FDA Advisory Committee Opposed to Buprenorphine Sublingual Spray

Posted by on July 27, 2018

On May 22nd, 2018 a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee discussed the new drug application (NDA) 209588 for buprenorphine sublingual spray (Buvaya), submitted by INSYS Development Company Inc. The drug is an opioid receptor indicated for the treatment of moderate-to-severe acute pain where the use of opioid analgesics is appropriate. The sponsor’s proposed doses were 0.125 mg, 0.25 mg and 0.5 mg per spray, three times daily.

The sponsor utilized previous studies with approved buprenorphine formulations and conducted additional safety, efficacy and pharmacokinetic studies in adults. One clinical trial using a 1 mg dose was stopped due to adverse events. The shortest median time to significant pain relief for postoperative patients was 92 minutes in the pivotal trial. Panel members noted that this would not be quick enough and that patients might be better off using alternatives. Others stated that the long onset of the drug could be considered a safety issue. However, many committee members noted the drug had a safer abuse profile than opioids and other postoperative analgesics.

The panel was presented 3 discussion question and 1 voting question. When asked whether Buvaya’s benefits outweighed its risks for the proposed indication, the committees voted 1 (Yes) to 18 (No). The late onset of analgesia and the high rate of adverse events were the most significant issues raised by the panelists. The panelist who voted  ‘Yes’ expressed that the drug has low abuse potential and there is a lack of alternative treatments on the market.  The agency is not obligated to follow its panel’s recommendation, but normally does so.

ISS has almost two decades of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net

This post was authored by Sami Mourad. Sami is a summer intern at ISS and a 3rd year pharmacy student at the Rutgers University Ernest Mario School of Pharmacy.


Do you have an upcoming Advisory Committee Meeting?

  • This field is for validation purposes and should be left unchanged.