FDA Approves New Chest Pain Treatment

The FDA has approved Espero Pharmaceuticals Inc’s nitroglycerin sublingual powder (GoNitro) for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.

GoNitro comes in single-dose packets and is the only FDA-approved short-acting nitrate in a stabilized crystal granule form.

“The FDA’s approval of GoNitro enhances the treatment options available to the more than 8 million US patients suffering with stable angina due to coronary artery disease, the most common type of heart disease,” said Quang Pham, founder and CEO of Espero Pharmaceuticals, in a press release.

Every package of GoNitro contains 400 mcg of nitroglycerin. In a clinical trial, GoNitro improved the sublingual absorption rate of nitroglycerin compared with the Nitrolingual Pumpspray. The spray, also marketed by Espero, has been on the market since 1997.

“Short-acting nitrates are the current standard of care for acute relief of an angina attack,” said A. Allen Seals, fellow of the American College of Cardiology, in a press release. “The novel features of a sublingual powder in a portable single dose packet make GoNitro attractive to angina patients who need fast relief and want to continue to live an active lifestyle.”

The most common side effects associated with GoNitro are headache, dizziness and paresthesia. Nausea, vomiting and weakness have also been observed in some patients. The drug is not recommended for patients who are taking PDE-5 inhibitors, such as sildenafil or avanafil. GoNitro should be available in the second half of 2016.