Chest Pain Treatment GoNitro Under FDA Review
The FDA has accepted Espero Pharmaceuticals' new drug application for GoNitro, a product designed to treat an attack or prophylaxis of angina pectoris due to coronary artery disease.
The FDA has accepted Espero Pharmaceuticals’ new drug application (NDA) for GoNitro, a product designed to treat an attack or prophylaxis of angina pectoris due to coronary artery disease.
The nitroglycerin powder is for sublingual use and would ideally provide acute relief of chest pain.
GoNitro was originally developed by Pohl-Boskamp, a German pharmaceutical company. However, Espero has a licensing and distribution agreement with Pohl-Boskamp in the US market. The German pharmaceutical company is supporting the submission of Espero’s NDA.
“The FDA’s acceptance for review of this application for nitroglycerin powder for sublingual use represents a key milestone in advancing treatment options and benefits to individuals with this critical cardiovascular condition,” said Quang Pham, CEO of Espero Pharmaceuticals, in a press release. “This novel presentation represents the first product innovation in this category in nearly 20 years.”
The FDA will complete its review of GoNitro by June 10, 2016.