NDAORALTABLET, DELAYED RELEASEPriority Review
Approved
Jul 2004
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
Priority Review
CAMPRAL (acamprosate calcium) by Forest Devices is understood. First approved in 2004.
Drug data last refreshed 13h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CAMPRAL (acamprosate calcium) is an oral delayed-release tablet approved in 2004 for maintaining abstinence in alcohol use disorder by restoring balance between glutamate and GABA neurotransmission. It is believed to reverse neuroadaptations caused by chronic alcohol exposure and reduce protracted withdrawal symptoms. The exact mechanism remains incompletely understood but appears to modulate excitatory-inhibitory neurotransmitter homeostasis.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30/100), signaling a contracting commercial organization and defensive market positioning.
Mechanism of Action
understood. Chronic alcohol exposure is hypothesized to alter the normal balance between neuronal excitation and inhibition. and studies in animals have provided evidence to suggest acamprosate may interact with glutamate and GABA neurotransmitter systems centrally, and has led to the hypothesis…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
CAMPRAL offers limited career growth opportunity given its approaching/past LOE status and mature market position with minimal clinical development. Roles on this product are primarily defensive and focused on maximizing margins through managed care contracting, generic defense, and patient support rather than launch or expansion activities.
Field Sales Representative (defensive)
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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.