NDABUCCALFILM
Approved
Jul 2009
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
3
Data completeness
5/8 — Partial
ONSOLIS (fentanyl citrate) by Hikma is analgesia. Approved for breakthrough pain, cancer pain. First approved in 2009.
Drug data last refreshed 18h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ONSOLIS is a buccal film formulation of fentanyl citrate approved in 2009 for breakthrough pain in cancer patients. It works as a full opioid agonist providing rapid analgesia through transmucosal absorption. The product targets opioid-tolerant patients experiencing acute pain episodes despite baseline opioid therapy.
LOE Approaching1.2 years to LOE
Product is in final years of patent protection with declining commercial intensity; team resources likely shifting to transition planning and generic mitigation strategies.
Mechanism of Action
analgesia.
Indications (2)
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 the Management of Breakthrough Pain
Started Sep 2005
120 enrolled
Chronic Neuropathic Pain
Study to Evaluate the Efficacy and Safety of ORAVESCENT Fentanyl Citrate for Management of Breakthrough Pain
Started Sep 2005
Chronic Low Back Pain
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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.