US regulators have issued a green light for the first treatment for frequent urination at night due to overproduction of urine, a condition known as nocturnal polyuria.
The US Food and Drug Administration has approved Allergan’s Noctiva (desmopressin acetate) nasal spray for adults who awaken at least two times per night to urinate.
The decision follows advice from the US Food and Drug Administration’s Bone, Reproductive and Urologic Drugs Advisory Committee, which voted 14-4 in favour of approving the therapy for nocturia back in October last year.
However, the drug’s use has been restricted to adults with nocturia caused by nocturnal polyuria, and so health care providers should confirm overproduction of urine at night with a 24-hour urine collection, if one has not been obtained previously, the regulator stressed.
The drug, which is taken daily around 30 minutes before going to bed, is a synthetic analogue of vasopressin that works by increasing the absorption of water through the kidneys, which leads to less urine production.
Its efficacy was established in two 12-week, randomised, placebo-controlled trials in 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 FDA said.
On the safety side, the drug does carry a boxed warning and a Medication Guide because it can cause low sodium levels in the blood (hyponatraemia), severe cases of which can be life threatening if not promptly addressed.
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.
Dublin, Ireland-based Allergan picked up exclusive rights to develop and commercialise the drug from Serenity Pharmaceuticals back in 2010.