FDA approves EpiPen rival

FDA approved epinephrine injection (Symjepi, Adamis Pharmaceuticals), a cheaper alternative to Mylan’s EpiPen,

Mylan made headlines last summer for reportedly repeatedly raising the price of its life-saving medication. It increased the price of a pair of EpiPens from $94 in 2007 to $608 last year. After receiving backlash due to the price hike, Mylan launched generic EpiPens last December.

Symjepi is indicated in the emergency treatment of allergic reactions to stinging and biting insects, allergen immunotherapy, foods, drugs, diagnostic testing substances, and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.

Currently, brand EpiPens cost about $630 to $700 without insurance while the new generic version retails for about $225 to $425. It is estimated that is costs less than $20 to produce a pair of EpiPens.

According to Adamis, Symjepi is intended to be a low-cost alternative to EpiPen and similar products, and the company is aiming to sell it for less than generic EpiPens. The manufacturer said that Symjepi is easier to use than EpiPen and is also smaller than EpiPen so it is easier to fit in a pocket or purse.

Higashi

"For better or worse, whether you look at things half full or half empty we have a capitalistic society," said Stephanie Higashi, DC, chief executive of the integrated healthcare practice HEALTH ATLAST. "An open marketplace with competition and a society that thrives, drives on 'opportunity'-the American Dream getting and being rich. There are balance sheets, shareholders, profit margins, overhead and many people working to find a way to make more money and profit. What does this have to do with an Epipen? Well, Symjepi will likely be a lower cost option that’s more attainable. I am certain even a billionaire with a heart wouldn't want to see a person gasping for their last breath of air because they couldn't afford a $608 epi-pen when the cost to produce it to save the person's life is a mere $20."

Symjepi will be available as a single-dose, pre-filled syringe for manual injection containing 0.3 mg/0.3 mL epinephrine sterile solution for injection. Patients greater than or equal to 30 kilograms (66 pounds) are to inject Symjepi intramuscularly or subcutanteously into the anterolateral aspect of the thigh, through clothing if necessary.

Like EpiPen, Symjepi is expected to be sold in pairs, which makes it more convenient for children and adults with severe food or insect allergies that carry a device on the go and leave a spare at home, school or work. Additionally, Adamis is preparing to apply for FDA approval of a “junior version” of Symjepi, that would contain a lower epinephrine dose and would compete with Mylan’s EpiPen Jr.

Symjepi is indicated in the emergency treatment of allergic reactions to stinging and biting insects, allergen immunotherapy, foods, drugs, diagnostic testing substances, and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.

Adverse reactions to all epinephrine products include anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitation, nausea and vomiting, headache, and/or respiratory difficulties.

Adamis is still lining up a distributor so the price of the medication is not currently known but Symjepi is expected to go on sale later this year.