Flector (diclofenac epolamine) / IBSA Institute Biochemical SA - LARVOL DELTA

The Potential Benefits of a Novel Food Supplement Based on Cannabis Sativa, Boswellia, and Fish Oil for Pain and Inflammation in Physical Activity: Unraveling the Role of Orexin-A Modulation. (PubMed, Sports (Basel)) - "Flector Softgel FS Integratore may be effective in reducing joint pain and systemic inflammation while supporting metabolic health in active adults. These effects may involve indirect modulation of orexin-A, though the exact mechanisms remain to be clarified. Despite the promising results, conclusions regarding efficacy in comparison with NSAIDs should be approached with caution in the absence of a pharmacological control group. Further studies with larger samples and a longer duration are needed."

Journal • Inflammation • Inflammatory Arthritis • Metabolic Disorders • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Pain • CXCL8 • IFNG • IL10 • IL6 • TNFA

Yaral Pharma Launches Diclofenac Epolamine Topical System 1.3% (Businesswire) - "Yaral Pharma Inc...announced the launch of diclofenac epolamine topical system 1.3%, the authorized generic of IBSA Pharma’s Flector® (diclofenac epolamine) topical system. Diclofenac epolamine topical system 1.3% is a prescription nonsteroidal anti-inflammatory (NSAID) medicated patch indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions."

Generic launch • Back Pain • CNS Disorders • Pain

Nonopioid drugs for pain. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Immunology • Neuralgia • Osteoarthritis • Pain • Rheumatology

Safety and Efficacy of the FLECTOR (Diclofenac Epolamine) Topical System in Children with Minor Soft Tissue Injuries: A Phase IV Non-randomized Clinical Trial. (PubMed, Clin Drug Investig) - P4 | "The FLECTOR topical system safely and effectively provided pain relief for minor soft tissue injuries in the pediatric population, with minimal systemic nonsteroidal anti-inflammatory drug exposure and low potential risk of local or systemic adverse events."

Clinical • Journal • P4 data • Pain • Pediatrics

IBSA Reacquires Commercial Rights to the Flector Brand in the US (PRNewswire) - "IBSA Pharma Inc. has taken back marketing and distribution rights for Flector (diclofenac epolamine) topical system 1.3% from Pfizer as of January 1st, 2021. With the return of the commercial rights of Flector, a product that IBSA has developed, IBSA now offers two prescription topical drugs to treat acute pain due to minor strains, sprains, and contusions."

Commercial • Back Pain • Musculoskeletal Pain • Pain

Licart Now Available to Treat Acute Pain Due to Minor Strains, Sprains, and Contusions (PRNewswire) - "IBSA Pharma Inc....announced that it has launched Licart (diclofenac epolamine) topical system 1.3% in the US market for the treatment of acute pain due to minor strains, sprains, and contusions....Licart is the first and only once-a-day topical nonsteroidal anti-inflammatory drug (NSAID) therapy approved by the FDA....'Licart represents an evolution in the topical treatment of acute pain. While topical NSAID therapy has been available for decades, this is the first FDA-approved topical system with once-a-day dosing.'"

Launch US • Back Pain • Musculoskeletal Pain • Pain

A sport cream (Harpago-Boswellia-ginger-escin) for localized neck/shoulder pain. (PubMed, Minerva Med) - "Finally, subjects receiving sport cream + SM reported a more remarkable decrease in skin temperature in the affected area associated to an improvement in clinical symptoms."

Journal • Musculoskeletal Pain • Pain

Drugs for osteoarthritis. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Immunology • Pain • Rheumatology

Evaluation of Bioavailability of Diclofenac Dermal Products (clinicaltrials.gov) - P1; N=12; Completed; Sponsor: University of Maryland, Baltimore; Active, not recruiting ➔ Completed

Trial completion

Topical NSAID formulations (Pain Med) - "In the United States, several topical NSAID products are approved to treat painful conditions including diclofenac sodium 1% gel (Voltaren Gel(®) ; Endo Pharmaceuticals), diclofenac sodium topical solution 1.5% w/w in 45.5% dimethyl sulfoxide (PENNSAID(®) ; Mallinckrodt, Inc.), and diclofenac epolamine 1.3% (Flector Patch(®) ; Alpharma Pharmaceuticals LLC, a subsidiary of Pfizer, Inc.)....Topical NSAIDs have been shown to be beneficial from both a therapeutics and adverse effect perspective, and are increasingly recommended in treatment guidelines."

Review • Pain

Safety and Efficacy of Generic Diclofenac Epolamine Acute Pain Due to Minor Ankle Sprain (clinicaltrials.gov) - P3; N=658; Completed; Sponsor: Actavis Inc.

New P3 trial • Biosimilar • Pain

Rationale and evidence for the incorporation of heparin to the diclofenac epolamine medicated plaster. (PubMed, Curr Med Res Opin) - "The benefit/risk assessment of DHEP Plus 180 mg medicated plaster is favorable, with a safety profile equal to placebo and improved efficacy over the reference marketed DHEP medicated plaster."

Journal

Systematic review of topical diclofenac for the treatment of acute and chronic musculoskeletal pain. (PubMed, Curr Med Res Opin) - "Compared to placebo, number needed to treat (NNT) for different formulations were as follows: diclofenac flector plaster, 4.7 (95%CI 3.7-6.5); diclofenac plaster with heparin, 7.4 (95%CI 4.6-19); and diclofenac emulgel, 1.8 (95%CI 1.5-2.1).4.7% (65/1373) participants reported a systemic AE; 4.1% (78/1919) reported a local AE; and 1.3% (14/1063) withdrew due to an AE...Formulation does play a part in effectiveness, and studies are needed to investigate this further. Studies of chronic pain outside of osteoarthritis would also be helpful."

Journal • Review

SCOUT Reflector for Tagging Lymph Nodes for Targeted Removal in Patients With Breast Cancer (clinicaltrials.gov) - P=N/A; N=25; Not yet recruiting; Sponsor: Jonsson Comprehensive Cancer Center; Initiation date: Jan 2019 ➔ Jun 2019

Clinical • Trial initiation date

The Effect of Reflective Breathing Therapy Compared With Conventional Breathing Therapy in Patients With Chronic Obstructive Pulmonary Disease (COPD) III-IV; part2 (clinicaltrials.gov) - P=N/A; N=44; Recruiting; Sponsor: Klinikum Berchtesgadener Land der Schön-Kliniken; Trial completion date: Dec 2018 ➔ Jul 2019; Trial primary completion date: Dec 2018 ➔ May 2019

Clinical • Trial completion date • Trial primary completion date