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@DrMakaryFDA One thing that I appreciate about you is that you love INNOVATION. You don’t like me too drugs that lack ingenuity.
The FDA at this moment, has an NDA from Aquestive Therapeutics that has a potential to change the world for the better for people with high risks of severe allergic reactions and anaphylaxis. For decades EpiPen has made it less painful than the manual IM but it’s still a needle. As you know, needle phobia is a real barrier for people. This is why approximately 85% of the 30 to 40 million people who have been diagnosed with having high risk of severe allergic reactions and anaphylaxis still don’t get epinephrine prescriptions! This has deadly consequences as you know.
Last year, the FDA approved Neffy, a first needle free epinephrine treatment in a nasal spray. Although this is a big improvement over the epinephrine auto injectors and addressed the needle phobia for many patients, Neffy, being a device with a carrying case still doesn’t address the biggest problem- the carry part. It’s a behavioral problem. Patients have to actively make a choice every day and through out the day as they live their lives. PEOPLE STILL FORGET. Again, this has tragic consequences.
The sponsor for the drug is Aquestive Therapeutics, and the drug is called Anaphylm, the first oral, non-device epinephrine treatment. This sir is a game changer. Why?
1. It works
2. It works quickly
3. It gets epinephrine to therapeutic levels in 5 minutes
4. It gets to peak concentration in 12 minutes
5. It passes all 11 clinical trials with outstanding safety and efficacy
6. Taking medication orally is the most instinctive and universally recognizable since the first medicine was invented
7. Being the size of a postage stamp and fitted in a flat sleeve, Anaphylm can be carried on the back of the phone. This is what is missing. People only need to put Anaphylm on the back of their phone once and it will be with them practically everywhere throughout the day, everyday. This is the biggest innovation ever besides the discovery of epinephrine itself!
8. Anaphylm turns an inconsistent active decision into a passive one if it’s stored on the back of the phone
9. Anaphylm is made up only 2% water. It’s more durable under extreme conditions such as heat or freezing.
10. Anaphylm is not a device. Even though rare but devices like Neffy and EpiPen can malfunction sometimes. Also the epinephrine in the device is liquid and is prone to over heating or freezing. Neffy has instructions on how to address the freezing issue in its PI!
Why am I so passionate about this? 33 years ago, I lost my sister. She had an anaphylactic shock in front of my family. It still feels like yesterday. The image doesn’t go away.
I am hoping that you would approve Anaphylm so it can begin to help people around the world.
Thank you for your service @DrMakaryFDA
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