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Bunavail was a prescription buccal film containing buprenorphine and naloxone. It was approved for maintenance treatment of opioid dependence and was placed against the inside of the cheek once daily. FDA withdrew approval of Bunavail on January 9, 2023 after the applicant reported that the product was no longer marketed and requested withdrawal of the application.
read more about bunavail ...Buprenorphine is a partial agonist at mu-opioid receptors and an antagonist at kappa-opioid receptors. Naloxone is a mu-opioid receptor antagonist. When taken through the prescribed buccal route, buprenorphine reduces withdrawal symptoms and opioid craving. Naloxone has greater antagonist activity when the combination is injected, which can precipitate withdrawal in people physically dependent on full opioid agonists.
The Bunavail applicant informed FDA that the product was no longer marketed and requested withdrawal of its new drug application. FDA withdrew approval on January 9, 2023. The withdrawal covered all three buccal film strengths, which contained 2.1 mg with 0.3 mg, 4.2 mg with 0.7 mg, or 6.3 mg with 1 mg of buprenorphine and naloxone.
Bunavail was applied to the buccal mucosa as a single daily dose. The recommended maintenance dose in its prescribing information was 8.4 mg of buprenorphine with 1.4 mg of naloxone daily. The film was placed against the inside of the cheek and kept in place until dissolved.
Serious risks included respiratory depression, misuse, physical dependence, neonatal opioid withdrawal syndrome, liver injury, adrenal insufficiency, allergic reactions, low blood pressure, and precipitated opioid withdrawal. Benzodiazepines, alcohol, and other central nervous system depressants increased the risk of profound sedation, respiratory depression, coma, and death. Bunavail was not intended for pain treatment.
No. FDA withdrew approval of Bunavail on January 9, 2023 after the applicant reported that it was no longer marketed.
Bunavail contained buprenorphine, a partial opioid agonist, and naloxone, an opioid antagonist.
Bunavail was placed against the inside of the cheek as a once-daily buccal film.
No. Its prescribing information stated that Bunavail was not appropriate as an analgesic.
BUNAVAIL (buprenorphine and naloxone buccal film) Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205637s000lbl.pdf. Date Accessed September 18, 2026.
Buprenorphine Hydrochloride; Naloxone Hydrochloride. PubChem. https://pubchem.ncbi.nlm.nih.gov/compound/Bunavail. Date Accessed September 18, 2026.
Buprenorphine Sublingual and Buccal (opioid dependence). MedlinePlus. https://www.medlineplus.gov/druginfo/meds/a605002.html. Date Accessed September 18, 2026.
DailyMed - BUNAVAIL (buprenorphine and naloxone) buccal film. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=12b963dd-f189-11e3-ac10-0800200c9a66. Date Accessed September 18, 2026.
Teva Branded Pharmaceutical Products R and D, Inc., et al.; Withdrawal of Approval of 35 New Drug Applications. Federal Register. https://www.federalregister.gov/documents/2022/12/08/2022-26661/teva-branded-pharmaceutical-products-r-and-d-inc-et-al-withdrawal-of-approval-of-35-new-drug. Date Accessed September 18, 2026.