The FDA announced approval of Noctiva (desmopressin acetate).
The FDA announced approval of Noctiva (desmopressin acetate). The nasal spray is indicated to treat adults who experience nocturia due to a condition known as nocturnal polyuria, which causes the overproduction of urine during the night.
Noctiva, which is marketed by Renaissance Lakewood, LLC for Serenity Pharmaceuticals, LLC, is for individuals who awaken at least 2 times per night to urinate due to nocturia. It is taken daily, approximately 30 minutes before going to bed, and helps increase the absorption of water through the kidneys to decrease urine production.
The FDA approval is based on Noctiva’s efficacy, which was established in 2, 12-week clinical trials including participants with nocturia due to nocturnal polyuria. The results showed a small reduction in the average number of time-time urinations. More participants treated with Noctiva experienced at least half the amount of night-time urinations and had more nights with 1 or fewer night-time urinations.
Noctiva is approved with a boxed warning and a medication guide due to its potential to cause low sodium levels in the blood (hyponatremia), which can be life-threatening if not promptly diagnosed and treated. Health care providers should check patients’ sodium levels before starting Noctiva and monitor levels throughout treatment.
Patients with symptomatic congestive heart failure, uncontrolled hypertension, and certain nasal conditions should not use Noctiva. Common adverse effects associated with the drug include nasal discomfort, cold symptoms, nasal congestion, sneezing, high or increased blood pressure, back pain, nosebleeds, bronchitis, and dizziness.
FDA approves first treatment for frequent urination at night due to overproduction of urine [news release]. FDA’s website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm544877.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed March 3, 2017.