Things aren't looking great for oxycodegol, a potential new pain drug that has been in Nektar Therapeutics' (NASDAQ:NKTR) late-stage pipeline for a long time. The FDA will discuss the slow-acting opioid's benefits in light of its risks with a panel of independent experts on Jan. 14, 2020, and recently released briefing documents prepared for the advisory committee aren't too encouraging.
Chronic pain intense enough to limit life and work activities affects roughly 20 million adults in the U.S. and for many that pain originates in the lower back. While millions of Americans that rely on powerful opioids to manage their chronic lower back pain (CLBP) would like a better treatment option, the FDA doesn't appear convinced oxycodegol fits the bill.
Risks versus benefits
Oxycodegol's key selling point is a central nervous system absorption rate that's much slower than often abused opioid drugs. It's currently regulated by the DEA as a Schedule 2 controlled substance and the FDA doesn't think it belongs in a less restrictive setting. That's partly because the data submitted shows oxycodegol's oral abuse potential is comparable to oxycodone.
In the FDA's briefing document we also learned that the agency advised Nektar Therapeutics to present two successful studies that show oxycodegol's benefits outweigh its risks among the larger chronic pain population. Instead, Nektar's attempting to earn approval for the smaller population of people with CLBP based on one successful trial.
Once you add it all up, the odds of a positive advisory committee meeting for the pharmaceutical company are very slim. Don't be surprised if the panel members decide it's best if Nektar applies again with more convincing data from a second pivotal study.