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 1h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ACTIQ is a transmucosal fentanyl citrate lozenge approved in 1998 for breakthrough pain management in opioid-tolerant patients. Fentanyl is a potent synthetic opioid that binds to mu-opioid receptors in the central nervous system, producing rapid analgesia through the oral mucosa. The product leverages innovative transmucosal delivery to achieve faster onset than oral administration.
LOE Approaching
Product is in decline phase with moderate competitive pressure (30%), indicating defensive positioning and potential team restructuring or consolidation around higher-priority assets.
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
Worked on ACTIQ at Teva? Share your interview experience or compensation data (+7 days Pro)
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.