NDAORALCAPSULE, EXTENDED RELEASE
Approved
Aug 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
10
Data completeness
6/8 — Strong
LOREEV XR (lorazepam) by Almatica Pharma is gamma-aminobutyric acid-a (gaba a ) receptors in the brain and enhances gaba-mediated synaptic inhibition. First approved in 2021.
Drug data last refreshed 1h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LOREEV XR is an extended-release oral capsule formulation of lorazepam, a benzodiazepine that enhances GABA-mediated synaptic inhibition in the central nervous system. The product treats anxiety disorders and related conditions through modulation of GABA-A receptors in the brain. This formulation represents an innovation in delivery technology for a well-established drug class.
$0.001BPart D
Peak7.5 years to LOEEarly-stage niche product in peak lifecycle phase with modest Part D adoption and small commercial footprint, suggesting lean commercial operations and focused brand teams.
Mechanism of Action
gamma-aminobutyric acid-A (GABA A ) receptors in the brain and enhances GABA-mediated synaptic inhibition.
Pharmacologic Class:
Benzodiazepine
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (10)
Lorazepam for the Treatment of Status Epilepticus or Repetitive Status Epilepticus in Japan
Started Nov 2014
26 enrolled
Status Epilepticus
Phase 1 Study to Characterize the Safety and Pharmacokinetics of Single Intravenous Dose of Lorazepam in Healthy Japanese Adult Subjects
Started Jan 2014
8 enrolled
Healthy
Evaluation of the Effects of Etifoxine 100 mg and Lorazepam 2 mg on Vigilance and Cognitive Functions in the Elderly
Started Dec 2013
31 enrolled
Healthy Volunteers
A Study of the Effect of LY2216684 on Lorazepam
Started Dec 2010
28 enrolled
Major Depressive Disorder
Efficacy and Safety Study Comparing Lorazepam and Diazepam for Children in the Emergency Department With Seizures (Status 2)
Started Feb 2008
259 enrolled
Status Epilepticus
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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.