The Center for Responsible Science (CRS) said it is shocking that the Federal Drug Administration (FDA) granted fast-track approval for a nasal spary based on a two-day study of 30 trial participants because it was fast-acting and later declined to label the drug fast-acting on approval.
Discussing the testing and approval of Janssen-manufactured Esketamine, a nasal spray drug used to treat depression, CRS director of research and regulatory policy Tamara Drake told FDA News that under the Food Drug and Cosmetics Act, Congress requires at least two adequate and well-controlled studies, each convincing on its own, to establish effectiveness.
"However, in this case FDA clearly only relied on limited trial data,” Drake said.
Reporting on the issue, the Daily Beast stated “Esketamine’s trajectory to approval shows—step by step—how drugmakers can take advantage of shortcuts in the FDA process with the agency’s blessing and maneuver through safety and efficacy reviews to bring a lucrative drug to market.”
CRS Director of Research and Regulatory Policy Tamara Drake
www.researchgate.net
Drake said FDA drug sponsors are typically required to provide data from at least two clinical trials demonstrating efficacy.
“It is unclear why FDA was so quick to approve a drug that was fast-tracked for a particular purpose, when the data clearly didn’t show that it lived up to the initial claims and presented safety issues,” she said.
At this point there isn’t sufficient data to know if the benefits of Esketamine outweigh the risks, according to Drake.
“With six deaths in Janssen’s limited clinical trials and uncompleted long-term studies of the benefits and risks, there is no way to know,” she said.
Anytime there are deaths in clinical trials, the CRS believes the FDA should err on the side of caution instead of approving a drug that could later prove to be harmful or ineffective, Drake noted.
“Asking questions is very important to make sure the physician is aware of the controversy surrounding this drug’s approval, including safety, abuse potential and possible withdrawal issues that haven’t been addressed,” she said.
