NDASUBLINGUALTABLET
Approved
Jan 2011
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
3/8 — Basic
ABSTRAL (fentanyl citrate) by Sentynl Therapeutics is analgesia. First approved in 2011.
Drug data last refreshed 14h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ABSTRAL is a sublingual fentanyl citrate tablet approved in 2011 for breakthrough pain management in opioid-tolerant patients. It works as an opioid agonist, binding to opioid receptors in the central nervous system to produce rapid analgesia. The sublingual formulation enables faster onset compared to oral routes, making it suitable for acute pain episodes.
LOE Approaching
Product approaching loss of exclusivity signals team downsizing and shift from growth to maintenance strategies; limited hiring for new initiatives.
Mechanism of Action
analgesia. Other members of the class known as opioid agonists include substances such as morphine, oxycodone, hydromorphone, codeine, and hydrocodone.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (4)
Conversion From Fast Acting Oral Opioids to Abstral®
Started Feb 2011
8 enrolled
Pain
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
Career Relevance
Worked on ABSTRAL at Sentynl Therapeutics? 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.