Stephanie Fox-Rawlings, PhD, National Center for Health Research: October 11, 2018
Thank you for the opportunity to speak today on behalf of the National Center for Health Research. I am Dr. Stephanie Fox-Rawlings. Our Center 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.
New options for pain relief could benefit patients, especially if they are safer than current options. However, they need to be clearly demonstrated to be safe and effective before approval.
The data provided are not persuasive. It is not clear how well oliceridine works or under which conditions it works. The low dose was only effective in one of the two efficacy trials when analyzed by accepted pain endpoints. Since replication is the key in science, we can’t assume the lower dose is effective. Perhaps it might be effective for some patients, but the sponsor has not determined if that’s true, and if so, which types of patients? However, the discrepancy could indicate that the result was a fluke for one of the trials.
This drug has serious risks like all opioids. The rates of some adverse events varied between trials, which could suggest that some populations or surgical situations increase these risks.
Given the variation in effectiveness and in the risk for adverse events, it is difficult to conclude whether the benefit outweighs the risks.
The sponsor claims that their drug is safer than morphine. It is very important for you to challenge that claim because the clinical trials do not support it! Some adverse events occurred more often with morphine, but the sponsors are not comparing equivalent levels of pain relief. Overall, the dose dependency of adverse events and pain relief means that the data do not adequately address these claims.
We commend the sponsors for including relatively large number of black and Hispanic patients in the phase 3 clinical trials. However, there are very few patients who are male or over 65 years old. Differences in weight, comorbidities, and other characteristics could affect the efficacy and safety of the drug.
In conclusion, there are many unanswered questions about what dosages work and are safe for which patients under which conditions. We all know that is an epidemic of opioid use, so these questions must be answered before a decision is made about whether or not to approve oliceridine.
Seven members of the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) voted to recommend approval of oliceridine, while eight voted against approval.