FDA OK's First Treatment for Nightly Urination

Mar 06, 2017

The U.S. FDA approved Noctiva (desmopressin acetate) nasal spray for adults who wake up at least two times per night to urinate due to a condition known as nocturnal polyuria (overproduction of urine during the night). Noctiva is the first FDA-approved treatment for this condition.

“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,” said Hylton V. Joffe, M.D., M.M.Sc., director of the Division of Bone, Reproductive, and Urologic Products in the FDA’s Center for Drug Evaluation and Research.

Nocturia (wakening at night to urinate) is a symptom that 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. The treatment is being approved with a boxed warning and a Medication Guide because it can cause low sodium levels in the blood (hyponatremia). The lower Noctiva dose is recommended as the starting dose for those who may be at risk for hyponatremia, such as the elderly.

Although there are other FDA-approved medications that also contain desmopressin, none of those medications are approved to treat nocturia.

Noctiva is manufactured by Renaissance Lakewood, LLC for Milford, Pennsylvania-based Serenity Pharmaceuticals, LLC.

Read the full FDA release

Show Comments
Hide Comments

Join the discussion

We welcome your thoughtful comments.
All comments will display your user name.

Want to participate in the discussion?

Register for free

Log in for complete access.

Comments

No one has commented on this page yet.

RSS feed for comments on this page | RSS feed for all comments