NDAORALCAPSULEPriority Review
Approved
Dec 2004
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
LYRICA (pregabalin) by Viatris (2) is (pregabalin) binds with high affinity to the alpha 2 -delta site (an auxiliary subunit of voltage-gated calcium channels) in central nervous system tissues. First approved in 2004.
Drug data last refreshed 11h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LYRICA (pregabalin) is an oral small-molecule anticonvulsant that binds to alpha-2-delta subunits of voltage-gated calcium channels in the CNS, reducing pro-nociceptive neurotransmitter release and modulating pain pathways. It is indicated for neuropathic pain conditions, fibromyalgia, and partial-onset seizures. The mechanism involves disruption of calcium channel trafficking and potential modulation of descending noradrenergic and serotonergic pain control pathways.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30/100), suggesting contraction phase requiring cost-management and defensive positioning strategies on commercial teams.
Mechanism of Action
(pregabalin) binds with high affinity to the alpha 2 -delta site (an auxiliary subunit of voltage-gated calcium channels) in central nervous system tissues. Although the mechanism of action of pregabalin has not been fully elucidated, results with genetically modified mice and with compounds…
Indications
Worked on LYRICA at Viatris (2)? 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.