First drug for frequent nighttime urination approved with black box warning

sleep 435x334 First drug for frequent nighttime urination approved with black box warningThe first drug approved by the Food and Drug Administration (FDA) to reduce nighttime trips to the bathroom will hit the market along with a black box warning for hyponatremia, a potentially fatal condition resulting from dangerously low levels of sodium in the blood.

Noctiva, made by Serenity Pharmaceuticals and Allergan, is a nasal spray intended for adults who wake up at least twice a night to urinate, a condition called nocturnal polyuria. It contains the active ingredient desmopressin acetate, a drug that is currently approved to treat other conditions including bleeding disorders. Noctiva is the first FDA-approved product to treat nocturnal polyuria.

Noctiva is not approved for all causes of nighttime urination. In fact, it was approved specifically for those who suffer from this common condition due to conditions such as chronic heart failure, poorly controlled diabetes, and bladder or prostate problems. Some medications can also cause frequent nighttime urination.

The nasal spray is used daily, about 30 minutes before bedtime. It works by making the kidneys absorb more, reducing the amount of urine that is produced. Before the drug is prescribed, health care professionals are advised to test patients to confirm they produce excess urine at night.

The drug was approved based on two randomized, placebo-controlled studies in 1,045 patients that showed the nasal spray helped reduce the number of nighttime bathroom trips in patients. The FDA granted approval of Noctiva, but required a black box warning – it’s most serious advisory – be included on the drug’s safety label regarding the risk of hypoatremia.

Severe hypoatremia can be life-threatening if not promptly diagnosed and treated, leading to seizures, coma, respiratory arrest, or death. Symptoms of hypoatremia are nonspecific and can include mental changes, headache, nausea, vomiting, muscle spasms, and seizures.

Other side effects associated with Noctiva include colds, bronchitis, increased blood pressure, dizziness, back pain and nose bleeds. There is no word from the drug companies when Noctiva will reach the market.

Source: PharmPro