Pennsaid (diclofenac sodium topical solution 1.5%) / Miravo - LARVOL DELTA

Study to determine the efficacy and onset of Bonipar, a topical analgesic for the management of acute and chronic musculoskeletal pain. (PubMed, Complement Ther Clin Pract) - "The topical analgesic Bonipar demonstrates a comparable onset of action, with efficacy non-inferior to diclofenac in the management of musculoskeletal pain, while showing fewer adverse effects compared to diclofenac. These findings highlight the potential of Bonipar as a valuable alternative for the treatment of localized pain."

Journal • Musculoskeletal Diseases • Musculoskeletal Pain • Pain

Topical Delivery Systems Effectively Transport Analgesics to Areas of Localized Pain via Direct Diffusion. (PubMed, Pharmaceutics) - "An investigational TDS containing 108 mg lidocaine (SP-103, 5.4% lidocaine), a commercially available TDS containing 36 mg lidocaine (ZTlido, 1.8% lidocaine), and a topical pain relief gel (Pennsaid, 2% diclofenac) were tested...The data showed a clear contribution of diffusive transport to lidocaine concentration, with SP-103 5.4% resulting in a significantly higher lidocaine concentration in muscle tissue than commercially available ZTlido (p = 0.008). These results indicate that SP-103 5.4% is highly effective in delivering lidocaine into muscle tissue in areas of localized pain for the treatment of musculoskeletal pain disorders (e.g., lower back pain)."

Journal • Back Pain • Musculoskeletal Diseases • Musculoskeletal Pain • Pain

Bonipar for Acute and Chronic Musculoskeletal Pain (clinicaltrials.gov) - P2 | N=223 | Completed | Sponsor: Winston Parris, MD | Recruiting ➔ Completed | N=168 ➔ 223 | Trial completion date: Mar 2023 ➔ Sep 2022 | Trial primary completion date: Mar 2023 ➔ Sep 2022

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Musculoskeletal Diseases • Musculoskeletal Pain • Pain

Briori Biotech (BIO 2022) - "The company's founders represent the original Merck team that brought Vioxx to the market and were also instrumental in bringing Voltaren and Pennsaid to the market...Vioxx is the most powerful NSAID and as a topical formulation exhibits more than a 660-fold improved therapeutic index compared to oral dosages. BriOri is currently seeking investors and licensees."

Immunology • Osteoarthritis • Pain • Rheumatology

Miravo Healthcare Announces First Quarter 2022 Results (Businesswire) - "Nuvo Pharmaceuticals Inc...d/b/a Miravo Healthcare (Miravo or the Company)...today announced its financial and operational results for the three months ended March 31, 2022....Revenue attributable to the Commercial Business segment increased during the three months ended March 31, 2022 due to a $2.2 million increase in sales of the Company’s promoted products (Blexten, Cambia, Suvexx and NeoVisc®) and a $0.2 million increase in sales of the Company’s mature products....The Production and Service Business segment revenue decreased during the three months ended March 31, 2022, primarily due to a decrease in Pennsaid 2% product sales, slightly offset by an increase in sales of Pennsaid and Resultz."

Commercial • CNS Disorders • Osteoarthritis • Pain

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

Journal • Immunology • Neuralgia • Osteoarthritis • Pain • Rheumatology

Bonipar for Acute and Chronic Musculoskeletal Pain (clinicaltrials.gov) - P2; N=168; Recruiting; Sponsor: Winston Parris, MD; Phase classification: P1 ➔ P2

Clinical • Phase classification • Musculoskeletal Diseases • Musculoskeletal Pain • Pain

Bonipar for Acute and Chronic Musculoskeletal Pain (clinicaltrials.gov) - P1; N=168; Recruiting; Sponsor: Winston Parris, MD; Trial completion date: Dec 2022 ➔ Mar 2023; Trial primary completion date: Dec 2022 ➔ Mar 2023; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Trial completion date • Trial primary completion date • Musculoskeletal Diseases • Musculoskeletal Pain • Pain

A study to investigate drug concentrations in the skin using a special dermal sampling technique (clinicaltrialsregister.eu) - P1/2; N=26; Ongoing; Sponsor: HEALTH – Institute for Biomedicine and Health Sciences, JOANNEUM RESEARCH Forschungsgesellschaft mbH

Clinical • New P1/2 trial

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

Journal • Immunology • Pain • Rheumatology

Topical diclofenac-loaded liposomes ameliorate laser-induced choroidal neovascularization in mice and non-human primates. (PubMed) - "In conclusion, diclofenac-loaded liposome eye drops enhance penetration to the RPE-choroid, and reduce the CNV formation. These results suggest that a drug-loaded liposome is a useful tool for drug delivery into the posterior segment of the eye."

Journal • Age-related Macular Degeneration • Biosimilar • Complement-mediated Rare Disorders • Gene Therapies

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

Bilateral corneal melting associated with topical diclofenac use following cataract surgery in a patient with Sjgren's syndrome (ESCRS 2018) - "...Oral doxycycline 200mg and prednisolone 30 mg daily were given... Topical diclofenac can cause acute corneal melting and loss of vision after cataract surgery, especially in patients with Sjgren's syndrome. Cataract surgery should not be performed on both eyes with Sjgren's syndrome within a very short period of time. "

Clinical • Dry Eye Disease • Keratitis

Efficacy and safety of diclofenac sodium 2% topical solution for osteoarthritis of the knee: a randomized, double-blind, vehicle-controlled, 4 week study. (PubMed) - "Administration of diclofenac sodium 2% topical solution BID resulted in significantly greater improvement in pain reduction in patients with OA of the knee versus vehicle control and was generally well tolerated."

Journal • Biosimilar • Immunology • Inflammation • Osteoarthritis • Pain

Nuvo Research announces positive top-line results for Pennsaid viscous solution phase 2 trial (PRNewswire) - P2, N=259; The study met its primary endpoint of reducing osteoarthritis (OA) pain greater vs. PBO; The most common adverse event in both groups was application site dryness (21.5% and 21.7%); Nuvo looks forward to receiving detailed results from this study in future & working with Covidien to obtain FDA approval for Pennsaid viscous solution previously referred to as Pennsaid gel

P2 data • Pain

The comparison of analgesic effects of various administration methods of diclofenac sodium, transdermal, oral and intramuscular, in early postoperative period in laparoscopic cholecystectomy operations (Pak J Med Sci) - P=NA, N=90; "In patients undergoing ambulatory laparoscopic cholecystectomy, a noninvasive application transdermal diclofenac sodium is as effective as intramuscular diclofenac sodium and can be preferred in postoperative pain treatment."

Clinical data • Pain

Orange Book: Approved drug products with therapeutic equivalence evaluations: Newly added patent (FDA) - Newly added patent in Orange Book for Pennsaid.

Patent • Pain

Nuvo Research provides Pennsaid update (PRNewswire) - Pennsaid surpassed Voltaren gel in the number of U.S. prescriptions filled; Pennsaid U.S. gross sales are now running at an annualized rate of approximately USD 124M; Pennsaid U.S. prescriptions increase 98 percent quarter-over-quarter

Sales update • Pain

Topical bioavailability of diclofenac from locally-acting, dermatological formulations. (PubMed, Int J Pharm) - "...The objective of this work was to evaluate in vitro skin penetration and stratum corneum tape-stripping in vivo as tools with which to measure topical diclofenac bioavailability from three approved and commercialized products (two gels and one solution)...Evidence is therefore presented to support an in vivo - in vitro correlation between methods to assess topical drug bioavailability. The potential value of the stratum corneum tape-stripping technique to quantify drug delivery into (epi)dermal and subcutaneous tissue beneath the barrier is demonstrated."

Journal • Biosimilar

Nuvo Research announces 2014 fourth quarter & year-end results (PRNewswire) - "Revenue, consisting of product sales, royalties, license fee revenue and research and other contract revenue for the three months ended December 31, 2014 was $3.4 million compared to $3.7 million for the three months ended December 31, 2013. The decrease in revenue was attributable to lower royalty revenue primarily from Pennsaid and Pennsaid 2% net sales in the U.S. market."

Commercial • Pain

PHOTOSTABILITY AND EX-VIVO PERMEATION STUDIES ON DICLOFENAC IN TOPICAL NIOSOMAL FORMULATIONS. (PubMed) - "Moreover, niosomal gel also influenced the permeation capability of DC by enhancing the transdermal delivery of the drug. The cumulative dose permeated of DC from niosomal gel was about three times that obtained with the commercial gel."

Journal • Biosimilar

The effect of topical diclofenac 3% and calcitriol 3 μg/g on superficial basal cell carcinoma (sBCC) and nodular basal cell carcinoma (nBCC): A phase II, randomized controlled trial. (PubMed) - J Am Acad Dermatol - "Our results suggest that topical diclofenac is a promising new treatment for sBCC. Its mode of action differs from available noninvasive therapies, and thus has an additive value."

Journal • Biosimilar • Non-Hodgkin’s Lymphoma • Oncology

When "Effective" Prevention Agents Fail to Elicit Anticipated Effects: Challenges in Trial Design. (PubMed) - Cancer Prev Res (Phila) - "Although the results were interpreted as null, they could also be considered as an insufficient test of efficacy; in any case, they are certainly also informative regarding the many challenges of clinical chemoprevention trials. Here we summarize some of these points to highlight the challenges and better inform future clinical research projects and designs."

Journal • Biosimilar • Oncology

A Comparative of Ginger Extract in Nanostructure Lipid Carrier (NLC) and 1% Diclofenac Gel for Treatment of Knee Osteoarthritis (OA). (PubMed, J Med Assoc Thai) - "...The response rate for at least a 50% reduction in pain was significantly greater following Ginger extract in NLC treatment compared to topical diclofenac [40/59 (67.7%) vs. 27/59 (45.7%) p<0.05]...Ginger extract in NLC relieves pain, improves function, and improves the Patient Global Assessment in OA knee during a 12-week treatment."

Journal • Biosimilar • Immunology • Osteoarthritis • Pain

Topical diclofenac therapy for osteoarthritis: a meta-analysis of randomized controlled trials. (PubMed) - "It may also have a potential effect in function improvement, which needs further studies to be explored. Although, some adverse effects were observed in the application of topical diclofenac, none of them was serious."

Journal • Biosimilar • Dermatitis • Immunology • Inflammation • Osteoarthritis • Pain