Noctiva（醋酸去氨加压素[desmopressin acetate]）鼻腔喷雾剂——是第一个获美国FDA批准用于治疗夜间尿频（夜间多尿导致至少起夜2次）的药物
2017年3月3日美国食品和药品监管局批准Noctiva(醋酸去氨加压素[desmopressin acetate])鼻喷雾为成年由于情况被称为夜间多尿(在夜晚尿过产生)每夜至少醒两次小便。Noctiva是第一个被FDA-批准为这个情况治疗。
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。”
夜尿症(醒夜间小便)是一种症状可能被广泛不同情况所致，例如充血性心衰，控制差糖尿病，药物，或膀胱或前列腺的疾病。考虑Noctiva前，卫生保健提供者应评价每个患者对夜尿症可能的原因，和优化对夜间排尿可能有贡献的潜在情况的治疗。因为Noctiva仅被批准为被夜间多尿所致为有夜尿症成年，卫生保健提供者应确证在夜间用一个24-小时尿收集尿的过度产生，如人们未曽得到以前。卫生保健提供者还应被留心可能致夜尿症潜在情况，但使用Noctiva治疗不安全，例如过量饮液体或症状性充血性心衰。
每天用Noctiva，睡前约30分钟。每天作用通过增加通过肾水吸收，它导致较少尿产生。
在两项12-周，随机化，安慰剂-对照试验在1,045患者50岁和以上有由于夜间多尿夜尿症确定Noctiva的疗效。尽管这些试验显示用Noctiva与安慰剂比较一个平均小夜间排尿数减低，用Noctiva更多治疗能够至少减半他们的夜间排尿数，和用Noctiva治疗患者有更多夜有一次或更少夜间排尿。
Noctiva正在被批准有一个黑框警告和一个用药指南因为它可能致在血中低钠水平(低钠血症)。严重低钠血症可能是危及生命如它未被及时诊断和治疗，导致癫痫，昏迷，呼吸停止或死亡。
卫生保健提供者在开始Noctiva前应确认患者的钠水平是正常，和应应在一周内和开始治疗后约一个月和和其后定期地核查钠水平。对可能处于对低钠血症风险患者较低Noctiva剂量被建议作为起始剂量，例如老年人。处于严重低钠血症增加风险患者中不应使用Noctiva，例如有过量液体摄取的患者，已患病可能致液体或电解质不平衡患者，某些有肾损伤患者，和在利用某些药物，已知如袢利尿剂或糖皮质激素患者。
在有症状性充血性心衰或不能控制的高血压因为液体潴留可能恶化这些潜在情况患者中也不应使用Noctiva。在有某些鼻情况例如感冒或过敏反应患者应暂时地被终止Noctiva的使用直至那些情况已解决。
Noctiva也不推荐在妊娠妇女夜尿症为夜尿症治疗是通常与妊娠中正常变化相关不需要用Noctiva治疗。Noctiva不应在儿童中使用。
Noctiva在临床试验中的最常见副作用包括鼻不适，感冒症状(鼻咽炎)，鼻充血，打喷嚏，高或增加血压，背痛，鼻出血，支气管炎和眩晕。
尽管有其他FDA-批准的药物也含去氨加压素，那些药物没有一个被批准治疗夜尿症。
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.
WARNING: HYPONATREMIA
•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
http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201656lbl.pdf