FDA approves Serenity Pharmaceuticals’ Noctiva for nocturnal polyuria

Serenity Pharmaceuticals has received U.S. Food and Drug Administration (FDA) approval for Noctiva (desmopressin acetate), a nasal spray developed to treat nocturnal polyuria syndrome in adults. This marks a significant milestone as Noctiva becomes the first FDA-approved treatment specifically for nocturnal urine overproduction, commonly known as nocturia syndrome.

Groundbreaking Treatment for Nocturnal Polyuria

Nocturnal polyuria syndrome, which compels individuals to awaken more than twice during the night to urinate, now has a promising solution in Noctiva. The nasal spray, to be marketed by Renaissance Lakewood, is designed to be administered about 30 minutes before bedtime, enhancing water absorption through the kidneys and thus reducing urine production overnight.

Samuel Herschkowitz, CEO of Serenity Pharmaceuticals, expressed his enthusiasm about the FDA approval: “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.”

FDA’s Endorsement and Clinical Trials

The efficacy of Noctiva was demonstrated in two randomized, placebo-controlled trials spanning 12 weeks and involving 1,045 patients aged 50 and older who suffer from nocturia due to nocturnal polyuria. While the trials showed only a minor reduction in the average number of nighttime urinations compared to placebo, a significant number of patients treated with Noctiva experienced a reduction of at least half in their nighttime urinations. Furthermore, these patients reported more nights with one or no urinations, indicating a substantial improvement in quality of life.

Hylton V. Joffe, M.D., M.M.Sc., director of the Division of Bone, Reproductive, and Urologic Products at the FDA’s Center for Drug Evaluation and Research, highlighted the importance of the approval: “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.”

The approval of Noctiva by the FDA is a pivotal development in the management of nocturnal polyuria. It not only provides a targeted treatment option but also broadens the understanding and potential therapeutic strategies for a condition that affects a significant portion of the adult population, especially older adults.

As nocturia syndrome has often been overlooked in medical discussions, the introduction of Noctiva could lead to greater awareness and more effective management of the condition, ultimately enhancing patient outcomes and quality of life.