Varuna Srinivasan MBBS MPH, National Center for Health Research: October 12, 2018
Thank you for the opportunity to speak today. My name is Dr. Varuna Srinivasan. I am a physician with a Master of Public Health from Johns Hopkins University. I am a Senior Fellow at the National Center for Health Research, which analyzes scientific and medical data to provide objective health information to patients, health professionals, and policy makers. We do not accept funding from drug and medical device companies, so I have no conflicts of interest.
We have strong concerns about the safety of the drug in question today: Sufentanil.
First, we are concerned that the level of pain relief provided by sufentanil is not clinically meaningful. Patients taking the drug had statistically lower levels of pain than patients taking placebo based on their SPID score, but this difference was so small I would not consider it helpful to my patients. Just as important, there was no difference in how long it took for patients to experience “meaningful pain relief” between placebo and this drug that is supposedly five times more potent than fentanyl! If it was really more effective than placebo, surely it would work more quickly to relieve pain.
The weak results are even more problematic because there was only one pivotal phase 3 clinical trial. We have an opioid epidemic and it is crucial that the FDA not approve opioids that are not proven to work.
There is limited diversity in the clinical trials. Most of the study patients were white and younger. We would assume that a wide variety of patients visit the ER or undergo surgery, but that diversity of demographic background is not reflected in the study population. In fact, the FDA memorandum provides is no information on any racial and ethnic subgroups. They combined trials where they gave 15mcg and 30 mcg to different patients. These have different profiles but they controlled by the study sites and FDA finds it to be relevant. While there are no older patients in the trial with 30mcg, they are extrapolating the safety data as a whole and the mean age for the trial with 15 mcg is 58 so keeping this in mind, how do I phrase this sentence – The sponsor also failed to look at older patients, even though we know that pain tends to increase with age..
In summary, this drug is not proven to have a meaningful impact on reducing pain in post-operative settings. I respectfully urge you to let the FDA know that the agency should require better evidence of the efficacy of this drug. The sponsor should submit more conclusive data to this advisory committee before it can consider recommending approval for sufentanil.
On October 12th, the advisory committee voted 10-3 in favor of approving Sufentanil