On Medical Treatments & Products

March 27, 2018. Patients undergoing opioid withdrawal need non-opioid effective treatment alternatives. In order to ensure the we are doing more good than harm, the FDA must ensure that treatments show substantial evidence of effectiveness. Current data indicate that lofexidine can successfully provide short-term relief of patients’ opioid withdrawal symptoms following abrupt discontinuation. However, due to cardiac safety risks, this drug should not be indicated for individuals with existing cardiac conditions, and if approved, there should be a clear warning on the drug’s label. Finally, the sponsor has not provided sufficient evidence that lofexidine increases the likelihood that individuals will complete withdrawal treatment and, ultimately, move toward ending their physical dependence on opioids. We believe they must do so in order to receive this indication.

March 8, 2018. We are concerned that the clinical trial data do not adequately represent the real-world population of patients who will be likely to consider this drug. We strongly recommend more persuasive data including a more diverse group of patients before making a decision about supplemental approval of the two proposed dosing regimens for induction non-responders and those with prior TNF blocker failure.

February 15, 2018. It remains unclear whether individual achievement of abstinence is sustainable over time and whether long-term NRT use is more or less beneficial on an individual or population health level. We commend the FDA for addressing their role in developing strategies to evaluate NRT products and labeling. We agree that urgent action is necessary and the FDA should consider science-based approaches to reduce further harm from combustible tobacco products.

FDA, February 15, 2018. We need post-surgical pain treatments that spare patients from opioid use. However, at this time, the data are insufficient to recommend supplemental approval of Exparel.