesn\u2019t have to be injected.\u201d<\/p>\n

    In 2015 Lilly acquired the rights to Locemia\u2019s nasal glucagon.<\/p>\n

    In clinical trials results released in June Lilly said that 95.7% of patients who used the nasal glucagon responded with blood sugar levels close to normal within 30 minutes of taking the powdered glucagon.<\/p>\n

    The new formulation, which does not yet have a name, also does not require patients to inhale the powder, Guzman says. It\u2019s absorbed into the cells of the nasal mucosa.<\/p>\n

    \u201cI am really excited to be a part of this effort,\u201d Guzman says. \u201cAt Lilly we\u2019ve had a long history with diabetes. We made the first commercially available insulin. And this is just another step in our commitment to helping people with diabetes.\u201d<\/p>\n

    Oringer is likewise pleased that his idea has evolved to become something people can benefit from.<\/p>\n

    \u201cI hope everyone carries it,\u201d he says, \u201cand that no one ever has to use it.\u201d<\/p>\n

     <\/p>\n","protected":false},"excerpt":{"rendered":"

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