FDA Okays Drug for Frequent Nocturia
By medpagetoday.com
For the first time the FDA approved a treatment for frequent nighttime urination due to overproduction of urine.
The drug, desmopressin acetate (Noctiva), is delivered as a nasal spray and is approved for use only in adults who awaken two or more times nightly to urinate due to nocturnal polyuria. Used daily "approximately 30 minutes before going to bed, it works by increasing the absorption of water through the kidneys, which leads to less urine production," the agency said.
In a statement, Hylton V. Joffe, MD, MMSc, of the FDA's Center for Drug Evaluation and Research, said, "It is important to know that Noctiva is not approved for all causes of nighttime urination, so patients should discuss their symptoms with their healthcare provider who can determine the underlying cause of the nighttime urination and whether Noctiva is right for them."
The FDA cautioned that nocturia can be caused by a wide variety of conditions, "such as congestive heart failure, poorly controlled diabetes mellitus, medications, or diseases of the bladder or prostate. Before considering Noctiva, healthcare providers should evaluate each patient for possible causes for the nocturia, and optimize the treatment of underlying conditions that may be contributing to the nighttime urination. Because Noctiva is approved only for adults with nocturia caused by nocturnal polyuria, healthcare providers should confirm overproduction of urine at night with a 24-hour urine collection, if one has not been obtained previously."
Moreover, the FDA warned that underlying conditions, including congestive heart failure, could make use of the drug unsafe.
Noctiva is taken daily, approximately 30 minutes before going to bed. It works by increasing the absorption of water through the kidneys, which leads to less urine production.
The approval was based on two 12-week, randomized, placebo-controlled trials in 1,045 patients 50 years of age and older with nocturia due to nocturnal polyuria. Both studies demonstrated only a small benefit compared with placebo, but "more patients treated with Noctiva were able to at least halve their number of nighttime urinations, and patients treated with Noctiva had more nights with one or fewer night-time urinations."
The drug will carry a boxed warning that it can cause hyponatremia, which can be life-threatening if severe.
"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," the FDA said. The drug should not be used in pregnant women or children.
Side effects included nasal discomfort, nasal congestion, sneezing, hypertension, nose bleeds, bronchitis, and dizziness.
Noctiva is marketed by Milford, Pennsylvania-based Renaissance Lakewood, LLC for Serenity Pharmaceuticals, LLC.
Source: http://www.medpagetoday.com/urology/urology/63578
Sunday, June 14, 2026
Metformin For Prediabetes: A Patient Guide
Prediabetes is a condition that affects a significant number of people and can range from mild and occasional to persistent and severely disruptive. Understanding the available treatment options is an important part of managing symptoms effectively. Healthcare providers evaluate the severity of the condition and the patient's overall health profile before recommending a specific medication or combination of treatments. Type 2 diabetes is a chronic metabolic condition characterized by elevated blood sugar levels resulting from a combination of insulin resistance and impaired insulin secretion. The pancreas produces insulin, the hormone responsible for helping cells absorb glucose from the bloodstream, but in type 2 diabetes the body's cells respond poorly to insulin and the pancreas cannot compensate fully with increased production. Over time, chronically elevated blood glucose damages blood vessels and nerves throughout the body. Metformin (metformin) belongs to the class of medications used for diabetes care and is commonly considered by clinicians evaluating treatment options for this condition. Patients looking closely at metformin for prediabetes will find that the medication offers a practical option for many individuals dealing with this specific issue, particularly when first-line approaches have provided incomplete relief. As with any prescription or over-the-counter medication, proper dosing and adherence to usage guidelines are essential to getting the most benefit from Metformin while minimizing the risk of side effects. Taking the medication as directed, at the appropriate time of day, and for the full recommended duration helps ensure therapeutic blood levels are maintained. Patients should inform their healthcare provider of all other medications they are taking to check for potential interactions. For broader context on treatment options related to diabetes care, diabetes care provides evidence-based information covering the full range of medications used in this therapeutic area, helping patients and caregivers compare approaches and make informed decisions alongside their medical team.
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