FDA approves first treatment for excessive night-time urination
pharmafile | March 6, 2017 | News story | Manufacturing and Production | FDA, Noctiva, Serenity
The FDA has approved Noctiva, administered as a nasal spray, for the treatment of people suffering from nocturnal polyuria – going to the toilet too many times, in layman terms. The treatment is the first such treatment approved for the purpose after displaying sufficient efficacy in two 12 week trials.
The treatment was developed by Serenity Pharmaceuticals and is meant for nightly use in those that need to visit the toilet two or more times at night. The condition can lead to loss of sleep, as sufferers’ sleep is disturbed by needing to visit the bathroom, and potentially more serious side-effects, such as falls that result in broken bones or worse, as the sufferers stumble to the toilet in a drowsy state.
The approval was based upon the two clinical trials made up of 1,045 patients aged 50 years and older. The studies found that those taking the medication were more likely to show night-time urinations halves in number – with more nights with one or zero urinations, compared to placebo.
The potential risks of taking the medication are a decrease in sodium levels in the blood (hyponatremia); the action of the drug causes an increased uptake of water through the kidneys. This means that the medication has to have a warning on the box for those who may be at risk hyponatremia or those who have kidney damage.
“Today’s approval provides adults who overproduce urine at night with the first FDA-approved therapeutic option to help reduce the number of times a night they wake up to urinate,” said Hylton V. Joffe, Director of the Division of Bone, Reproductive, and Urologic Products in the FDA’s Center for Drug Evaluation and Research. “It is important to know that Noctiva is not approved for all causes of night-time urination, so patients should discuss their symptoms with their health care provider who can determine the underlying cause of the night-time urination and whether Noctiva is right for them.”
Ben Hargreaves
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