FDA的药品评价和研究中心内骨，生殖和泌尿产品部主任Hylton V. Joffe，M.D.，M.M.Sc.说：“今天的批准提供在夜间过度生产尿成年有第一个FDA-批准的治疗选择帮助减低一夜醒来小便次数，” “重要的是知道Noctiva不是批准为所有原因的夜间排尿，所以患者应与他们的卫生保健提供者讨论他们的症状可能确定夜间排尿潜在原因和是否Noctiva对他们正确。”
Noctiva被Milford上市，总部宾州Renaissance Lakewood，LLC for Serenity Pharmaceuticals，LLC。
U.S. FDA Approves Serenity Pharmaceutical’s Noctiva™ (desmopressin acetate) – the First Drug Approved for the Treatment of Nocturia
U.S. Food and Drug Administration (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 percent 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, MD, 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 percent 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.
Important Safety Information and Indication for Noctiva (desmopressin acetate)
NOCTIVA™ is a vasopressin analog indicated for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least two times per night to void.
•Noctiva can cause hyponatremia, which may be life-threatening if severe.
•Noctiva is contraindicated in patients at increased risk of severe hyponatremia, such as patients with excessive fluid intake, illnesses that cause fluid or electrolyte imbalances, and in those using loop diuretics or systemic or inhaled glucocorticoids.
•Ensure serum sodium is normal before starting or resuming Noctiva. Measure serum sodium within seven days and approximately one month after initiating therapy or increasing dose, and periodically during treatment. More frequently monitor serum sodium in patients 65 years of age or older and in patients at increased risk of hyponatremia.
•If hyponatremia occurs, Noctiva may need to be temporarily or permanently discontinued.
Noctiva should not be used in patients with symptomatic congestive heart failure or uncontrolled hypertension because fluid retention can worsen these underlying conditions. Use of Noctiva should be discontinued temporarily in patients with certain nasal conditions such as colds or allergies until those conditions have resolved.
Noctiva is also not recommended for the treatment of nocturia in pregnant women. Nocturia is usually related to normal changes in pregnancy that do not require treatment with Noctiva. Noctiva™ should not be used in children.
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