FDA Approves EpiPen Competitor

Adamis Pharmaceuticals Corporation recently announced the FDA has approved the company’s epinephrine injection, USP 1:1000 (Symjepi), for the treatment of allergic reactions, including anaphylaxis, according to a press release.

The newly-approved epinephrine injection includes 2 single doses of the drug. Epinephrine is the gold standard of emergency anaphylactic reactions and can treat reactions to insect stings/bites, food, drugs, other allergens, and idiopathic or exercise-induced anaphylaxis, according to Adamis.

The epinephrine injector will be sold in a 2-pack, similar to its well-known competitor, EpiPen.

Recently, the increasing cost of the EpiPen has faced greater scrutiny, as the list price has grown more than 500% in 10 years to $600 for a 2-pack. Although the list price is not the price patients pay, Mylan launched an authorized generic version at half the cost to ease concerns.

The newly-approved epinephrine injection may be able to improve access to treatment for patients with allergies through lower pricing, according to the release.

“We are very excited by this approval, and at the same time, are already preparing to submit our second NDA to the FDA. This second submission is for the junior version of Symjepi. We are committed to helping patients by providing them with additional therapeutic choices,” said Dr. Dennis J. Carlo, PhD, president and CEO of Adamis. “With an anticipated lower cost, small size and user-friendly design, we believe Symjepi could be an attractive option for a significant portion of both the retail (patient) and non-retail (professional) sectors of the epinephrine market.”

In 2015, Adamis submitted a new drug application for the epinephrine injection to the FDA, but the company received a complete response letter (CRL) over concerns that the product may not be able to deliver a dosage compliant with the FDA and product labeling. They addressed the issues and resubmitted the application the same yet, according to a press release.

However, after the acceptance of the resubmission, the FDA issued another CRL in 2016 requesting additional human factors and reliability studies. Due to the results from the human factors study, Adamis believes that individuals would prefer their product over the EpiPen, according to the release. In December 2016, Adamis resubmitted the application and it was accepted in 2017.

Despite CRLs, the epinephrine injection was found to successfully reverse allergic reactions and it complied with FDA requirements, which lead to the approval.

Based on industry data, Adamis estimates that epinephrine sales in 2016 were more than $1 billion due to the growing understanding of the risk related to anaphylaxis and allergic reactions, according to the release.

“We are currently in the process of exploring all of our commercialization options and in discussions with potential partners in order to facilitate broad patient access to this new epinephrine treatment option and to maximize the value of our important asset,” Dr Carlo said. “In the interim, we expect to build inventory levels in preparation for an anticipated launch in the second half of this year.”