Espero announced that the Food and Drug Administration (FDA) has approved GoNitro (nitroglycerin) sublingual powder for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.
This is the first approved short-acting nitrate formulated as stabilized crystal granules. Each packet of GoNitro contains 400mcg of nitroglycerin. Clinical data showed the sublingual route has higher absorption compared to Nitrolingual Pump Spray (nitroglycerin lingual spray).
Nitroglycerin is a vasodilator that forms free radical nitric oxide, which activates guanylate cyclase, resulting in an increase of guanosine 3′, 5′-monophosphate (cyclic GMP) in smooth muscle and other tissues. This eventually leads to dephosphorylation of myosin light chains, which regulates the contractile state in smooth muscle and results in vasodilation.
GoNitro will be supplied in cartons containing 36 single-dose packets. It is anticipated to launch in the second half of 2016. The product will be marketed under a licensing agreement with Pohl Boskamp.
For more information call (800) 235-6520 or visit EsperoPharma.com.