Pharmazz, Inc., a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat patients in critical care, today announced that it has received marketing authorization of centhaquine, a first-in-class drug, to manage patients with hypovolemic shock from the Indian regulatory agency.
| WILLOWBROOK, Ill., May 14, 2020 /PRNewswire/ -- Pharmazz, Inc., a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat patients in critical care, today announced that it has received marketing authorization of centhaquine, a first-in-class drug, to manage patients with hypovolemic shock from the Indian regulatory agency. Centhaquine is likely to be a transformational therapy for hypovolemic shock because it ameliorates key drivers of mortality. Hypovolemic shock is triggered by severe fluid loss, which is most commonly driven by hemorrhages (trauma, GI bleeding, post-partum hemorrhage, etc.), or fluid loss from vomiting or diarrhea – the result is decreased cardiac output, poor blood circulation, and organ failure. Severe hypovolemic shock has high mortality and there is a significant need for novel therapies. Hypovolemic shock may be an attractive white space opportunity due to its high incidence and limited pipeline competition. Centhaquine is likely to be a front-line therapy, and used in conjunction with standard of care, and is well positioned to address key unmet need in hypovolemic shock. It ameliorates hypovolemic shock by redistributing blood, thereby preserving organ function and ameliorating mortality. Centhaquine’s pivotal phase III study in India in hypovolemic shock demonstrated a transformational improvement over standard of care in increasing blood pressure and reducing blood lactate levels, both of which are key measures of improving blood flow and increasing blood perfusion of organs. It significantly reduced mortality in its trials. Centhaquine is well tolerated (in phase II and III studies), no serious adverse events were attributed to centhaquine. It uniquely does not act on beta adrenergic receptors, thereby avoiding significant toxicities (e.g. myocardial dysfunction). Pharmazz will be working with the regulatory agency in India to get the approval of carton, label, package insert, IPC testing, update stability, and submit post-marketing trial protocol and launch centhaquine under the brand name of Lyfaquin™. About Pharmazz, Inc. Forward-Looking Statements Contact
SOURCE Pharmazz, Inc. |
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