February 26, 2020. The long-term complications of TOOKAD to treat low-risk prostate cancer are unclear. We believe that better research needs to be completed before approval, especially because the sponsor did not comply with FDA’s recommendations for the study.
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NCHR Testimony on Aximris as an Abuse-Deterrent Opioid for Long-Term Treatment
January 15, 2020. FDA should require sufficient evidence that this drug’s abuse-deterrent properties will result in meaningful reductions in abuse, misuse, and related adverse clinical outcomes.
Read More »NCHR Testimony on Tramadol and Celecoxib for Acute Pain Relief
January 15, 2020. There is absolutely no evidence that this combination drug with an opioid is as effective or more effective than a standard dose of just the NSAID.
Read More »NCHR Testimony on SABER-Bupivacaine for Post-Surgery Pain Relief
January 16, 2020. There is not good evidence that SABER-bupivacaine provides a meaningful benefit to patients, and certainly not proven that the benefits outweigh the possible risks. Most important, the sponsor has not proven that this formulation of the drug works better or is safer than the opioid, bupivacaine. Bupivacaine itself has been on the market for decades, is available as a generic, and does not have these new safety concerns. Thus, there is no reason to approve this drug just to have “another tool” when there is no evidence that it is a better tool than currently available options.
Read More »National Center for Health Research Statement on Oxycodegol Before the FDA Advisory Committees
January 14, 2020. This FDA hearing was about the risks and benefits of a new opioid, oxycodegol, for the management of chronic lower back pain. We pointed out that experts now agree that patients with chronic pain should not be started on opioids, which are less effective than other options.
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