It’s become a running gag, along with aching joints and memory loss: One of the worst aspects of aging is having to get up in the middle of the night many times to pee. But for people who end up sleep-deprived, it’s no joke.
Now a Missouri pharmaceutical company says it has a new medication that could help those who are 50 and older with the problem.
“There are an awful lot of patients for whom getting up that many times a night is really detrimental to their health, and for those patients for the first time they have a drug to prevent that,” said Michael Anderson, the CEO of Avadel Pharmaceuticals.
The drug, Noctiva, is a nasal spray that works on the kidneys to slow the production of urine. Avadel, which is headquartered in Ireland but has most of its commercial operations in Chesterfield, Mo., purchased it from the drug’s developers last year after the the U.S. Food and Drug Administration approved it in March.
Anderson said that since then, Avadel has been doing market research, scaling up production, hiring a sales force and looking for urologists who might be interested in prescribing Noctiva. The company is planning a “soft launch” in the next couple of weeks and Anderson expects the drug to be widely available by April or May.
“We’ve been working nonstop to get those things taken care of so when we start distribution we will have all of our ducks in a row,” Anderson said.
Anderson said drugs on the market now can treat other causes of frequent urination, like overactive bladder, but this is the first one the FDA has approved specifically to treat nocturia, the medical term for excessive urination at night.
The FDA flagged one potential serious side effect of Noctiva. Clinical trials showed a risk of hyponatremia, or low levels of sodium in the blood. If severe enough, hyponatremia can cause seizures, coma or even death.
That led the FDA to place a “blackbox” warning on the medication, urging doctors to measure sodium levels before and during treatment and discontinue the drug if hyponatremia occurs.
During clinical trials 1,045 people were treated with either Noctiva or a placebo. Four who took Noctiva experienced decreased blood sodium levels, including one who got a serious case of hyponatremia. There was also one in the placebo group that had decreased blood sodium that was considered serious.
Anderson said the company estimates there’s 40 million Americans who have nocturia and as research uncovers more negative health effects from lack of sleep, it’s also spurring more investigation into how many trips to the bathroom are really “normal.”
“I think there’s a growing body of evidence to support the notion that just because you turn 50 or 55 or 60 doesn’t mean you should have to get up three or four times a night,” Anderson said. “If you’re one of the many patients who get up multiple times and you end up having quality of life issues because of that, this is a drug you might want to talk to your urologist about.”