NDAORALSOLUTION
Approved
Sep 2020
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
QDOLO (tramadol hydrochloride) by Athena Bioscience is tramadol, an opioid agonist and inhibitor of norepinephrine and serotonin re- uptake. Approved for pain, low back pain, osteoarthritis and 4 more indications. First approved in 2020.
Drug data last refreshed Yesterday · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
QDOLO is an oral tramadol hydrochloride solution approved in 2020 for acute and chronic pain conditions including low back pain, osteoarthritis, and postoperative pain. It works through dual mechanism: μ-opioid receptor agonism and inhibition of norepinephrine and serotonin reuptake, with analgesia beginning within one hour and peaking at 2–3 hours. The active metabolite M1 is significantly more potent than the parent compound at opioid receptors.
Peak14.3 years to LOE
Product is at peak lifecycle stage with 14+ years of patent exclusivity remaining, suggesting stable commercial infrastructure and team size for established pain management franchise.
Mechanism of Action
tramadol, an opioid agonist and inhibitor of norepinephrine and serotonin re- uptake. Although the mode of action is not completely understood, the analgesic effect of tramadol is believed to be due to both binding to μ-opioid receptors and weak inhibition of re-uptake of norepinephrine and…
Indications (7)
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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.