FDA advisory committee approves of Allergan’s night-time urination medicine

pharmafile | October 20, 2016 | News story | Medical Communications Allergan, FDA, Night-time urination, sleep, urination 

The FDA’s advisory committee ruled, in a 14-4 vote, that Allergan’s experimental nocturnal urination medication, SER120, in favour of the benefit risk profile. The naysayers within the vote were not duly impressed by the efficacy of the product but the majority carried.

The medication is designed to treat those who experience frequent urination in the evening, which is applicable to those who visit the bathroom twice or more – though there is a caveat that this is based on the total urine volume, to avoid general prescription of the drug. This means that the drug will only be prescribed to those with polyuria, where there is an increase in urination in the night-time and a drop off in the daytime. Allergan is looking to gain approval to market the drug for more general frequent nightly urination cases.

SER120 is a low-dose nasal version of desmopressin, which is a drug used to treat conditions including diabetes insipidus.

Regarding their recommendation of the drug, the FDA committee commented that: “Millions of these patients have two or more nocturic episodes per night, interrupting sleep, increasing the risk of falls and other traumatic injuries as well as impairing daytime functioning and overall health”.

The medication was purchased from Serenity Pharmaceuticals in 2010, for a price of $165 million.

Ben Hargreaves

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