Citing efficacy and other concerns, a joint FDA advisory committee voted 18-1 not to recommend approval of Insys’ buprenorphine spray for acute pain.
Members who cast “no” votes cited the drugmaker’s data indicating safety problems and lack of efficacy. “This is an ineffective agent. It just doesn't work for 'post-op' acute pain in any way that any patient or provider would expect it to work," said committee member Steven Meisel of Fairview Health Services in Minneapolis.
FDA officials indicated that the shortest median time to meaningful pain relief in the pivotal trial was 92 minutes — longer than the hour in which patients generally expect pain relief to take effect. Committee members expressed concern that, in the interim, patients would take a different opioid or another dosage of the drug, which is only to be used every eight hours.