Right now consumers and medical professionals point to EpiPen flaws. Most notably, a study published last year showed only 16 percent of patients used the device correctly. Plus, the devices expire after a year and are bulky and hard to carry around.

In contrast, if it worked, the Epi-Pill would have a shelf life of up to seven years.

The challenge now is testing to see how the pill would work in people actually experiencing anaphylaxis.

"Due to the uniqueness and variability of severity of these life-threatening allergic reactions, it's unethical to conduct trials on patients experiencing anaphylaxis or induce anaphylactic reactions to conduct a study for EpiPill or any other alternative injectable or non-injectable dosage form," Rawas-Qalaji told CNBC.

Although he did not disclose the nature of the trials that would one day be conducted, he said that "the testing will be conducted in a manner that meets the FDA regulations and requirements and expectations for registration."



A big unknown is how the swollen mouth of a patient in anaphylactic shock might absorb epinephrine versus a person with a healthy mouth.

Rawas-Qalaji has already met with the FDA and filed for a Pre-Investigational New Drug meeting. In the first meeting, the agency discussed its expectations for Epi-Pill registration, the design of Rawas-Qalaji's planned studies and any additional studies that may be necessary afterward.

So far, no date has been set to begin clinical trials, but Rawas-Qalaji told CNBC that the required work preceding the clinical trials has already begun and is well under way.

As for the price, Rawas-Qalaji feels the pills can be manufactured and sold at an affordable price.



He hopes to get FDA approval before Mylan's patents are up in 2025, although he said it's possible the product will be on store shelves for consumers before then.

Rawas-Qalaji said that medications administered through the nasal or oral mucosa are absorbed quickly, so those routes of administration might create the opportunity for an invention to compete against the EpiPen. But apart from the medical challenges an Epi-Pill would face, there would also be challenges in introducing it to the market.