GONITRO™ to Participate in First-of-its-Kind Comparative Effectiveness ISCHEMIA Clinical Trial Sponsored by the National Institutes of Health
JACKSONVILLE, Fla. (Jan. 19, 2017) – Espero Pharmaceuticals, Inc., a commercial-stage cardiovascular pharmaceutical company, will donate GONITRO™ (nitroglycerin sublingual powder) to the ongoing International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) clinical trial and to the ISCHEMIA-Chronic Kidney Disease (CKD) ancillary trial. The company’s executives provided an update during last week’s annual JP Morgan Healthcare Conference in San Francisco, California.
The ISCHEMIA Trial is a randomized controlled trial studying 8,000 patients with stable ischemic heart disease (SIHD) and moderate to severe ischemia. The study is funded by the National Heart, Lung, and Blood Institute (NHLBI), a part of the National Institutes of Health (NIH) of the U.S. Department of Health and Human Services. It has 336 enrolling sites in 35 countries worldwide, with 126 sites in the US.
The primary aim of the ISCHEMIA trial is to determine whether an initial invasive strategy of cardiac catheterization followed by stent or bypass surgery, if appropriate, plus optimal medical therapy will reduce cardiovascular death or nonfatal myocardial infarction as compared with a conservative strategy of initial optimal medical therapy, with cardiac catheterization reserved for those who fail medical therapy. An additional 500-700 patients with advanced chronic kidney disease (eGFR <30 or dialysis) are being randomized in the NHLBI-funded ISCHEMIA-CKD ancillary trial.
“We are excited GONITRO™ has been selected to participate in the landmark ISCHEMIA Trial to determine the optimal way to manage SIHD,” said Quang Pham, Chief Executive Officer of Espero Pharmaceuticals. “The current practice guidelines state that all patients suffering from SIHD should be prescribed a short-acting nitrate for angina.”
“We are appreciative of the donation made by Espero Pharmaceuticals,” commented Judith S. Hochman, MD, Chair of the ISCHEMIA Trial, the Harold Snyder Family Professor of Cardiology, associate director of the Leon H. Charney Division of Cardiology, and Senior Associate Dean for Clinical Sciences at NYU Langone Medical Center. “Short-acting nitrates are important to our patients and trial,” said David Maron, MD, the trial’s Co-Chair and Principal Investigator.
GONITRO™ is a recently approved short-acting nitrate in a patented, stabilized crystal granule form available in single dose packets for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. Each individual packet of GONITROTM contains 400 mcg of nitroglycerin. Additional information about GONITRO™ can be found at www.gonitrorx.com.
About Espero Pharmaceuticals
Espero Pharmaceuticals, Inc., www.esperopharma.com, is a commercial-stage cardiovascular pharmaceutical company engaged in maximizing the commercial value of proven treatments that improve the quality of life for patients. Espero is focused on compounds with proven safety and efficacy administered via novel delivery solutions in the cardiovascular and other specialty therapeutic categories. Through Jacksonville Pharmaceuticals, its wholly owned subsidiary, the company markets and distributes selected generic pharmaceutical products including the authorized generic version of Nitrolingual® Pumpspray (nitroglycerin lingual spray).