Despite the dosing warning issued by the Food and Drug Administration (FDA) earlier last week amid concerns about the product’s labeling, an independent panel commissioned by the agency recommended approval for a experimental oral painkiller. The panel’s 23-0 vote is a major win for Massachusetts-based Collegium Pharmaceuticals, and its potential breakthrough drug marketed as Xtampza. Although the FDA is not obligated to approve products based on a panel recommendation, approval usually follows. The FDA had already said it would rule on the final approval by October 12th. There does appear to be some concerns about the FDA’s sentiment towards the drug, as it should only be taken after eating. The FDA’s statement issued last Wednesday suggested changes to the warning label, citing that the drug does not achieve its maximum effect on an empty stomach which could increase the chance of abuse by persons whose pain persists after the recommended dosage. On Thursday, the FDA denied approval to Purdue Pharmaceuticals and a similar drug labeled Avridi over overdose and misuse concerns. That drug is required to be taken on an empty stomach.
Despite the warning issued last week, the panel was obviously impressed by the abuse-preventative features of the opioid painkiller. Calling it “a real advance, from what I can determine, in the issue of deterrence of opioid abuse,” panelist Raeford Brown, a professor of anesthesiology at the University of Kentucky joined many of his colleagues in marveling at the drug’s physical properties. As a form of the widely abused oxycodone family which also includes Oxycontin, The anti-abuse technology, which Collegium calls DETERx, is the fundamental component of its development of abuse-deterrent versions of other painkillers like hydrocodone and morphine. The DETERx features also make the drug easier to use for people who have trouble swallowing. The technology prevents the pill from getting sticky when wet, which also leads to its imperviousness. Panelist and assistant professor at Harvard Medical School Dr. Brian Bateman said, “We’ve seen data suggesting the prevalence of dysphagia is substantial in chronic pain patients. This will meet that clinical need.” Avridi also contained a similar anti-abuse formula.
The panel cited Collegium’s final clinical trial as another primary reason for the unanimous recommendation. University of Utah’s associate dean for pharmacy practice Dr. Linda Tyler said, “Having the phase 3 trial made all the difference in the world.” Dr. Bateman concurred, calling the results “compelling.” The study was a randomized withdrawal, double-blind, placebo-controlled, trial involving 387 patients with chronic back pain, nearly equally divided between taking Xtampza and a placebo. The group taking Xtampza had statistically lower pain ratings after the 12-week trial, while reporting very little variation of the drug’s effects regardless of level of food intake. No adverse events were reported among those with various diets. Even with the overwhelming approval by the panel, it remains to be seen if FDA will require labeling improvements as a precondition for approval.
Fierce Biotech – Damian Garde
Medscape – Alicia Ault
Reuters – Vidya L. Nathan