NDAORALCAPSULE, DELAYED REL PELLETS
Approved
Jul 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
DRIZALMA SPRINKLE (duloxetine) by Fosun Pharma is antidepressant, central pain inhibitory and anxiolytic actions of duloxetine in humans are unknown, these actions are believed to be related to its potentiation of serotonergic and noradrenergic activity in the cns. First approved in 2019.
Drug data last refreshed 18h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DRIZALMA SPRINKLE is a delayed-release oral capsule formulation of duloxetine, an SNRI antidepressant approved in 2019. It works by potentiating serotonergic and noradrenergic activity in the central nervous system to treat depression, anxiety, and central pain conditions. The sprinkle formulation allows flexible dosing by opening the capsule and sprinkling pellets on food, expanding access to patient populations with swallowing difficulties.
$0.009BPart D
Peak10.7 years to LOEProduct is in peak revenue phase with modest Part D traction; commercial team size is likely stable with focus on differentiation and market expansion rather than rapid growth.
Mechanism of Action
antidepressant, central pain inhibitory and anxiolytic actions of duloxetine in humans are unknown, these actions are believed to be related to its potentiation of serotonergic and noradrenergic activity in the CNS.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Leveraging EEG for Antidepressant Prediction With Duloxetine and Bupropion
Started Oct 2020
0Major Depressive Disorder
Duloxetine to Prevent Oxaliplatin-Induced Peripheral Neuropathy in Patients With Stage II-III Colorectal Cancer
Started Jun 2020
220 enrolled
Stage II Colorectal Cancer AJCC v8Stage III Colorectal Cancer AJCC v8
A Study of Duloxetine Hydrochloride Hard Gelatinous Capsule Compared To Cymbalta
Started Mar 2020
0Healthy
A Study Of Duloxetine Hydrochloride Hard Gelatinous Capsule Compared To Cymbalta Under Fed Conditions
Started Mar 2020
0Healthy
A Study of Duloxetine (LY248686) in the Treatment of Japanese Children and Adolescents With Depressive Disorder
Started Jan 2018
151 enrolled
Depressive Disorder
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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.