The FDA has raised concerns about a proposed new treatment being produced by Allergan Plc to help treat the problem of frequent night-time urination. The US Food and Drug Administration carried out a first-stage review and found that the dosing levels had not been studied properly in clinical trials.
Allergan had proposed to start patients on the drug at a dose of 0.75 mcg, moving up to 1.5mcg as needed – however, this regimen went through no clinical trials for review. Additionally, data showed that efficacy was only possible at the higher dose. Additional findings from the reviewers raised concerns that the drug had no meaningful clinical value when compared against a placebo.
A Lower Dose of an Approved Drug
The SER120 drug is a nasal-spray taken at a lower dose than the more commonly prescribed alternative of desmopressin. It has been created to treat a disorder called nocturia which affects adults who need to get up at least two times at night to urinate.
As yet, the FDA has approved no drugs to treat this condition, despite there being a range of companies to help with FDA 510k processes such as www.fdathirdpartyreview.com and pharma companies looking to develop solutions.
The drug desmopressin was approved by the FDA in 1978 in order to treat patients suffering from a rare disorder called diabetes insipidus, which leads to a water imbalance in the body. It has since approved the drug for other uses. However, an oral version of the pill has twice been rejected for producing excessively low sodium levels in patients’ blood, which would present risks outweighing the potential benefits.
The government agency had charged Allergan will enrolling patients aged fifty and above to assess the risks of hyponatremia as part of the trial process for the new drug. However, the company failed to carry out sufficient testing across all age groups. During trials, there were five patient deaths, and the reviewers found that the drug could not be completely ruled out as a link to two of those deaths. Four of the patients who died during the trials were aged 75 or older.
Allergan Plc’s shares dipped on the morning of the news, and the company’s board is reviewing the FDA feedback to assess next steps.