Washington: For the first time, the US Food and Drug Administration (FDA) has approved a treatment for adults who awaken at least two times per night to urinate.
FDA said it has approved Noctiva nasal spray only for adults with nocturia caused by nocturnal polyuria -- overproduction of urine during the night.
"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," Hylton V. Joffe from FDA's Center for Drug Evaluation and Research said in a statement on Friday.
"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," Joffe added.
Nocturia (waking at night to urinate) is a symptom that can be caused by a wide variety of conditions, such as congestive heart failure, poorly controlled diabetes mellitus, medications, or diseases of the bladder or prostate.
Noctiva is taken daily, approximately 30 minutes before going to bed.
It works by increasing the absorption of water through the kidneys, which leads to less urine production.
Noctiva's efficacy was established in two 12-week, randomised, placebo-controlled trials on 1,045 patients 50 years of age and older with nocturia due to nocturnal polyuria.
Although these trials showed a small reduction in the average number of night-time urinations with Noctiva compared to placebo, more patients treated with Noctiva were able to at least halve their number of night-time urinations, and patients treated with Noctiva had more nights with one or fewer night-time urinations.
The most common side effects of Noctiva in clinical trials included nasal discomfort, cold symptoms (nasopharyngitis), nasal congestion, sneezing, high or increased blood pressure, back pain, nose bleeds, bronchitis and dizziness.
Noctiva is marketed by Milford, Pennsylvania-based Renaissance Lakewood, LLC for Serenity Pharmaceuticals, LLC.