NDASUBCUTANEOUSINJECTABLEPriority Review
Approved
Dec 1992
Lifecycle
LOE Approaching
Competitive Pressure
60/100
Clinical Trials
20
Data completeness
3/8 — Basic
Priority Review
Drug data last refreshed 11h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
IMITREX STATDOSE (sumatriptan) is a subcutaneous injectable triptan approved in 1992 for acute migraine treatment. It works as a selective 5-HT1B/1D receptor agonist to rapidly abort migraine attacks by constricting cranial blood vessels and inhibiting neuropeptide release. The STATDOSE formulation delivers rapid onset relief via subcutaneous self-injection.
LOE Approaching
As a mature product approaching loss of exclusivity with moderate competitive pressure (45), the brand team is likely focused on defending market share and optimizing operational efficiency rather than expansion.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A STUDY TO EVALUATE THE EFFECT OF PF-06651600 ON PHARMACOKINETICS OF SINGLE DOSE SUMATRIPTAN IN HEALTHY PARTICIPANTS.
Started Jun 2020
10 enrolled
Healthy Volunteers
Sofusa System With Sumatriptan (KC5010) Phase 1 Dose Escalation Safety and PK Study (KCC-SMT-002)
Started Jan 2018
19 enrolled
Migraine Disorders
A Study of Lasmiditan When Given With Sumatriptan in Healthy Participants
Started Oct 2017
40 enrolled
Healthy
Low-Dose Naltrexone and Acetaminophen Combination and Sumatriptan in the Acute Treatment of Migraine With Nausea
Started Jun 2017
36 enrolled
Migraine With and Without Aura
Effect of Single Oral Doses of Lasmiditan When Coadministered With Single Oral Doses of Sumatriptan in Healthy Participants
Started Mar 2017
42 enrolled
Migraine
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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.