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 4d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LYRICA (pregabalin) is an oral capsule that binds to alpha-2-delta subunits of voltage-gated calcium channels in the central nervous system to reduce neuropathic pain and seizure activity. It is indicated for fibromyalgia, epilepsy, diabetic neuropathy, postherpetic neuralgia, neuropathic pain, generalized anxiety disorder, and restless legs syndrome. The mechanism involves reducing calcium-dependent release of pro-nociceptive neurotransmitters and modulating descending pain pathways, though the full mechanism remains incompletely understood.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100); brand teams should expect revenue stabilization and transition focus to lifecycle management and defensive strategies.
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
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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.