Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.US-based Adamis Pharmaceuticals has submitted a New Drug Application (NDA) to the US Food and Drug Administration for its epinephrine pre-filled single dose syringe (PFS) product.
Subscribe to our email newsletter
The EPINEPHRINE INJECTION, USP, 1:1000 (0.3mg Pre-filled single dose syringe) is designed for the emergency treatment of allergic reactions (Type I) including anaphylaxis.
The company’s PFS provides a single dose of epinephrine (adrenaline), which is considered the drug of choice for immediate administration in acute anaphylactic reactions to insect stings or bites, allergic reaction to foods, drugs and other allergens, as well as idiopathic or exercised-induced anaphylaxis.
The product is designed to be the low-cost, easy-to-use therapeutic alternative compared to the existing epinephrine auto-injectors.
Adamis president and CEO Dennis Carlo said the epinephrine market is large and growing and the company expects that auto-injector sales in the US in 2014 to approach one billion dollars.
"I believe our PFS could be an affordable substitute for the costly auto-injectors. These types of markets have proven to be cost sensitive and we expect epinephrine to be no different," Carlo said.
"Our PFS could allow Adamis to generate significant revenues and in time lead to profitability."
According to information published by industry sources, up to 8% of US children under the age of 18 have a food allergy, and about 38% of those with a food allergy have a history of severe reactions.
The company said that anaphylaxis requires immediate medical treatment, including an injection of epinephrine.
Image: Adamis’ epinephrine pre-filled single dose syringe is designed to be the low-cost, easy-to-use therapeutic alternative compared to the existing epinephrine auto-injectors. Photo: courtesy of Grant Cochrane/ freedigitalphotos.net