An FDA panel has rejected the application for Buvaya sublingual buprenorphine spray. Their rationale? Risk of respiratory depression. FDA has rejected the safest opioid, buprenorphine, used around the world for treating acute pain and first approved in the U.S. for treating pain in injectable form in 1981 as Buprenex. The result? Prescribers will continue to turn to more dangerous and addictive hydrocodone, oxycodone and others, contributing to, instead of ameliorating, the opioid overdose crisis.
Subutex film remains the only preparation of buprenorphine conceivably usable (off label) to treat acute postop pain, and to use it the patient would have to cut a 2 mg. strip into 8-10 pieces to take every 4 hours. (Try cutting a 2 mg. tablet into 8 pieces.) The 2 mg. film, considered a low dose for treating addiction is much too high for use in opioid-naive patients.
FDA addressed risk of respiratory depression in, for example, Sublocade, with a simple warning:
"Use SUBLOCADE with caution in patients with compromised respiratory function (e.g., chronic obstructive pulmonary disease, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre‐existing respiratory depression)."
FDA has approved numerous other preparations of buprenorphine, including for treatment of chronic pain. Would they have us believe that dosing by sublingual spray in itself results in unacceptable risk in this long-acting drug?
We desperately need a drug like Buvaya. Can we really trust FDA's handling of new drug applications? Can pharma not rise to the challenge? Do laws that prevent marketing here of low dose preparations used in Europe for years really serve the American people?