Despite the dosing concerns, however, the advisory panel voted 23-0 in favor of recommending Xtampza for approval. The FDA generally follows the advice of advisory panels, although it is not obligated to do so. While the FDA stated days prior to the panel meeting that Collegium’s packaging should contain a clearer warning about the dosing issue, it did not explicitly state that approval was contingent on labeling improvements.
The highly anticipated October 12th Food and Drug Administration (FDA) review of Xtampza, made by Collegium, has been mysteriously delayed. The drug is a pioneering oxycodone oral medication containing physical properties that make it difficult to abuse. Containing Massachusetts-based Collegium’s patented DETERx technology, the drug cannot be crushed for snorting or melted down for injecting, and it will not get sticky after getting wet. The latter feature also benefits individuals who have difficulty swallowing. According to the U.S. Center for Disease Control and Prevention, opioid abuse has been labeled as an “epidemic” since 2011, killing roughly 44 people per day. In addition to several additional product offerings from Collegium containing DETERx technology, other drug makers such as Pernix Therapeutics, Pain Therapeutics, KemPharm, Egalet, and Acura Pharmaceuticals are also developing abuse-deterrent painkillers. Collegium failed to provide additional information as to what caused the delay or why, only that the FDA told the company that “will not be able to complete its review” by Monday’s scheduled deadline.
The company’s CEO Michael Heffernan said in a statement, “We are confident in the Xtampza ER program and our NDA submission. We continue to work closely with the FDA as they complete their review.” The FDA accepted Xtampza’s application for review in February; however, the agency issued a dosing warning that the drug must be taken after eating in order to achieve the full benefit just days before the drug’s review before an independent FDA advisory panel last month. The warning came in the wake of the FDA’s denied approval of a similar opioid, Purdue Pharmaceutical’s Avridi, which was required to be taken on an empty stomach. The FDA warned that if Xtampza is taken without food, it will lead to inadequate pain control, and contribute to abuse and overdose by users who are seeking to remedy their pain. For most opioid medications, the level of food intake does not influence the drug’s effectiveness.
Despite the dosing concerns, however, the advisory panel voted 23-0 in favor of recommending Xtampza for approval. The FDA generally follows the advice of advisory panels, although it is not obligated to do so. While the FDA stated days prior to the panel meeting that Collegium’s packaging should contain a clearer warning about the dosing issue, it did not explicitly state that approval was contingent on labeling improvements. The advisory panel also did not bring labeling concerns to the forefront of its meeting, instead citing the exceptional results of Xtampza’s third and final clinical trial, presenting zero adverse-effects and a statistically significant improvement in pain management among a 387-patient Phase III trial. Panelists were universal in their praise of the drug’s anti-abuse characteristics, with Harvard Medical School’s Dr. Brian Bateman calling the trial “compelling,” and University of Kentucky professor of anesthesiology Raeford Brown calling Xtampza, “a real advance, from what I can determine, in the issue of deterrence of opioid abuse.” Still, the delay raised concerns among investor circles as shares of Collegium dropped eight percent in overnight trading Monday, as some analysts speculate if the labeling issue remains a sticking point with the regulator. Collegium raised $80 million in a May IPO, largely due to Xtampza’s promising forecast.
Fierce Biotech – Damian Garde
Northern Californian – Caroline Robinson
Reuters – Rosmi Sanji