FDA approves Noctiva for adults with nocturnal polyuria

The FDA has approved Noctiva, the first treatment for nocturnal polyuria for adults who awaken at least two times each night to urinate, according to a recent press release.

A once daily nasal spray taken roughly 30 minutes before going to bed, Noctiva (desmopressin acetate, Allergan, Serenity Pharmaceuticals) works by increasing the absorption of water through the kidneys, which leads to less urine production.

“[The] approval provides adults who overproduce urine at night with the first FDA-approved therapeutic option to help reduce the number of times a night they wake up to urinate,” Hylton V. Joffe, MD, MMSc, director of the division of bone, reproductive, and urologic products at the FDA’s Center for Drug Evaluation and Research, said in the release.

Researchers performed two 12-week, randomized, placebo-controlled trials to assess the efficacy of Noctiva in 1,045 patients aged 50 years and older with nocturia due to nocturnal polyuria. The results showed patients treated with Noctiva were able decrease the number of night-time urinations by at least half and had more nights with one or fewer night-time urinations.

Noctiva can cause hyponatremia, so health care providers should evaluate patient’s sodium level before prescribing the medication, then again after 1 week and 1 month after starting treatment with periodical checks thereafter. The FDA recommends that those at risk for hyponatremia, such as the elderly, start with a lower dose. Noctiva is not recommended for pregnant women, children, patients with congestive heart failure, uncontrolled hypertension and until certain nasal conditions such as cols and allergies are resolved. Common adverse effects include nasal discomfort, cold symptoms, nasal congestion, sneezing, high or increased blood pressure, back pain, nose bleeds, bronchitis and dizziness.

Because nocturia is a common symptom of many other conditions, including congestive heart failure, health care providers must carefully evaluate each patient and optimize the treatment of underlying conditions that may be contributing to the night-time urination before considering the nasal spray.

“It is important to know that Noctiva is not approved for all causes of night-time urination, so patients should discuss their symptoms with their health care provider who can determine the underlying cause of the night-time urination and whether Noctiva is right for them,” Joffe said in the release.

No information on the pricing structure for Noctiva was released, but it will be closely watched in the current health care environment.

Several pharmaceutical companies have been heavily criticized by the public and members of Congress over the last year for significant increases in pricing on long-standing medications most notably Mylan for its 400% increase for Epipen since 2009. Marathon Pharmaceuticals is facing similar criticism for pricing Emflaza (deflazacort), a steroid that recently added an indication for Duchenne Muscular Dystrophy, at $89,000 annually when it had previously been available for approximately $1,000 a year.

Desmopressin was first approved in 1978 and is available under the brand name DDAVP for the treatment of diabetes insipidus and bedwetting, and is generally available for less than $200 a month, according to drugs.com.

In a September 2016 blog post, Allergan CEO Brett Saunders derided dramatic price increases, saying that “aggressive or predatory price increases have violated [the] social contract” between the health care industry, patients, and physicians. Saunders pledged that Allergan would not engage in “price gouging actions or predatory pricing.”

Disclosure: Noctiva is marketed by Milford, Pennsylvania-based Renaissance Lakewood, LLC for Serenity Pharmaceuticals, LLC.