diclofenac sodium topical solution 2% / Generic mfg. - LARVOL DELTA

Comparative Bioavailability of Smartech 2% Sodium Diclofenac Topical Solution and PENNSAID 2% Applied to the Knees of Healthy Male and Female Subjects (ANZCTR) - P1 | N=32 | Completed | Sponsor: Avance Clinical Pty Ltd | Initiation date: Oct 2000 ➔ Oct 2022

Trial initiation date • Immunology • Osteoarthritis • Pain • Rheumatology

Alembic Pharma Osteoarthritis Drug Gets USFDA Okay (Medical Dialogues) - "Alembic Pharmaceuticals Limited today announced that the company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Diclofenac Sodium Topical Solution USP, 2% w/w. The ANDA was filed by Aleor Dermaceuticals Limited which was amalgamated with Alembic. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pennsaid Topical Solution, 2% w/w, of Horizon Therapeutics Ireland DAC."

ANDA • CNS Disorders • Osteoarthritis • Pain

USFDA approves Lupin’s generic version of Pennsaid for arthritic knee pain (Financialexpress) - "Global pharma major Lupin Limited on Thursday announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Diclofenac Sodium Topical Solution USP, 2% w/w to market a generic equivalent of Pennsaid Topical Solution, 2% w/w of Horizon Pharma Ireland DAC."

ANDA • CNS Disorders • Osteoarthritis • Pain

Evaluate the Ability of dOFM for BE Testing of Topically Applied Diclofenac Sodium Products in Healthy Subjects (clinicaltrials.gov) - P=N/A | N=22 | Completed | Sponsor: Joanneum Research Forschungsgesellschaft mbH | Recruiting ➔ Completed

Trial completion

Miravo Healthcare Announces Second Quarter 2022 Results (Businesswire) - "Nuvo Pharmaceuticals Inc...d/b/a Miravo Healthcare (Miravo or the Company)...announced its financial and operational results for the three and six months ended June 30, 2022....Miravo’s U.S. partner for Pennsaid 2% announced it would be winding down the business segment that currently promotes and sells Pennsaid 2% in the U.S. in response to the market erosion resulting from an at-risk launch of a generic version of Pennsaid 2% in May 2022....The Company anticipates that a wind-down of its manufacturing operations may take 9 - 12 months, depending on various factors, some of which are beyond the Company’s control."

Discontinued • CNS Disorders • Osteoarthritis • Pain

HORIZON THERAPEUTICS PUBLIC LTD CO MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS (form 10-Q) (Market Screener) - "PENNSAID 2%. Net sales decreased $25.3 million, or 52%, to $23.6 million during the three months ended June 30, 2022, from $48.9 million during the three months ended June 30, 2021....DUEXIS. Net sales decreased $22.0 million, or 100%, to $0.1 million during the three months ended June 30, 2022, from $22.1 million during the three months ended June 30, 2021..."

Sales • Ankylosing Spondylitis • Back Pain • CNS Disorders • Osteoarthritis • Pain • Rheumatoid Arthritis

Miravo Healthcare Provides an Update on the United States Pennsaid 2% Business (Businesswire) - "Nuvo Pharmaceuticals Inc...d/b/a Miravo Healthcare...today announced that it has become aware that the United States’ Food & Drug Administration (FDA) approved Apotex Inc.’s abbreviated new drug application for a generic version of Pennsaid 2% on May 6, 2022. Miravo’s partner in the United States owns the Pennsaid 2% intellectual property rights in the United States and has carriage and full decision-making authority with respect to any litigation related to this matter."

ANDA • CNS Disorders • Osteoarthritis • Pain

HORIZON THERAPEUTICS PUBLIC LTD CO – 10-K – Management’s Discussion and Analysis of Financial Condition and Results of Operations (Insurancenewsnet) - "PENNSAID 2%. Net sales increased $13.6 million, or 8%, to $191.6 million during the year ended December 31, 2021, from $178.0 million during the year ended December 31, 2020....DUEXIS. Net sales decreased $51.3 million, or 41%, to $74.0 million during the year ended December 31, 2021, from $125.3 million during the year ended December 31, 2020....VIMOVO. Net sales decreased $29.2 million, or 78%, to $8.4 million during the year ended December 31, 2021, from $37.6 million during the year ended December 31, 2020."

Sales • Ankylosing Spondylitis • CNS Disorders • Immunology • Osteoarthritis • Pain • Rheumatoid Arthritis

HORIZON THERAPEUTICS PUBLIC LTD CO MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS (form 10-Q) (Market Screener) - "PENNSAID 2%. Net sales decreased $2.3 million, or 5%, to $48.0 million during the three months ended September 30, 2021, from $50.3 million during the three months ended September 30, 2020. Net sales decreased by approximately $5.9 million due to lower sales volume, partially offset by an increase of approximately $3.6 million resulting from higher net pricing primarily due to lower utilization of our patient assistance programs."

Sales • CNS Disorders • Osteoarthritis • Pain

Topical Diclofenac Solution for Osteoarthritis of the Knee: An Updated Meta-Analysis of Randomized Controlled Trials. (PubMed, Biomed Res Int) - "The safety of topical diclofenac solution was similar to the vehicle control, apart from adverse events involving application-site skin reactions. Topical diclofenac solution is effective and safe for use in patients with knee OA, but may cause minor skin reactions."

Journal • Retrospective data • Immunology • Osteoarthritis • Pain • Rheumatology

Nanosuspensions and Microneedles Roller as a Combined Approach to Enhance Diclofenac Topical Bioavailability. (PubMed, Pharmaceutics) - "Finally, DCF nanosuspensions were applied on newborn pig skin (in vitro) in combination with microneedles roller treatment, assessing the DCF penetration and distribution in the different skin layers. The relative contribution of microneedle length, nanosuspension stabilizer and application sequence could be identified by systemically varying these parameters."

Journal

The burden of musculoskeletal pain and the role of topical Non-steroidal anti-inflammatory drugs (NSAIDs) in its treatment. Ten underpinning statements from a global pain faculty. (PubMed, Curr Med Res Opin) - "The document considers the place of topical therapies alongside other pharmacological and non-pharmacological treatments and presents the evidence for the benefits and harms of topical NSAIDS including indicators of efficacy for three main topical NSAIDs-diclofenac, ibuprofen and ketoprofen-based on almost 15,000 participants in randomised controlled trials for acute and chronic musculoskeletal pain. Finally the gaps in knowledge are considered with suggestions on how further research might help. The global pain faculty was brought together by GSK under an unrestricted educational grant."

Clinical • Journal • Musculoskeletal Diseases • Musculoskeletal Pain • Pain

Comparison of Skin Permeation and Putative Anti-Inflammatory Activity of Commercially Available Topical Products Containing Ibuprofen and Diclofenac. (PubMed, J Pain Res) - "This study examined the skin absorption of representative commercially available topical diclofenac- and ibuprofen-based formulations along with published potency values to determine formulations with superior anti-inflammatory activity. Both absorption and COX-2 inhibition potency are important for anti-inflammatory activity, but their priority depends upon the products being compared-with the same NSAID, absorption determines superiority; with different NSAIDs, superiority is determined by the balance between absorption and COX-2 potency. These findings should be considered when selecting a topical NSAID for treating patient pain and inflammation."

Journal • Immunology • Inflammation • Pain

[VIRTUAL] Profile of Topical Diclofenac Sodium Gel 1% (Voltaren®) Users in a United States Longitudinal Electronic Health Records Database (ACR-ARHP 2020) - "The >500,000 DSG users in this retrospective study were generally older, more likely to be female, and had baseline comorbidities and risk factors of interest. Over half had a history of NSAID or opioid use at baseline. This study found that few DSG users (< 15%) had any single EOI despite baseline comorbidities and risk for these events, and that the EOIs on average occurred after the last prescription fill when DSG was no longer being used."

Cardiovascular • Diabetes • Gastrointestinal Disorder • Genetic Disorders • Hypertension • Immunology • Lupus • Metabolic Disorders • Musculoskeletal Diseases • Obesity • Osteoarthritis • Pain • Renal Disease • Rheumatology

Horizon Therapeutics plc Reports Record Third-Quarter 2020 Results; Increases TEPEZZA Full-Year Net Sales Guidance to Greater Than $800 Million; Increases Full-Year 2020 Net Sales and Adjusted EBITDA Guidance (Businesswire) - "Inflammation Segment (in millions ($) except for percentages): Q3 2020: PENNSAID 2%®: 0.3; DUEXIS®: 27.9; VIMOVO®: 5.3."

Sales • Back Pain • CNS Disorders • Osteoarthritis • Pain

IN BRIEF: Supreme Court won't hear Horizon appeal over arthritis gel patents (Reuters) - "The U.S. Supreme Court has declined to hear an appeal by Horizon Pharma of an Federal Circuit Court of Appeals decision that invalidated five of its patents on Pennsaid 2%, an NSAID gel for osteoarthritis of the knee."

Patent • CNS Disorders • Osteoarthritis • Pain

[VIRTUAL] Pharmacoeconomic Benefits of over-the-Counter Topical Diclofenac in the Treatment of Mild-to-Moderate ACUTE PAIN or Injury and Short-TERM PAIN Associated with Chronic Conditions in Germany (ISPOR-EU 2020) - "METHODS : The analysis compares topical diclofenac OTC as first-line treatment with an indication-specific mixture of alternative OTC treatments (Topical Ibuprofen, comfrey-based topical, heatwraps, Systemic Ibuprofen, or other Systemic OTC)...The chronic indication showed a 4.9% increase in costs (€10,383,830) but provided an additional 1,724.1 QALYs. For the both acute and chronic indications topical diclofenac OTC was associated with fewer work productivity hours lost, days not at full health, and physician visits.CONCLUSIONS : Use of topical diclofenac OTC vs. alternate OTC treatment mixtures as first-line treatment in Germany results in either cost savings (acute indication) or a relatively low incremental cost for the number of additional QALYs generated, with work productivity benefits and reduced use of healthcare resources."

HEOR • Pain

[VIRTUAL] Pharmacoeconomic Benefits of over-the-Counter Topical Diclofenac in the Treatment of Mild-to-Moderate ACUTE PAIN or Injury in Sweden (ISPOR-EU 2020) - "METHODS : The analysis compares use of topical diclofenac OTC as a first-line treatment option with a mixture of alternative OTC treatments (Topical Ibuprofen, Systemic Paracetamol, or other Systemic OTC)...topical diclofenac OTC was associated with 995,348 fewer work productivity hours lost, 2,903,097 fewer days not at full health, and 414,728 fewer physician visits. CONCLUSIONS : Use of topical diclofenac OTC vs. alternate OTC treatment mixtures as a first-line treatment for mild-to-moderate acute pain or injury in Sweden results in cost savings, work productivity benefits, and reduced use of healthcare resources."

HEOR • Pain

Comparative evaluation of topical diclofenac sodium vs topical Ibuprofen in the treatment of seborrheic keratosis. (PubMed, Dermatol Ther) - "There was a highly significant difference between the 2 treatment regimens as regard the percentage of change in surface area of the lesions, with higher change in the diclofenc 1% gel treated group (P = 0.001). No patients complain from any side effect from either treatment."

Journal

Evaluate the Ability of dOFM for BE Testing of Topically Applied Diclofenac Sodium Products in Healthy Subjects (clinicaltrials.gov) - P=N/A; N=26; Recruiting; Sponsor: Joanneum Research Forschungsgesellschaft mbH

Clinical • New trial

Penetration of topical diclofenac into synovial tissue and fluid of osteoarthritic knees: a multicenter, randomized, placebo-controlled, pharmacokinetic study. (PubMed, Ther Adv Musculoskelet Dis) - "TEAE rates were similar for diclofenac (55.2%) and placebo (58.8%); none were treatment related. Topical diclofenac diethylamine 2.32% w/w gel penetrated into the osteoarthritic knee after repeated application and remained detectable in synovial tissue and fluid at the end of the final 12 h dosing cycle."

Clinical • Journal • PK/PD data • Immunology • Musculoskeletal Pain • Orthopedics • Osteoarthritis • Pain • Rheumatology

Interventions to Prevent Nonmelanoma Skin Cancers in Recipients of a Solid Organ Transplant: Systematic Review of Randomized Controlled Trials. (PubMed, Transplantation) - "There is limited evidence for the efficacy and safety of specific treatments to prevent nonmelanoma skin cancers among solid organ transplant recipients."

Clinical • Journal • Review • Genetic Disorders • Pain • Solid Tumor

HORIZON THERAPEUTICS PUBLIC LTD CO MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS (form 10-Q) (Market Screener) - "PENNSAID 2%. Net sales decreased $16.4 million, or 32%, to $35.1 million during the three months ended June 30, 2020, from $51.5 million during the three months ended June 30, 2019....DUEXIS. Net sales decreased $2.3 million, or 8%, to $27.8 million during the three months ended June 30, 2020, from $30.1 million during the three months ended June 30, 2019....VIMOVO. Net sales decreased $8.4 million, or 57%, to $6.2 million during the three months ended June 30, 2020, from $14.6 million during the three months ended June 30, 2019."

Commercial • Sales • Osteoarthritis • Pain

Visualization of Epidermal Reservoir Formation from Topical Diclofenac Gels by Raman Spectroscopy. (PubMed, J Pain Res) - "The Raman images evidenced that the studied topical gels deliver diclofenac through the stratum corneum skin barrier and form a drug depot localized in the epidermis. The data are in line with earlier clinical findings that this depot acts like a true reservoir and enables sustained drug release."

Journal • Pain

Sustained acoustic medicine; sonophoresis for nonsteroidal anti-inflammatory drug delivery in arthritis. (PubMed, Ther Deliv) - "Topical diclofenac gel is limited in efficacy due to its limited penetration through the skin... Sonophoresis of the diclofenac gel for 4 h increases diclofenac delivery by 3.8× (p < 0.01), and penetration by 32% (p < 0.01). Sustained acoustic medicine can be used as a transdermal drug-delivery device for nonsteroidal anti-inflammatory drugs."

Journal • Immunology • Pain • Rheumatology