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 »Tag: opioid
NCHR Testimony on the Opioid Buprenorphine/Samidorphan for Depression
November 1, 2018. The clinical trial data do not provide adequate evidence that buprenorphine/samidorphan reduces the symptoms of depression. There are concerns about it potential for long-term harms to patients and others who might misuse or abuse it. BUP/SAM needs to provide strong evidence of efficacy before approval.
Read More »