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NEW BRANDED VERSION OF TORSEMIDE MAKES VAGUE CLAIMS AND OFFERS NO EVIDENCE
soaanz

March 23, 2022 - The FDA recently approved a new branded version of torsemide called Soaanz from Sarfez Pharmaceuticals. Torsemide is a loop diuretic that has been available since 1993. The original version of torsemide was marketed under the name Demadex, but it has been discontinued, and now only generic versions of the drug are available. Soaanz was approved as a reference listed drug, which means it is not considered bioequivalent to generic versions of torsemide.

So what is unique about Soaanz? The manufacturer's website says that it is "Specially formulated" and has "slow drug release" so that it "may reduce excessive urination" and "may help with incidences of hypokalemia" [Soaanz website] But the Soaanz prescribing information (PI) makes no mention of any type of delayed- slow- or extended-release formulation. Under the pharmacokinetic information, it states that peak plasma concentrations occur within 2.5 hours, while the torsemide PI states that serum concentrations peak within 1 hour. Since 1 hour is within 2.5 hours, it's unclear how the absorption of Soaanz differs. The Soaanz PI also states that "the onset of diuresis occurs within 1 hour and the peak effect occurs during the first four hours and diuresis lasts about 6 to 8 hours," while the torsemide PI says, "the onset of diuresis occurs within 1 hour and the peak effect occurs during the first or second hour and diuresis lasts about 6 to 8 hours." Again, besides semantics, what exactly is the difference here?

As far as the claims that Soaanz "may reduce excessive urination" and "may help with incidences of hypokalemia," it's unclear if the manufacturer is drawing a comparison to other loop diuretics or generic torsemide. The only mention of a Soaanz-specific study in the PI is under adverse events, where it states the following, "In pre-approval studies, Soaanz has been evaluated for safety in 65 subjects. Discontinuation of therapy due to adverse reactions occurred in 4 out of the 65 of subjects (6%) treated with Soaanz." [Soaanz PI]

One difference Soaanz definitely has with torsemide is the cost. GoodRx shows that the current cash-pay price for thirty Soaanz 20 mg tablets is around $250, compared to $6 for generic torsemide. In an interview, the CEO of Sarfez Pharmaceuticals, Salim Shah, stated that "The company has benefited from grants from the Small Business Administration and the National Institute of Health to develop Soaanz." He goes on to say that he was aiming to price the drug around $35 a month because "We're going to price this drug based on our patients' affordability, not how much we can get from insurance companies or what the market dictates." [Soaanz article]

We reached out to the manufacturer to see if they could direct us to any studies involving Soaanz but have not yet received a response. Apparently, taxpayer dollars were used to develop the drug, so it begs the question, what did we get for our money besides an overpriced version of torsemide?

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