NDABUCCALFILM
Approved
Jun 2014
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
3/8 — Basic
BUNAVAIL (buprenorphine hydrochloride; naloxone hydrochloride) by Ascentage Pharma is naloxone. First approved in 2014.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BUNAVAIL is a buccal film formulation combining buprenorphine (partial mu-opioid agonist) and naloxone (opioid antagonist) for opioid use disorder treatment. The naloxone component discourages misuse by precipitating withdrawal if injected, while buprenorphine provides maintenance therapy. The film delivery enables rapid onset and improved patient compliance compared to sublingual tablets.
Peak9.0 years to LOE
Product is in peak commercial stage with established market presence; expect stable team size focused on market maintenance and managed care optimization.
Mechanism of Action
naloxone. Buprenorphine is a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor. Naloxone is an opioid antagonist and produces opioid withdrawal signs and symptoms in individuals physically dependent on full opioid agonists when administered parenterally.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
Working on BUNAVAIL offers stability in a mature opioid maintenance therapy market with established reimbursement and prescriber relationships. Career growth will focus on market share defense, managed care negotiations, and operational excellence rather than clinical development.
Brand Manager
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.