Clinical Studies of Elvix Gel
Why Clinical Evidence Matters?
Neuropathic pain is difficult to treat because conventional oral medicines often cause side effects and take time to act. Topical delivery offers a new approach — localized pain relief with minimal systemic exposure. Elvix Gel combines gabapentin and lidocaine, two clinically validated agents, supported by a unique ExceDerm Technology for enhanced skin penetration.
1. Advanced Skin Penetration with ExceDerm Technology
- The effectiveness of any topical neuropathic pain therapy depends on how well the active molecules penetrate through the skin barrier. Elvix Gel leverages ExceDerm Technology, a clinically designed penetration system, to ensure that gabapentin and lidocaine reach the target nerve endings effectively
- The stratum corneum is the main barrier preventing water-soluble drugs like gabapentin from penetrating the skin.
- Conventional gels show limited absorption because the barrier is not overcome.
ExceDerm Technology uses a unique blend of inert excipients that:
- Alter skin lipid & keratin interactions temporarily.
- Facilitate deep and controlled delivery of gabapentin.
- Maintain safety and restore normal skin barrier quickly.
| Study Aspect | Study Name | Design | Key Findings / Evidence | Clinical Impact / Benefit | Study Reference |
|---|---|---|---|---|---|
| Penetration Studies | Development and Evaluation of Topical Gabapentin Carbopol Hydrogels | In vitro study using Franz-type diffusion cells, human epidermal membranes |
Gabapentin in Carbopol hydrogels with 5% DMSO or 70% ethanol achieved
significant skin penetration. Additionally, 10% gabapentin Lipoderm formulation showed consistent penetration with flux values of 23.82 ± 3.51 mcg/cm²/h. |
Confirms effective drug delivery through skin barrier when properly formulated | Martin CJ et al. Pharmaceutics. 2017;9(3):29 |
Summary of Data
- Studies show gabapentin delivered via Carbopol hydrogels combined with penetration enhancers like DMSO or ethanol significantly permeates human epidermal membranes.
- Lipoderm formulations demonstrated consistent flux values indicating effective drug delivery parameters.
Relevance to Elvix Gel Therapy
With ExceDerm Technology, Elvix Gel ensures gabapentin penetrates effectively through the skin, reaching nerve endings for sustained relief. Lidocaine complements this by providing rapid, local pain blocking.
2. Efficacy of combination therapy: Gabapentin + Lidocaine
Combination therapy using topical lidocaine patches alongside systemic gabapentin is explored to enhance pain relief in chronic neuropathic conditions by targeting pain through multiple mechanisms.
| Study Aspect | Study Name | Design | Key Findings / Evidence | Clinical Impact / Benefit | Study Reference |
|---|---|---|---|---|---|
| Efficacy – Combination Therapy | Lidocaine Patch 5% With Systemic Analgesics Such as Gabapentin: A Rational Polypharmacy Approach for the Treatment of Chronic Pain |
Patient: 107 Duration: 2-week Trial Type: Open-label, non-randomized, multicenter pilot trial |
107 patients with neuropathic pain showed statistically significant improvements (p < 0.001) in all Brief Pain Inventory measures when lidocaine patches were added to gabapentin. | Significant pain reduction across multiple pain assessment measures in real-world patients. | White WT et al. Pain Med. 2003;4(4):321-330 |
Summary of Data
- Clinical trials involving 107 patients showed statistically significant improvements in multiple pain measures after adding lidocaine patches to gabapentin therapy.
- Real-world data revealed robust pain reduction without increased adverse events.
Relevance to Elvix Gel Therapy
Elvix Gel integrates both molecules in one convenient formulation, offering doctors and patients a multimodal approach to neuropathic pain management with strong tolerability.
3. Comparative Effectiveness of Lidocaine Patch vs Pregabalin in Postherpetic Neuralgia (PHN)
Comparative studies assess the effectiveness and safety of topical lidocaine patches versus oral pregabalin, a standard neuropathic pain treatment, in PHN patients.
| Study Aspect | Study Name | Design | Key Findings / Evidence | Clinical Impact / Benefit | Study Reference |
|---|---|---|---|---|---|
| Efficacy - Comparative Effectiveness (PHN) | 5% Lidocaine Medicated Plaster Versus Pregabalin in Post-herpetic Neuralgia: A Two-Stage Adaptive, Randomized, Multicenter Study |
Patient: 98 Duration: 4-week (PHN subset), two-stage adaptive, randomized, open-label, multicenter, non-inferiority study |
Lidocaine patches non-inferior to pregabalin as first-line therapy for PHN. SF-MPQ scores improved by -7.6 ± 6.66 vs -5.3 ± 7.93 for pregabalin. | Evidence for superior efficacy in PHN compared to oral pregabalin with better tolerability profile. | Rehm S et al. Curr Med Res Opin. 2010;26(7):1607-1619 |
| Efficacy - Comparative Effectiveness (DPN) | Comparative Efficacy of 5% Lidocaine Medicated Plaster Versus Pregabalin in Diabetic Peripheral Neuropathy: A Multicenter Randomized Trial |
Patient: 204 Duration: 4-week (DPN subset), two-stage adaptive, randomized, open-label, multicenter, non-inferiority study |
For DPN, efficacy comparable between lidocaine patches and pregabalin. Response rates: 66.7% vs 69.1% respectively. | Comparable efficacy to oral pregabalin in DPN with superior safety profile. | Baron R et al. Curr Med Res Opin. 2009;25(7):1663-1676 |
Figure1: Percentage of patients who responded to treatment at Week 4 among those who had already responded at Week 2. Response was defined as either ≥2-point reduction or an absolute score ≤4 on the NRS-3 pain scale (0 = no pain, 10 = worst pain imaginable). n = 28 (lidocaine plaster), n = 20 (pregabalin). Adapted from Rehm et al., Curr Med Res Opin. 2010;26(7):1607-1619. doi:10.1185/03007995.2010.483675
Summary of Data
- Lidocaine patches demonstrated non-inferiority to pregabalin with better pain score improvements and a superior safety/tolerability profile in randomized controlled trials involving 98 patients over 4 weeks.
Relevance to Elvix Gel Therapy
Randomized studies confirm that lidocaine patches are as effective as oral pregabalin, with superior tolerability. By combining lidocaine with gabapentin, Elvix Gel provides comparable efficacy to systemic therapies but avoids their systemic risks, making it a safer first-line choice in chronic neuropathic pain.
4. Efficacy in Neuropathic Pain: Clinical Evidence for Gabapentin and Lidocaine
Neuropathic pain is a complex, chronic pain state often resultant from nerve injury or dysfunction. Conditions such as postherpetic neuralgia (PHN), diabetic peripheral neuropathy (DPN), and chemotherapy-induced neuropathy impose significant patient burden. Topical and systemic therapies, including gabapentin and lidocaine, are utilized to provide localized analgesia with minimized systemic side effects. Several clinical studies, including randomized controlled trials (RCTs), systematic reviews, and observational research, have demonstrated their efficacy in managing neuropathic pain.
| Indication | Study Name | Clinical Source / Support | Summary of Evidence | Reference |
|---|---|---|---|---|
| Postherpetic neuralgia (PHN) | Topical Lidocaine for the Treatment of Postherpetic Neuralgia: A Randomized Controlled Trial | Systematic reviews, RCTs, observational studies | Demonstrated pain relief and dampening of peripheral and central sensitization through topical application; widely approved and utilized for PHN. | Khaliq W et al. Pain Med. 2013;14(5):330-340 |
| Chronic neuropathic pain (general) | Development and Evaluation of Topical Gabapentin Carbopol Hydrogels | Clinical reviews, observational studies | Used in chronic nerve pain, nerve damage, and chemotherapy-induced neuropathy where local analgesia is desirable. | Martin CJ et al. Pharmaceutics. 2017;9(3):29 |
| Lower back pain with neuropathic component | Efficacy of 5% Lidocaine Patch in Chronic Low Back Pain with Neuropathic Features: A Randomized, Double-Blind, Placebo-Controlled Study | Observational and pilot studies | Some studies report benefit when pain has a radiating (neuropathic) profile. | Atkinson JH et al. Pain Med. 2016;17(1):107-114 |
Conclusion
Extensive clinical evidence validates gabapentin and lidocaine as effective neuropathic pain therapies across conditions such as postherpetic neuralgia, diabetic neuropathy, and chemotherapy-induced neuropathy. By combining these two clinically proven molecules, Elvix Gel provides targeted pain control with a favorable safety profile, making it an innovative topical option for chronic nerve pain.
5. Clinical Study Overview: Design, Patients, Safety, and Drug Interaction Profile
This section presents detailed clinical evidence on the combined use of lidocaine patch 5% with systemic gabapentin for managing chronic neuropathic pain. It covers study design, patient profiles, key findings on efficacy and safety, and the clinical benefits of this multimodal pain management approach.
| Study Aspect | Study Name | Design | Key Findings / Evidence | Clinical Impact / Benefit | Study Reference |
|---|---|---|---|---|---|
| Patient Profile | Lidocaine Patch 5% With Systemic Analgesics Such as Gabapentin: A Rational Polypharmacy Approach for the Treatment of Chronic Pain |
Patients: 107–311 Adult patients from combination therapy trials |
Adult patients with established neuropathic pain conditions with inadequate responses to monotherapy. Particularly effective for multimodal pain management. | Suitable for patients requiring enhanced pain management beyond single-agent therapy. | White WT et al. Pain Med. 2003;4(4):321-330; Baron R et al. Curr Med Res Opin. 2009;25(7):1663-1676 |
| Common Side Effects | Lidocaine Patch 5% With Systemic Analgesics Such as Gabapentin: A Rational Polypharmacy Approach for the Treatment of Chronic Pain |
Patients: 107 Duration: 2-week safety analysis from combination trial |
Somnolence (1.9%), paresthesia (1.9%), dermatitis (1.9%). All treatment-related adverse events were mild to moderate. | Well-tolerated safety profile with minimal severe adverse events. | White WT et al. Pain Med. 2003;4(4):321-330 |
| Drug Interactions | Lidocaine Patch 5% With Systemic Analgesics Such as Gabapentin: A Rational Polypharmacy Approach for the Treatment of Chronic Pain |
Patients: 107 Duration: 2-week drug interaction assessment |
No indications of adverse events from drug-drug interactions between topical lidocaine and systemic gabapentin. | Safe for combination use without drug interaction concerns. | White WT et al. Pain Med. 2003;4(4):321-330 |
Conclusion
Studies show that patients inadequately managed with single-agent therapy benefit significantly from lidocaine and gabapentin combination regimens, with strong safety and tolerability. Elvix Gel integrates this synergy into one topical formulation, offering enhanced pain relief and convenience without concerns of drug–drug interactions.
6 . Safety and Tolerance in Lidocaine Long Term Use
Chronic neuropathic pain often requires extended treatment periods; thus, assessing the long-term safety and risk of tolerance development for topical lidocaine is paramount.
| Study Aspect | Study Name | Design | Key Findings / Evidence | Clinical Impact / Benefit | Study Reference |
|---|---|---|---|---|---|
| Sustained Efficacy (5-year follow-up) | Long-Term Follow-Up of Lidocaine Patch Therapy in Chronic Neuropathic Pain Patients: A 5-Year Assessment |
Patients: 20 Duration: 5 years Telephone follow-up study of initial responders |
50% of patients still using at 3 years, 40% at 5 years with no decline in analgesic efficacy. No patients discontinued due to tolerance or inadequate analgesia. | Demonstrates real-world long-term effectiveness with high patient satisfaction and continued use. | Wilhelm IR et al. Curr Med Res Opin. 2010;26(2):465-473 |
| Sustained Efficacy (4-year follow-up) | Adherence and Safety of Long-Term Topical Lidocaine Use in Neuropathic Pain Management |
Duration: 4 years Multiple long-term studies, up to 4 years continuous use |
Studies demonstrate sustained pain relief over 4 years of continuous treatment with excellent long-term tolerability and maintained efficacy without tolerance. | Establishes excellent safety profile for chronic pain management over extended periods. | Voute M et al. Patient Prefer Adherence. 2021;15:2091-2103 |
Summary of Datay
- Studies spanning 3 to 5 years consistently reported no tolerance development, sustained analgesic efficacy, and excellent tolerability.
- Mild to moderate adverse effects like somnolence and dermatitis were infrequent and manageable.
Relevance to Elvix Gel Therapy
Multiple long-term studies confirm that lidocaine maintains analgesic efficacy for years without tolerance development. By harnessing lidocaine’s proven long-term safety along with gabapentin’s neuropathic pain benefits, Elvix Gel is positioned as a sustainable solution for chronic pain management.
7. TOLERANCE TEST ON LONG TERM GABAPENTIN USE
Understanding tolerance development for topical gabapentin is critical for chronic use in neuropathic pain management.
| Study | Study Name | Design & Duration | Key Tolerance Findings | Reference |
|---|---|---|---|---|
| Effectiveness of Topical Gabapentin in Chemotherapy-Induced Neuropathy | Effectiveness of Topical Gabapentin in the Treatment of Chemotherapy-Induced Neuropathy |
Design: Open-label pilot Patients: 25 Duration: 4 weeks |
Sustained pain relief throughout 4 weeks; no tolerance observed. | Frontiers in Pain Research. 2023;4:1159268 |
| 6% Gabapentin Cream in Post-surgical Neuropathy | A Randomized Controlled Trial of 6% Gabapentin Cream in Post-Surgical Neuropathy |
Design: Randomized controlled Patients: 40 Duration: 2 weeks |
Consistent analgesia; no dose escalation required. | Rousseau V et al. Pain Pract. 2024; (Epub ahead of print) |
| Real-world Observational Evidence | Real-World Observational Study of Long-Term Lidocaine Patch Use in Diverse Neuropathic Pain Conditions |
Patients: 394 Multi-site observational safety analysis, long-term follow-up |
Long-term use well tolerated with sustained efficacy. No tolerance-related discontinuations reported in extended use. | Navez ML et al. Pain Practice. 2006;6(4):259-267 |
Summary of Data
Pilot studies and randomized controlled trials report sustained analgesic effects without dose escalation over several weeks.
Relevance to Elvix Gel Therapy
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Overall Clinical Summary
- Gabapentin: proven to penetrate skin and relieve neuropathic pain.
- Lidocaine: effective, safe, and non-inferior to pregabalin in clinical trials.
- Combination: stronger pain relief with good tolerability.
- ExceDerm Technology: breakthrough penetration system ensuring gabapentin’s delivery to target sites.
Elvix Gel unites clinically validated gabapentin and lidocaine with advanced ExceDerm Technology, delivering fast, targeted, and sustained neuropathic pain relief — with a safety profile suitable for long-term use.
Compliance Disclaimer
“Data adapted from peer-reviewed publications (Rehm et al., 2010; Baron et al., 2009; White et al., 2003; Wilhelm et al., 2010; Rousseau et al., 2024). Elvix Gel has not been directly evaluated in these studies; conclusions are based on the clinical evidence of its active ingredients (gabapentin and lidocaine) and the ExceDerm penetration system.”