Noctiva becomes first FDA approved treatment for nocturia syndrome
Serenity Pharmaceuticals’ nasal spray to treat the nocturnal polyuria syndrome in adults, Noctiva (desmopressin acetate) has secured the US FDA approval.
Nocturnal polyuria syndrome or simply nocturia syndrome is a condition where a person has to wake up more than twice during the night to urinate. Noctiva is now the first treatment for nocturnal urine overproduction that has been approved by the FDA.
Developed by Serenity Pharmaceuticals, Noctiva is marketed by Renaissance Lakewood.
Samuel Herschkowitz, the Chief Executive Officer of Serenity Pharmaceuticals on Noctiva FDA approval said: “Until now, there have been no treatment options specifically approved for those who struggle with nocturia due to nocturnal polyuria.
“Physicians now can have even greater confidence when offering their patients an approach to treating this problematic medical condition. We worked closely with the FDA and the medical community to develop this important new medication, and we look forward to bringing it to patients in the near future.”
The Noctivia nasal spray for the nocturnal polyuria treatment needs to be taken about 30 minutes prior to bedtime every night. Noctivia enhances the water absorption through the kidneys, thus resulting in lesser urine production to control the nocturnal polyuria syndrome.
Hylton V. Joffe, M.D., M.M.Sc., director of the Division of Bone, Reproductive, and Urologic Products in the FDA’s Center for Drug Evaluation and Research said: “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.
“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.”
As per the FDA, efficacy of the Noctiva nocturnal polyuria treatment was demonstrated in two randomized, placebo-controlled trials for a span of 12 weeks in 1,045 of 50 plus years of age having nocturia due to nocturnal polyuria syndrome.
The trials despite yielding only a minor reduction in the average number of urinations in the night with Noctiva against placebo, more patients with Noctiva treatment were able to bring down their night-time urinations by atleast half the number of urinations. Also patients who had Noctiva nocturnal polyuria treatment had registered more nights where they had one or lesser urinations in the night-time.
As per the FDA, there are other medications containing desmopressin which it had approved but none of them were approved for treating nocturnal polyuria.
Although there are other FDA-approved medications that also contain desmopressin, none of those medications are approved to treat nocturia.