FDA panel gives the nod to Allergan’s night-time urinary drug

Allergan CEO Brent Saunders

An expert panel that advises the FDA has voted 14-4 that its experimental nocturia med be recommended for approval.

With the normal caveats that the U.S. regulator does not have to follow the advice of these panels, the decision bodes well for the recently acquisitive Allergan and its SER120--a low-dose nasal version of desmopressin, which is already used in a variety of conditions.

A few panelists however were not overly impressed with the efficacy of the candidate.

The med, bought from Serenity by Allergan for $165 million six years ago, is designed to help patients who have to urinate several times a night, although the panel said any approval should come for a smaller subpopulation whose nocturia is caused by an increase in total urine volume, rather than a general drug to stop frequent night-time urination regardless of diagnosis.

The FDA documents say that millions of these patients have two or more nocturic episodes per night, interrupting sleep and increasing the risk of falls in the elderly, who are typically more likely to have the condition.

Allergan’s Botox (onabotulinumtoxinA), used as an antiwrinkle treatment as well as for other medical conditions, has a license to treat so-called overactive bladder disorder and certain forms of incontinence.