Noctiva, which is a vasopressin analog, is the first therapy for nocturia to get the FDA approval.
Serenity Pharmaceuticals CEO Samuel Herschkowitz said: “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.”
Noctiva should be sprayed into any one nostril of the patient just before bedtime.
Serenity said the nasal spray temporarily reduces production of urine which in turn removes the urge to urinate for many hours during sleep time.
The nasal spray comes with a boxed warning and a medication guide as it can reduce sodium levels in the blood.
Serenity stated that health care providers will have to check whether the sodium levels of the patient are normal before prescribing Noctiva besides following up on the same during the course of treatment.
The approval was based on positive results from two trials featuring over thousand patients. The randomized, placebo-controlled studies demonstrated considerable drop in the mean number of nocturic voids as well as a high patient percentage with 50% or more reduction in night time voids in comparison to placebo.
Serenity said it will terminate its global agreement for the development and marketing of the nasal spray with Allergan after a transition period of 90 days.
Following which, Serenity will take over full responsibility of Noctiva’s commercialization and continued development.
Image: US FDA approves Serenity Pharmaceutical’s Noctiva (desmopressin acetate) – the first drug approved for the treatment of nocturia. Photo: courtesy of Business Wire.