FDA Approves Controversial Pain Drug
FDA has approved an AcelRx Pharmaceuticals resubmitted NDA for Dsuvia (sufentanil sublingual tablet, 30 micrograms) for treating moderate-to-severe acute pain in adult patients in medically supervised settings. In 10/2017, the agency issued a complete response letter on the original submission, asking for additional safety-related data from at least 50 patients dosed at the maximum amount described in the proposed labeling. Additionally, FDA said that to ensure proper administration of the tablet with the single-dose applicator, it recommended certain changes to the “Directions for Use” to address use-related errors, including dropped tablets, to be validated through a human factors study.
In an October letter (PDF) to FDA, Anesthetic and Analgesic Drug Products Advisory Committee chair Raeford Brown joined Public Citizen in urging the agency to reject the medication. The letter warned that Dsuvia would be abused and start killing people as soon as it hits the market. Dsuvia is five to 10 times more potent than fentanyl and 1,000 times more potent than morphine, the advocacy group says.
The drug was developed in collaboration with the Defense Department, primarily for use in a battlefield setting, an FDA statement notes. “Looking beyond this particular drug approval, I believe that we should consider whether we should be doing more to evaluate each candidate opioid, not just as an independent review decision, but rather also to consider each novel opioid drug in the context of the overall therapeutic armamentarium that’s available to patients and providers,” FDA commissioner Scott Gottlieb says. “As we look at the public health implications of each new approval, we should evaluate whether we need to take additional steps to systematically consider new opioids relative to the comparative benefit and risks of other opioids already on the market. We should consider whether we could do more in weighing approvals to ensure that new opioids are sufficiently better than existing drugs to justify their addition to the market in the context of the current crisis of abuse.”
Gottlieb notes that FDA is re-evaluating how it considers both the individual and public health impacts of new opioids as they are reviewed for approval. “To that end, I’ve asked the professional staff at the FDA to evaluate a new framework for opioid analgesic approvals; one that provides a transparent process to delineate clearly, eventually in new guidance, how we intend to consider the benefits and risks of these products in the context of this crisis,” he says.
“Such a framework,” he continues, “also would need to address the potential hurdles to product innovation. So, if we develop such a framework that takes into closer consideration the overall therapeutic armamentarium as we consider new opioid product approvals, and weighs new opioid approvals against the benefits and risks of existing drugs for the treatment of pain; then we’d also need to describe how we intend to characterize the benefits and risks of opioids, and what we believe the unmet medical needs are. In this way, innovators would know up front where the opportunities are for developing new drugs that meet the FDA’s standards for safety and effectiveness.”