The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and Drug Safety and Risk Management Advisory Committee (DSaRM) convened on September 14th.
The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and Drug Safety and Risk Management Advisory Committee (DSaRM) convened on September 14th, to review and discuss Purdue Pharma’s supplemental New Drug Application (sNDA 021306). The aim of this meeting was to evaluate the Butrans® (buprenorphine) transdermal system in pediatric patients, ages 7 – 16, for the management of pain severe enough to require daily, around-the-clock, opioid treatment for which alternatives are inadequate
Butrans was approved in 2010 for the management of moderate-to- severe chronic pain in adult patients requiring a continuous, around-the-clock opioid analgesic for an extended period of time. With the 2016 opioid class labeling, the indication was changed to the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate. At the time of approval, the pediatric study requirement for ages birth through six years was waived because necessary studies were impossible or highly impracticable since the numbers of pediatric patients meeting the indication were too small in number to make pediatric studies feasible. The pediatric study was deferred for ages 7 through 16 years because the product was ready for approval in adults. This deferred pediatric study was required under the Pediatric Research Equity Act (PREA) and was designed to assess the pharmacokinetics and safety of Butrans for the treatment of moderate-to-severe chronic pain requiring continuous, around-the-clock opioid treatment for an extended period of time in pediatric patients ages 7 through 16. Purdue Pharma is not seeking an indication for this population.
Given the small database size, there was not sufficient data to fully describe the safety profile and therefore, the FDA recommended that Butrans not receive an indication in pediatric patients. The Agency noted that data from the sponsor may warrant adding information about Butrans to the pediatric section of the labeling, without adding an indication for use in this population. The committees were asked to discuss the findings of the clinical study of Butrans conducted in pediatric patients, and whether they support additional labeling. In this meeting, there were three discussion questions and no voting questions.
Overall, the committees were concerned that the study of Butrans in pediatric patients did not have an adequate sample size and the patient population studied was not representative of all those who would receive treatment in the clinical setting, such as oncology and palliative care patients. Furthermore, the committee members stated that more data are needed to characterize the importance of body weight, potential safety signals, consequences of using additional QT prolonging products and the efficacy of the doses used in the study.
The committee members expressed mixed opinions on whether the study should be included in Section 8.4, Pediatric Use, in the Butrans label. Some members were concerned that inappropriate conclusions may be made about the study if it were added to the label, including assumptions that this is a robust study with adequate data for clinical decision-making. This may unintentionally deceive prescribers that do not thoroughly read the entire label. While other members expressed that including the study information in the label could be useful and valuable to prescribers. The consensus of the committee was that if the study is included in labeling, there should be clearly written statements about weight-based dosing, potential restrictions of use, limitations of the study, and contraindications along with a statement regarding the study’s lack of robust safety data.
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