Adamis developed a single-dose epinephrine pre-filled syringe to treat anaphylaxis.
The US Food and Drug Administration (FDA) has granted approval to Adamis for its epinephrine pre-filled syringe to treat Type 1 allergic reactions and anaphylaxis, creating a more affordable alternative to Mylan’s EpiPen.
The company made the announcement in a news release issued today.
The drug will be offered under the trade name of Symjepi. Packaging will contain two single-syringe doses of 0.3 mg.
Dennis J. Carlo, president and CEO of Adamis, heralded the announcement, adding that the company will soon submit a second new drug application (NDA) to the FDA for a "junior version."
"We are committed to helping patients by providing them with additional therapeutic choices," he said. "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 market."
Adamis had filed for resubmission of its NDA with the FDA on December 4, 2015 after addressing issues raised by the agency in a March 2015 complete response letter (CRL), according to a news release from the company. In the CRL, the FDA cited concerns about the syringe’s ability to deliver the does stipulated on the packaging. The FDA raised no other concerns at the time. Adamis redesigned the product accordingly and resubmitted its NDA, which was later accepted for review in January 2016.
Adamis has billed its epinephrine pre-filled syringe as a more affordable alternative to Mylan’s EpiPen. The device delivers a single dose of the drug to treat anaphylaxis associated with certain foods, insect stings and bites, drugs, as well as idiopathic or exercise-induced anaphylaxis.