FDA to Review Sarfez Pharmaceuticals' Long-Acting Loop Diuretic 'SOANZXR': An Improved Treatment for Edema in Patients with Heart Failure, Kidney Disease and Hypertension
VIENNA, Va., July 9, 2019 /PRNewswire-PRWeb/ -- The U.S. Food and Drug Administration (FDA) has accepted Virginia-based company Sarfez Pharmaceuticals' New Drug Application for SoanzXRTM, a once-a-day extended release formulation of torsemide. If approved, SoanzXRTM will be the first and only long acting loop diuretic (water pill) that delivers the drug at a slower rate and provides drug effects for the majority of the day with a single dose. SoanzXRTM is expected to provide a new treatment option and benefits for heart failure patients by effectively reducing volume overload (e.g. edema) and blood pressure.
In addition to treating patients suffering from heart failure, SoanzXRTM also offers improved treatment options for patients with chronic kidney disease, liver cirrhosis with ascites, and hypertension. Loop diuretics are the drugs of choice for the treatment of volume overload caused by heart failure and chronic kidney disease. SoanzXRTM is an oral extended-release tablet with significantly longer duration of action compared to other marketed immediate release loop diuretics. SoanzXRTM coverage extends for most of the day and induces gradual and sustained urination thereby improving the quality of life for patients.
"SoanzXR will be the first long-release drug to treat heart failure, chronic kidney disease, and hypertension patients, greatly improving quality of life and hopefully reducing hospitalization time for chronic congestive heart failure patients," said Salim Shah, PhD, JD, Founder and Chairman, Sarfez Pharmaceuticals. "We look forward to supporting the FDA throughout SoanzXR's review process and once approved, providing improved treatment options for our patients."
The target FDA action date under the Prescription Drug User Fee Act (PDUFA) is anticipated to be before January 14, 2020. Once approved, Sarfez Pharmaceuticals is committed to providing SoanzXRTM at a reasonable price.
"The company has benefited from small business grants from the National Institute of Health to develop SoanzXR," said Shah. "We will transfer these benefits to patients by selling the drug at reasonable prices."
About Sarfez
Sarfez Pharmaceuticals, headquartered in Vienna, VA is a pharmaceutical research and development company focused on improving existing drugs to provide better treatment options for cardio-renal diseases. Sarfez Pharmaceuticals is dedicated to creating better treatment options and reducing patient expenses by improving existing cardiovascular drugs and offering them at a reasonable cost and with greater price transparency.
About SoanzXRTM
SoanzXR is developed to treat edema in patients with heart failure and kidney disease; as well as ascites in patients with liver disease, and hypertension. Clinical studies have shown that SoanzXR provides longer duration of action over the immediate release loop diuretics currently available on the market. Since SoanzXR releases drug at a slower rate and over a longer duration, and it induces gradual and sustained urination, it may help in reducing urinary incontinence, especially in older women.
Forward-looking Statement
Some statements such as FDA review and prospective approval are forward-looking. For these statements, we claim we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual statements to differ materially are the following: while we continue to work with the FDA, there is no assurance that we will answer all the questions to the FDA's satisfaction, that the FDA will ultimately approve the NDA by the expected date. Any forward-looking statements contained in this press release speak only as of the date hereof, and Sarfez expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
SOURCE Sarfez Pharmaceuticals Inc
