FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

NICE Backs Bladder Pain Drug Elmiron

Oct. 23, 2019
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The UK’s National Institute for Health and Care Excellence (NICE) is recommending Consilient Health’s Elmiron (polysulfate sodium) for treatment of bladder pain syndrome despite some reservations about the supporting data.

The agency noted that the available evidence for the drug’s benefits is “not of high quality” but that the most plausible cost-effectiveness estimates for the drug compared with bladder instillations are likely to make it a cost-effective use of NHS resources.

Clinical trials suggest that the drug may be more effective at relieving pain than placebo and there may be a modest benefit over other forms of care, but it’s unclear how much benefit it provides because the treatments have not been directly compared, the agency said.

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