MORRISVILLE, N.C.--(BUSINESS WIRE)--Tenax Therapeutics, Inc. (NASDAQ: TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products for the critical care market, today provides a regulatory update following discussions with the U.S. Food and Drug Administration (FDA) and Health Canada regarding a regulatory path forward for levosimendan.
In May 2017, the Company participated in a pre-NDA meeting with the FDA to discuss the possibility of submitting an NDA for levosimendan in two indications: treatment of patients undergoing coronary artery bypass grafting (CABG) to reduce the risk of low cardiac output syndrome (LCOS) and treatment of patients with acute decompensated heart failure (ADHF) for improvement in symptoms. After a review of further analyses, the FDA has requested an additional clinical trial. Given the size and scope of such a trial, the Company is reviewing clinical, regulatory and financial options with regard to the levosimendan program in the U.S. and Canada.
The Company’s Board of Directors is continuing its review of strategic alternatives with the assistance of their financial advisors at Ladenburg Thalmann & Co. Inc. Strategic alternatives under review include, but are not limited to a merger, a business combination, a strategic investment into the Company, or a purchase, license or other acquisition of assets. This process may not result in any transaction and the Company does not intend to disclose additional details unless and until it has entered into a specific transaction.
Levosimendan is a calcium sensitizer that works through a unique triple mechanism of action. It initially was developed for intravenous use in hospitalized patients with acutely decompensated heart failure. It was discovered and developed by Orion Pharma, Orion Corporation of Espoo Finland, and is currently approved in over 60 countries for this indication and not available in the United States. Tenax Therapeutics acquired the North American rights to develop and commercialize levosimendan from Phyxius Pharma.
About Tenax Therapeutics
Tenax Therapeutics, Inc., is a specialty pharmaceutical company focused on identifying, developing and commercializing products for the critical care market. For more information, visit www.tenaxthera.com.