NDATRANSMUCOSALTROCHE/LOZENGE
Approved
Nov 1998
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
6
Data completeness
4/8 — Partial
ACTIQ (fentanyl citrate) by Teva is analgesia. First approved in 1998.
Drug data last refreshed 17h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ACTIQ is a transmucosal fentanyl citrate lozenge approved in 1998 for breakthrough pain management. It delivers potent opioid analgesia through the oral mucosa, enabling rapid systemic absorption. The product represents a specialized formulation within the opioid analgesic class.
LOE Approaching
Late-stage product with declining exclusivity; brand teams are transitioning to defensive strategies and post-LOE planning.
Mechanism of Action
analgesia.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (6)
Extension Study of ACTIQ Treatment for Children and Adolescents With Breakthrough Pain
Started Oct 2006
PainCancerSickle Cell Anemia+1 more
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
Evaluate the Efficacy and Safety of ACTIQ in Patients With Cancer and Breakthrough Pain
Started Jun 2004
Breakthrough 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.