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 10h ago · AI intelligence enriched 1mo 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 is a potent synthetic opioid agonist that works by binding to opioid receptors in the central nervous system to produce analgesia. The sublingual route enables rapid onset, making it suitable for episodic, severe pain episodes.
LOE Approaching
As LOE approaches, ABSTRAL faces moderate competitive pressure (30) with declining exclusivity; commercial teams should expect downsizing and transition focus toward lifecycle extension or post-LOE support roles.
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
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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.