Allergan urological drug gets thumbs up from FDA panel
- Irish pharma major Allergan and partner Serenity Pharmaceuticals announced an independent advisory committee to the Food and Drug Administration had recommended approval for SER-120, a desmopressin nasal spray to reduce nighttime urination.
- Before the meeting, FDA staff had raised concerns about the clinical trials conducted in support of the drug, flagging issues wih the dosing regimen and patient selection.
- Even so, committee members voted 14-4 in favor of the benefit-risk profile and 17-1 to support the scientific evidence of the effectiveness of SER-120. A final decision from the FDA is expected in Q4 2016.
The FDA briefing document raised questions over the Phase 3 trials, which had extensive exclusion criteria, and "did not systematically assess whether a reduction in urine output at night could have adverse effects on other aspects of the underlying condition."
Earlier in development, the FDA had recommended Allergan conduct studies in patients older than 50, as they were the individuals most at risk of low sodium levels as a result of treatment. Allergan's application seeks approval for use regardless of age, however.
Staff also noted that only the 1.5 mcg dose of desmopressin was statistically superior to placebo on both co-primary endpoints. Allergan is proposing a starting dose of 0.75 mcg, however, according to Reuters.
The advisory committee reviewers took a more positive view of Allergan's evidence, however. While the FDA is not required to follow the advice of its advisory panels, it usually does so.
Allergan picked up the drug in 2010, signing a deal with Serenity to develop SER-120, then in Phase 3, covering all indications outside childhood bedwetting.
The underlying drug used in SER-120, desmopressin, has been around for decades. But last year the FDA recently turned down a melting tablet form of desmopression, Nocdurna, which had been developed by Ferring Pharmaceuticals.
Nocturia has potential to be a sizeable market in the U.S., especially as the population ages. Over one third of adults need to urinate at least twice in the night (the criteria for nocturia), and both Allergan and Serenity believe the condition to be underdiagnosed.
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