Marketing authorization received for Lyfaquin(TM) (centhaquine) to treat patients with hypovolemic shock from 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.
Pharmazz, Inc. is a privately held company engaged in the development of novel products in the area of critical care medicine. Additional information may be found on the Company's website, www.pharmazz.com.
This press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties including the risk that Pharmazz, Inc. cannot execute its business plan for lack of capital or other resources, distribution, partnering or licensing/acquisition opportunities. Actual events or results may differ materially from those projected in any of such statements due to various factors. Any of these risks could cause Pharmazz, Inc. or its industry's, actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by the forward-looking statements in this presentation. Except as required by applicable law Pharmazz, Inc. does not intend to update any of the forward-looking statements to conform these statements to actual results.
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SOURCE Pharmazz, Inc.
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