NDATOPICALSOLUTION
Approved
Nov 2009
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
20
Data completeness
5/8 — Partial
PENNSAID (diclofenac sodium) by Amgen is (ak) is unknown. First approved in 2009.
Drug data last refreshed 15h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PENNSAID is a topical diclofenac sodium solution approved in 2009 for localized pain relief. It is a nonsteroidal anti-inflammatory drug (NSAID) delivered via topical application to reduce inflammation and pain at the site of application. The mechanism of action involves inhibition of cyclooxygenase enzymes, though the exact mechanism for the topical formulation remains incompletely characterized.
$0.135BPart D
Peak4.1 years to LOEPeak sales of $135M in 2023 with 41,784 Part D claims indicate a stable mature franchise with established commercial infrastructure and team.
Mechanism of Action
(AK) is unknown.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study of Tirbanibulin Ointment and Diclofenac Sodium Gel for the Treatment of Adult Participants With Actinic Keratosis on the Face or Scalp
Started Oct 2022
447 enrolled
Keratosis, Actinic
To Evaluate the Superiority of Fixed Combination (Orfenadrine 35mg, Acetaminophen 325mg, Caffeine 65mg and Diclofenac Sodium 50mg) Compared to Voltaren® (Diclofenac Sodium 50mg) in the Treatment of Acute Postural Low Back Pain.
Started Jan 2021
110 enrolled
Postural Low Back PainMechanical Low Back Pain
A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study Comparing Diclofenac Sodium Gel, 3% to Solaraze® Gel, 3% in the Treatment of Actinic Keratosis on the Face or Bald Scalp
Started Oct 2015
492 enrolled
Actinic Keratosis
Efficacy and Safety of Ingenol Mebutate Gel 0.015% Compared to Diclofenac Sodium Gel 3% in Subjects With Actinic Keratoses on the Face or Scalp
Started Apr 2015
502 enrolled
Actinic Keratosis (AK)
Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Compared to Placebo in Subjects With Acute Blunt Trauma Injuries
Started Dec 2014
215 enrolled
Acute Blunt Soft Tissue Injuries/Contusions
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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.