Drug-free gel containing ultra-deformable phospholipid vesicles (TDT 064) as topical therapy for the treatment of pain associated with osteoarthritis: a review of clinical efficacy and safety

Conaghan, Philip G.; Bijlsma, J. W. J.; Kneer, W.; Wise, Elspeth; Kvien, Tore K; Rother, M.

doi:10.1185/03007995.2013.860018

Cited by 10 publications

(8 citation statements)

References 48 publications

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“…This is understood to contribute to the pain and loss of joint function in osteoarthritis. The phospholipid vesicles within TDT 064 act as a biolubricant to supplement the phospholipid film (Conaghan et al, 2014).…”

Section: Discussionmentioning

confidence: 99%

“…These drug-free ultra-deformable Sequessome™ vesicles are the same as the active pharmaceutical ingredient-carrying Transfersome ® vesicles (IDEA AG, Germany), they are able to penetrate the skin, and were designed to provide targeted delivery of high drug concentrations into deeper subcutaneous tissues (Cevc & Blume, 1992;Cevc & Gebauer, 2003). TDT 064 has since demonstrated efficacy in reducing joint pain and osteoarthritis-associated pain (Conaghan et al, 2014;Conaghan, Dickson, Bolten, Cevc, & Rother, 2013).…”

Section: Introductionmentioning

confidence: 99%

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A randomised trial comparing the efficacy and safety of topical ketoprofen in Transfersome^® gel (IDEA-033) with oral ketoprofen and drug-free ultra-deformable Sequessome™ vesicles (TDT 064) for the treatment of muscle soreness following exercise

Seidel

Rother

Regenspurger

et al. 2015

Journal of Sports Sciences

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We compared the effectiveness of topical ketoprofen in Transfersome(®) gel (IDEA-033) with oral ketoprofen and drug-free Sequessome™ vesicles (FLEXISEQ(®) Sport; TDT 064) in reducing calf muscle soreness. One hundred and sixty eight healthy individuals with a pain score ≥ 3 (10-point scale) 12-16 h post-exercise (walking down stairs with an altitude of 300-400 m) were randomised to receive IDEA-033 plus oral placebo (two dose groups), oral ketoprofen plus TDT 064, or TDT 064 plus oral placebo. The primary endpoint was muscle soreness reduction from pre-dosing to Day 7. Higher pain scores were recorded with oral ketoprofen plus TDT 064 (mean ± s 462.4 ± 160.4) versus IDEA-033 plus oral placebo (434.7 ± 190.8; P = 0.2931) or TDT 064 plus oral placebo (376.2 ± 159.1; P = 0.0240) in the 7 days post-exercise. Recovery from muscle soreness was longer with oral ketoprofen plus TDT 064 (mean 91.0 ± 19.5 h) versus IDEA-033 plus placebo (mean 81.4 ± 22.9 h; P = 0.5964) or TDT 064 plus placebo (mean 78.9 ± 22.8 h; P = 0.0262). In conclusion, ultradeformable phospholipid vesicles ± ketoprofen did not retard recovery from muscle soreness. TDT 064 improves osteoarthritis-related pain and could be of interest as a treatment for joint pain during and post-exercise.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

A randomised trial comparing the efficacy and safety of topical ketoprofen in Transfersome^® gel (IDEA-033) with oral ketoprofen and drug-free ultra-deformable Sequessome™ vesicles (TDT 064) for the treatment of muscle soreness following exercise

Seidel

Rother

Regenspurger

et al. 2015

Journal of Sports Sciences

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“…Phospholipid administration demonstrates clinical benefit in treating osteoarthritis. Both liposomes [137,138] and micelles (Flexiseq®) [139] relieved osteoarthritis-related knee pain in clinical studies. Co-administration of phospholipids with HA prevented cartilage damage in a rabbit model of osteoarthritis [140].…”

Section: Therapeutic Strategiesmentioning

confidence: 99%

Active agents, biomaterials, and technologies to improve biolubrication and strengthen soft tissues

et al. 2018

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Normal functioning of articulating tissues is required for many physiological processes occurring across length scales from the molecular to whole organism. Lubricating biopolymers are present natively on tissue surfaces at various sites of biological articulation, including eyelid, mouth, and synovial joints. The range of operating conditions at these disparate interfaces yields a variety of tribological mechanisms through which compressive and shear forces are dissipated to protect tissues from material wear and fatigue. This review focuses on recent advances in active agents and biomaterials for therapeutic augmentation of friction, lubrication, and wear in disease and injured states. Various small-molecule, biological, and gene delivery therapies are described, as are tribosupplementation with naturally-occurring and synthetic biolubricants and polymer reinforcements. While reintroduction of a diseased tissue's native lubricant received significant attention in the past, recent discoveries and pre-clinical research are capitalizing on concurrent advances in the molecular sciences and bioengineering fields, with an understanding of the underlying tissue structure and physiology, to afford a desired, and potentially patient-specific, tissue mechanical response for restoration of normal function. Small and large molecule drugs targeting recently elucidated pathways as well as synthetic and hybrid natural/synthetic biomaterials for restoring a desired tissue mechanical response are being investigated for treatment of, for example, keratoconjunctivitis sicca, xeroderma, and osteoarthritis.

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“…TDT 064 is a topical agent that was recently reported on for its efficacy for treatment of osteoarthritis. 14 This was in spite of the fact that the specific mechanism of action in pain relief of TDT 064 has not been completely clarified. TDT 064 is a gel containing hydrophilic, nano-scale lipid vesicles with a phospholipid bilayer.…”

Section: Introductionmentioning

confidence: 99%

A Randomized Placebo-Controlled Trial of Efficacy and Safety: Drug-Free Gel Containing Ultra-Deformable Phospholipid Vesicles (TDT 064) in Osteoarthritic Knees

Yuenyongviwat

Iamthanaporn

Tuntarattanapong

et al. 2021

Clin Med�Insights�Arthritis�Musculoskelet Disord

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Background: There are a number of topical agents that are used for treatment of knee osteoarthritis. Drug-free gels, containing ultra-deformable phospholipid vesicles (TDT 064) are one such topical therapy, which have been stated to act as a bio lubricant. However, the evidence of TDT 064 in treatment of knee osteoarthritis is limited. Hence, the aim of this study was to evaluate the efficacy of pain control as a primary outcome and safety of TDT 064 compared with a topical placebo. Methods: Sixty-four patients with primary osteoarthritis, with radiographic showing Kellgren and Lawrence classification grade II to III, were randomized into 2 groups. In the first group of 32 patients TDT 064 was used as topical agent, whilst in the second group of 32 patients a placebo identical in appearance was used instead. The verbal numerical rating scale (VNRS) was used for recording pain levels, Self-reported Knee Injury and Osteoarthritis Outcome Scores (KOOS) as well as amounts of rescue medication were also recorded. The data were recorded at the start of the study, and then at follow-up appointments of 14 days, 6 weeks, and 3 months. Results: The mean VNRS for pain in both groups were significantly improved, when compared to the start of treatment ( P < .0001); however, there were no differences between groups at any follow up visit. KOOS in all subscales were not significantly different between both groups at baseline and at the end of treatment. However, the average amount of NSAIDs in the TDT 064 group was 26.39 ± 22.11 tabs, which was significantly lower than the control group; which used an average 37.03 ± 19.22 tabs in 3 months ( P = .047). Conclusions: There were no differences in the VNRS for pain and KOOS scores between the active and placebo groups. Although, TDT 064 could decrease usage of rescue medication the difference with use of a placebo was minimal. Further, larger trials would also be beneficial to demonstrate any differences between TDT 064 and a placebo. Trial Registration: TCTR, TCTR 20190302001. Registered 1 March, 2019: http://www.clinicaltrials.in.th

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Drug-free gel containing ultra-deformable phospholipid vesicles (TDT 064) as topical therapy for the treatment of pain associated with osteoarthritis: a review of clinical efficacy and safety

Abstract: Evidence from clinical studies supports the use of TDT 064 as a drug-free topical treatment for patients with OA. Further experience with TDT 064, particularly among patients with comorbidities or NSAID contraindications, will provide more information on its potential use.

Cited by 10 publications

References 48 publications

A randomised trial comparing the efficacy and safety of topical ketoprofen in Transfersome^® gel (IDEA-033) with oral ketoprofen and drug-free ultra-deformable Sequessome™ vesicles (TDT 064) for the treatment of muscle soreness following exercise

A randomised trial comparing the efficacy and safety of topical ketoprofen in Transfersome^® gel (IDEA-033) with oral ketoprofen and drug-free ultra-deformable Sequessome™ vesicles (TDT 064) for the treatment of muscle soreness following exercise

Active agents, biomaterials, and technologies to improve biolubrication and strengthen soft tissues

A Randomized Placebo-Controlled Trial of Efficacy and Safety: Drug-Free Gel Containing Ultra-Deformable Phospholipid Vesicles (TDT 064) in Osteoarthritic Knees

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Drug-free gel containing ultra-deformable phospholipid vesicles (TDT 064) as topical therapy for the treatment of pain associated with osteoarthritis: a review of clinical efficacy and safety

Abstract: Evidence from clinical studies supports the use of TDT 064 as a drug-free topical treatment for patients with OA. Further experience with TDT 064, particularly among patients with comorbidities or NSAID contraindications, will provide more information on its potential use.

Cited by 10 publications

References 48 publications

A randomised trial comparing the efficacy and safety of topical ketoprofen in Transfersome® gel (IDEA-033) with oral ketoprofen and drug-free ultra-deformable Sequessome™ vesicles (TDT 064) for the treatment of muscle soreness following exercise

A randomised trial comparing the efficacy and safety of topical ketoprofen in Transfersome® gel (IDEA-033) with oral ketoprofen and drug-free ultra-deformable Sequessome™ vesicles (TDT 064) for the treatment of muscle soreness following exercise

Active agents, biomaterials, and technologies to improve biolubrication and strengthen soft tissues

A Randomized Placebo-Controlled Trial of Efficacy and Safety: Drug-Free Gel Containing Ultra-Deformable Phospholipid Vesicles (TDT 064) in Osteoarthritic Knees

Contact Info

Product

Resources

About

A randomised trial comparing the efficacy and safety of topical ketoprofen in Transfersome^® gel (IDEA-033) with oral ketoprofen and drug-free ultra-deformable Sequessome™ vesicles (TDT 064) for the treatment of muscle soreness following exercise

A randomised trial comparing the efficacy and safety of topical ketoprofen in Transfersome^® gel (IDEA-033) with oral ketoprofen and drug-free ultra-deformable Sequessome™ vesicles (TDT 064) for the treatment of muscle soreness following exercise