New Products

Allergan scores an FDA OK for a new drug targeting night-time urination

Allergan has scored a new drug approval. But don’t feel bad if you missed the news late last week. This has been a low-profile development effort with a long stretch in late-stage development.

Allergan signed a commercialization deal with Serenity Pharmaceuticals back in 2010 for SER-120, a nasal spray therapy developed to treat a condition known as nocturnal polyuria, the overproduction of urine at night which can interrupt sleep with too many trips to the toilet. The FDA signed off on the approval on Friday, setting up a launch for this drug as Noctiva.

According to its web site, Serenity is devoted exclusively to Noctiva, and Allergan highlights the drug in its portfolio of four experimental urology programs. And it’s hitting the market with a black box warning raising a red flag about the risk of dangerously low sodium levels.

The drug works by increasing the absorption of urine in the kidneys, with a night time dose intended to limit its effect to sleep time. An FDA panel signed off — in a 14-to-4 vote — last fall, saying that the drug helped reduce the number of night-time urinations by one or two. But a number of experts also expressed concern that the drug could be dangerous among patients — particularly the elderly — with congestive heart failure or hypertension.

Hylton Joffe, FDA

Doctors are advised to test potential patient’s sodium levels before starting treatment and then periodically thereafter.

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

 

 


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RAPS Regulatory Convergence 2017