NDABUCCALFILM
Approved
Jul 2009
Lifecycle
LOE Approaching
Competitive Pressure
25/100
Clinical Trials
3
Data completeness
4/8 — Partial
ONSOLIS (fentanyl citrate) by Hikma is analgesia. First approved in 2009.
Drug data last refreshed 22h ago · AI intelligence enriched 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ONSOLIS is a buccal fentanyl citrate film approved in 2009 for analgesia in opioid-tolerant patients. It delivers rapid analgesia through transmucosal absorption via buccal delivery, leveraging fentanyl's potent mu-opioid agonist mechanism. The buccal film formulation enables faster onset compared to oral tablets while maintaining patient convenience.
LOE Approaching10mo to LOE
With LOE approaching in 2027 and competitive pressure rated at 25%, the brand team is likely in defensive positioning, focusing on customer retention and managed decline strategies rather than growth initiatives.
Mechanism of Action
analgesia.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (3)
Study to Evaluate the Efficacy and Safety of OraVescent Fentanyl Citrate Treatment for the Management of Breakthrough Pain in Opioid-Tolerant Patients With Noncancer-Related Chronic Pain
Started Aug 2006
120 enrolled
Pain
Study to Evaluate the Efficacy and Safety of ORAVESCENT Fentanyl Citrate for Management of Breakthrough Pain
Started Sep 2005
Chronic Low Back Pain
Study to Evaluate the Efficacy and Safety of ORAVESCENT Fentanyl Citrate for the Management of Breakthrough Pain
Started Sep 2005
120 enrolled
Chronic Neuropathic Pain
Why This Matters for Your Career
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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.