Serenity Pharmaceuticals announced that the FDA approved Noctiva (desmopressin acetate) nasal spray for the treatment of nocturia due to nocturnal polyuria in adults who awaken two or more times per night to urinate. This marks the first FDA-approved therapy for nocturia.

Noctiva is a vasopressin analog administered as a metered nasal spray in either nostril shortly before bedtime. It works by temporarily decreasing urine production and thereby reduces or eliminates the need to urinate for several hours while patients sleep. Noctiva was approved with a boxed warning and a Medication Guide because it can cause low sodium levels in the blood (hyponatremia).

Nocturia is a medical condition affecting tens of millions of adults. Medical experts and the FDA acknowledge that nocturia has many causes including enlarged prostate gland, overactive bladder, fluid accumulation in the legs and excessive fluid ingestion particularly at night. In more than 80% of patients with nocturia, regardless of the contributing factors, there is overproduction of urine during the night (nocturnal polyuria) resulting in frequent voiding and interrupted sleep. It can occur at any age but is most common in patients age 50 and older. Nocturia is associated with an increased risk of injury from falls, loss of sleep, fatigue and decreased quality of life during the daytime. Noctiva is approved for the treatment of nocturia due to nocturnal polyuria in adults.

"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. We worked closely with the FDA and the medical community to develop this important new medication, and we look forward to bringing it to patients in the near future,” said Samuel Herschkowitz, M.D., chief executive officer of Serenity Pharmaceuticals.

The approval of Noctiva was based on two randomized, placebo-controlled studies in 1,045 patients which showed significant reductions in the mean number of nocturic voids and a significantly higher percentage of patients experiencing a 50% or greater decrease in night time voids compared to placebo. In addition, Serenity developed and validated the first patient-reported outcome measure specific to nocturia in compliance with the FDA 2009 guidance to assess quality of life in patients with nocturia and demonstrated a significant level of self-reported improvement in patients treated with Noctiva compared to placebo.

Noctiva can cause low sodium levels in the blood (hyponatremia). Severe hyponatremia can be life-threatening if it is not promptly diagnosed and treated, leading to seizures, coma, respiratory arrest or death.

Health care providers should make sure the patient’s sodium level is normal before starting Noctiva, and should check sodium levels within one week and approximately one month after starting treatment and periodically thereafter. The lower Noctiva dose is recommended as the starting dose for those who may be at risk for hyponatremia, such as the elderly. Noctiva should not be used in patients at increased risk of severe hyponatremia, such as those with excessive fluid intake, those who have illnesses that can cause fluid or electrolyte imbalances, certain patients with kidney damage, and in those using certain medicines, known as loop diuretics or glucocorticoids.

Serenity and Allergan have agreed to terminate their global agreement for the development and commercialization of Noctiva following a 90-day transition period. Moving forward, Serenity will be responsible for commercialization and continued development of the product.