NDAORALTABLET
Approved
Jan 2011
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
6/8 — Strong
GRALISE (gabapentin) by Almatica Pharma is analgesia, gabapentin prevents allodynia (pain-related behavior in response to a normally innocuous stimulus) and hyperalgesia (exaggerated response to painful stimuli). Approved for postherpetic neuralgia, partial seizure disorder, restless legs syndrome. First approved in 2011.
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GRALISE is an extended-release oral tablet formulation of gabapentin, approved in 2011 for the treatment of postherpetic neuralgia (PHN). It works through a mechanism involving binding to voltage-activated calcium channel subunits and potentially antagonizing thrombospondin binding to α2δ-1 receptors, which prevents allodynia and hyperalgesia associated with neuropathic pain. Gabapentin does not act through GABA receptors or conventional neurotransmitter pathways despite its structural similarity to GABA. The product serves as a non-opioid option for chronic neuropathic pain management in the post-herpetic neuralgia indication.
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Mechanism of Action
analgesia, gabapentin prevents allodynia (pain-related behavior in response to a normally innocuous stimulus) and hyperalgesia (exaggerated response to painful stimuli). Gabapentin prevents pain-related responses in several models of neuropathic pain in rats and mice (e.g., spinal nerve ligation…
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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.