FDA Mulling Trial Design Issues for Long-Term Opioids in Chronic Pain
To evaluate the long-term efficacy and tolerability of a representative extended-release (ER)/long-acting (LA) opioid in a 12-month placebo-controlled trial, FDA staff are considering an enriched enrollment randomized withdrawal (EERW) study design, they noted in a briefing document ahead of an advisory committee meeting. On Wednesday, the Anesthetic and Analgesic Drug Products Advisory Committee will consider […]