NDASUBLINGUALTABLET
Approved
Jan 2011
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
4/8 — Partial
ABSTRAL (fentanyl citrate) by Sentynl Therapeutics is analgesia. Approved for breakthrough pain, cancer pain. First approved in 2011.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ABSTRAL is a sublingual fentanyl citrate tablet approved in 2011 for breakthrough pain management across multiple chronic pain conditions, including cancer pain, neuropathic pain, and severe traumatic injury. It functions as an opioid agonist, binding to opioid receptors in the central nervous system to rapidly deliver analgesia. The sublingual route enables faster absorption compared to oral opioids, making it particularly valuable for acute pain episodes in opioid-tolerant patients.
LOE Approaching
As a long-marketed opioid approaching loss of exclusivity, ABSTRAL faces increasing generic pressure and requires defensive commercial strategies focused on patient retention and brand loyalty.
Mechanism of Action
analgesia. Other members of the class known as opioid agonists include substances such as morphine, oxycodone, hydromorphone, codeine, and hydrocodone.
Indications (2)
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 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.