As allergy sufferers reel from the soaring costs of the EpiPen — a handheld auto-injection device of epinephrine made by Mylan that prevents life-threatening anaphylactic shock — a new oral tablet alternative is being tested that could solve a host of issues.
This comes at a time when the price of the injector has skyrocketed 500 percent since 2007. It now costs $500. That's an expensive dilemma for approximately 43 million people suffering from life-threatening allergies in the United States. Many find the price tag prohibitively expensive.
According to Popular Science, a researcher at Nova Southeastern University in Florida is responding to both the consumer outrage over the EpiPen price hike as well as to Mylan's monopoly on the device. Rather than create a new epinephrine injector, pharmaceutical researcher Mutasem Rawas-Qalaji has been exploring the development of an Epi-Pill, an epinephrine tablet that dissolves under the tongue.
Such an orally disintegrating tablet (ODT) is good for people who have trouble swallowing. It is also a way to deliver medicine orally without getting the digestive tract involved, so the drug can quickly flow into the bloodstream in seconds.
Such a pill would bypass the patent issues that allow Mylan to corner the market on the epinephrine injector, but there is a host of other issues standing in the way.
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.
"I imagine it may be difficult to persuade parents to switch from the tried-and-tested EpiPen to a new and radically different method of drug delivery," said Matthew Allen, head of drug delivery at Cambridge Consultants, a product development and design firm. Additionally, he said that even if it's successfully tested and brought to market, don't expect Mylan to take the competition lying down.
"All pharma companies work hard for their shareholders to maximize their returns, and the manufacturers of EpiPen will use their marketing expertise to protect or enhance their position," he said. "Anyone launching a new product has to deal with that marketing competition, and this would be no different."
Allen also added that while a pill wouldn't necessarily compete with the EpiPen, it would still have to stand on its own merits and demonstrate its reliability to consumers — a tall order.
"At the moment, the biggest barriers are … successfully marketing against a market leader and, probably most challenging, convincing users that the product is as safe and reliable as EpiPen," Allen said.
And what does Rawas-Qalaji himself have to say about the challenges inherent in bringing the Epi-Pill to market? In many ways, he faces the same hurdles that any other inventor faces when introducing a new idea to the public: "Raising enough money by investors to support the product development, and a wise marketing strategy," he told CNBC.
He added, "We have overcome the technical risks and now are facing commercial risks associated with FDA approvals, legal protection and bringing a revolutionary pharmaceutical product to the general public."
Human testing remains the largest barrier to developing the product. After all, inducing anaphylaxis in human subjects and hoping an untested invention will pull them back from the brink of death is unethical, to put it mildly.
Rawas-Qalaji described this type of human testing as unacceptable. Rather, he said he plans to test the Epi-Pill by comparing the epinephrine plasma concentrations of an already established product to those of his formulation. Conducting this test in healthy volunteers would be the next step in the long process that he was inspired to embark upon six years ago.
"My inspiration was a serious unmet medical need, due to children in danger, mothers afraid to treat their children, too many serious allergenic reactions and the rising costs of commonly used methods," he said. "I hope the development of this product is successful and can be registered as early as possible, to meet the needs of the patients and reduce the level of anxiety associated with the self-administration of epinephrine injections."
— By Daniel Bukszpan, special to CNBC.com