Tarlige (mirogabalin) / Daiichi Sankyo, Menarini - LARVOL DELTA

A case of dementia with Lewy bodies with psychosis induced by low-dose gabapentinoids. (PubMed, BMC Psychiatry) - "Although pregabalin-induced psychosis has been reported at higher doses (300-450 mg daily), it has not been reported at doses as low as those used in this patient. Gabapentinoids may cause psychosis in patients with dementia with Lewy bodies even at low doses, likely due to hypersensitivity to gabapentinoids in DLB."

Journal • Alzheimer's Disease • CNS Disorders • Dementia • Immunology • Lewy Body Disease • Movement Disorders • Neuralgia • Pain • Parkinson's Disease • Psychiatry

Safety and Efficacy of Mirogabalin in Lumbar Spinal Stenosis Patients with Peripheral Neuropathic Pain on NSAIDs: Post Hoc Analysis of the MiroTAS Study. (PubMed, Pain Ther) - "Mirogabalin was not related to specific patient characteristics regarding the onset of mrADRs and was effective for LSS regardless of patient characteristics. Caution is needed regarding the onset of mrADRs after first administration and uptitration of mirogabalin, but these may not reduce QOL or patient satisfaction. Patients with high numbness scores may be more likely to benefit from treatment with mirogabalin in terms of QOL."

Journal • Retrospective data • Musculoskeletal Diseases • Neuralgia • Orthopedics • Pain • Peripheral Neuropathic Pain

Crisugabalin, a ligand for the α2δ subunit of voltage-gated calcium channels, exhibits no obvious abuse potential in rodents. (PubMed, Pharmacol Biochem Behav) - "Secondly, a rat drug discrimination study was employed to determine the pharmacological similarity between crisugabalin and the training drug midazolam. In the rat spontaneous withdrawal study, crisugabalin demonstrated a very low level of physical dependence. These findings suggest that crisugabalin has minimal to no potential for abuse, thereby establishing itself as a safer option relative to pregabalin and mirogabalin."

Journal • Preclinical • CNS Disorders • Diabetic Neuropathy • Epilepsy • Neuralgia • Pain • Peripheral Neuropathic Pain

Mirogabalin and pregabalin alleviate nociplastic sensitization induced by chemogenetic activation of the central amygdala neurons in rodents. (PubMed, J Pharmacol Sci) - "Administration of an artificial ligand, deschloroclozapine (DCZ; 0.1 mg/kg, i.p.), significantly reduced the 50 %-paw withdrawal threshold, which was significantly elevated by MGB (10 mg/kg, i.p.) and PGB (30 mg/kg, i.p.), restoring it to levels not significantly different from the pre-DCZ baseline. We conclude that MGB and PGB alleviate widespread sensitization in this nociplastic pain model, likely through their action on α2δ-1 subunits within brain circuits that regulate pain sensitivity."

Journal • Preclinical • Pain

Co-treatment with Gabapentinoid and Japanese Herbal Medicine Goshajinkigan for CIPN is Associated with Longer Duration and Higher Dose of Chemotherapy. (PubMed, Adv Ther) - "Combination treatment with gabapentinoid plus GJG might prevent reductions in dose or discontinuation of chemotherapy, and might be effective for the treatment of CIPN."

Journal • Breast Cancer • Colorectal Cancer • Gastric Cancer • Oncology • Pain • Solid Tumor

Adverse events, including fractures, among older patients receiving mirogabalin versus pregabalin: A retrospective cohort study using a large claims database in Japan. (PubMed, Ann Clin Epidemiol) - "Our analyses suggest that the outcome may be less likely in the mirogabalin group; however, the difference appears to be clinically insignificant. Further studies are warranted to confirm these findings."

Adverse events • Journal • Retrospective data • Musculoskeletal Diseases • Neuralgia • Orthopedics • Pain

Efficacy and Safety of Mirogabalin in Patients with Neuropathic Pain Due to Cervical Spondylotic Radiculopathy: Miro-Cens, A Randomized, Controlled, Interventional Study. (PubMed, Pain Ther) - "In patients with CSR, combination therapy with mirogabalin and NSAIDs significantly improved neuropathic pain compared with NSAID monotherapy. No new safety concerns were identified, although caution should be exercised regarding somnolence and dizziness. These findings suggest that concomitant use of mirogabalin with NSAIDs could be tolerable and a novel treatment option for CSR patients with insufficient analgesic effects on NSAIDs."

Journal • Musculoskeletal Pain • Neuralgia • Pain

iPSC screening identifies CACNA2D2 as a potential therapeutic target for FTLD-Tau. (PubMed, Eur J Cell Biol) - "This screening identified gabapentin as an existing drug that suppresses neuronal cell death with suppressed accumulation of Tau oligomers. Treatment with gabapentinoids, including pregabalin and mirogabalin, demonstrated similar neuroprotective effects...Moreover, Neural organoids of FTLD-Tau exhibited features indicative of neurodegeneration, and CACNA2D2 knockout reversed a part of the gene expression alterations associated with these neurodegenerative features. These findings suggest that α2δ-2 may be a promising target for disease-modifying therapies in FTLD-Tau."

Journal • Alzheimer's Disease • CNS Disorders • Frontotemporal Lobar Degeneration

When ocular surface treatment fails: exploring neuropathic ocular pain in aqueous-deficient dry eye due to Sjögren's syndrome treated with mirogabalin: a case study. (PubMed, Immunol Med) - "It can arise as neuropathic ocular pain due to inflammation spreading to the trigeminal nerve. Given the systemic inflammatory condition and characteristics of the ocular pain, administering neuropathic pain medications should be considered as a treatment option."

Journal • Dry Eye Disease • Immunology • Infectious Disease • Inflammation • Interstitial Lung Disease • Neuralgia • Ocular Inflammation • Ophthalmology • Optic Neuritis • Pain • Pneumonia • Respiratory Diseases • Rheumatology • Sjogren's Syndrome

Phase I Study of BM2216 ER Vs. Melogabalin Besilate: Safety, PK, and Food Effect in Healthy Adults (clinicaltrials.gov) - P1 | N=66 | Completed | Sponsor: Zhejiang Anglikang Pharmaceutical Co., Ltd.

New P1 trial • Diabetic Neuropathy • Type 2 Diabetes Mellitus

A Case of Radiation-Induced Lumbosacral Plexopathy after CRT for Rectal Cancer (PubMed, Gan To Kagaku Ryoho) - "The patient was able to walk with a cane after treatment with taking medication of mirogabalin and rehabilitation...In Japan, there have been reports of RILP occurring after radiation therapy for cervical cancer, but no reports related to CRT for rectal cancer. It is a serious adverse event as a late effect, and it is important to understand the pathophysiology."

Journal • Cervical Cancer • Colorectal Cancer • Oncology • Rectal Cancer • Solid Tumor

Risk of Fracture Associated with Pregabalin or Mirogabalin Use: A Case-Case-Time-Control Study Based on Japanese Health Insurance Claims Data. (PubMed, Drug Saf) - "Given this observed risk and the fact that these medications are commonly prescribed to older populations, caution is warranted in clinical use."

Journal • Reimbursement • US reimbursement • Musculoskeletal Diseases • Neuralgia • Orthopedics • Pain

A Study to Evaluate the Safety and Effectiveness of Mirogabalin in Chinese Adult Patients With Diabetic Peripheral Neuropathic Pain (DPNP) in Real-world Clinical Practice Setting (ReMIssion Study) (clinicaltrials.gov) - P=N/A | N=720 | Recruiting | Sponsor: Daiichi Sankyo | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

The Relationship Between Treatment Satisfaction and Medication Understanding Among Patients Taking a Novel Oral Pain Reliever: A Questionnaire-Based Cross-Sectional Study. (PubMed, Pain Ther) - "This study showed that a higher level of understanding of oral pain relievers is associated with higher satisfaction, which may be associated with lower discontinuation rates."

Journal • Observational data • Pain

A Study to Evaluate the Safety and Effectiveness of Mirogabalin in Chinese Adult Patients With Diabetic Peripheral Neuropathic Pain (DPNP) in Real-world Clinical Practice Setting (ReMIssion Study) (clinicaltrials.gov) - P=N/A | N=720 | Not yet recruiting | Sponsor: Daiichi Sankyo

New trial • Real-world evidence • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

Efficacy and safety of mirogabalin therapy for paclitaxel-induced peripheral neuropathy (MICHEL Study): A pilot study. (PubMed, Oncology) - "In the patient satisfaction survey, 14 patients (70%) were satisfied with mirogabalin and 15 patients (75%) wanted to continue. Conclusions Although mirogabalin was not wholly effective for CIPN caused by paclitaxel treatment in breast cancer patients, the satisfaction survey suggests some patient-perceived benefits which cannot be detected by conventional evaluation methods."

Journal • Breast Cancer • Diabetic Neuropathy • Gynecologic Cancers • Neuralgia • Oncology • Pain • Peripheral Neuropathic Pain • Solid Tumor

Mirogabalin as a Therapeutic Option for Neuropathic Pain Emerging Post-Endodontic Treatment: An Observational Study. (PubMed, J Endod) - "Mirogabalin was effective in treating PTTN-occlusal pain."

Journal • Observational data • Neuralgia • Pain

Short-term clinical outcomes of mirogabalin for carpal tunnel syndrome: A single-center retrospective pilot study. (PubMed, J Orthop) - "Further studies are needed to assess long-term outcomes and compare MGB with other treatments. Level IV."

Clinical data • Journal • Retrospective data • Musculoskeletal Pain • Neuralgia • Pain

Mirogabalin as a novel calcium channel α2δ ligand for the treatment of neuropathic pain: a review of clinical update. (PubMed, Front Pharmacol) - "To date, mirogabalin is approved for the general indication of NP in Japan, PNP in South Korea, and DPNP in the Chinese Mainland and DPNP, PHN in Taiwan (China). In summary, mirogabalin emerges as a promising option for NP; further research is warranted to refine wider treatment strategies, flexible dosing in real-world setting."

Journal • Review • Central Neuropathic Pain • Diabetic Neuropathy • Neuralgia • Orthopedics • Pain • Peripheral Neuropathic Pain

Comparison of the Efficacy and Safety of Mirogabalin and Duloxetine in Chemotherapy-induced Peripheral Neuropathy in a Randomized Controlled Trial: a Quality of Life Study in Cancer Survivors (clinicaltrials.gov) - P=N/A | N=66 | Not yet recruiting | Sponsor: Pusan National University Yangsan Hospital

HEOR • New trial • Breast Cancer • Oncology • Pain • Solid Tumor

Duloxetine-induced syndrome of inappropriate antidiuretic hormone secretion in a patient with neuropathic pain. (PubMed, Clin Case Rep) - "We report a case of a patient with small-cell lung cancer who developed SIADH with hypouricemia after duloxetine treatment and discuss the potential underlying mechanisms. SIADH and hypouricemia improved after duloxetine was switched to mirogabalin."

Journal • Cardiovascular • Heart Failure • Lung Cancer • Neuralgia • Oncology • Pain • Small Cell Lung Cancer • Solid Tumor

Non-opioid psychiatric medications for chronic pain: systematic review and meta-analysis. (PubMed, Front Pain Res (Lausanne)) - "The study assessed the effectiveness of duloxetine, mirogabalin, pregabalin, gabapentin, and tricyclic antidepressants (TCAs), including serotonin-norepinephrine reuptake inhibitors (SNRIs), across various chronic pain conditions such as fibromyalgia, neuropathic pain, and chronic low back pain...Conversely, treatments for neuropathic pain and chronic low back pain, including those with amitriptyline and desipramine, did not show significant benefits...No consistent long-term benefits were observed for any of the drugs studied, raising questions about their sustained efficacy in chronic pain management. These findings highlight the need for further research to understand better the role of psychiatric medications in managing specific chronic pain conditions without prematurely concluding that they are ineffective or unsuitable for these purposes."

Journal • Retrospective data • Review • Back Pain • Fibromyalgia • Lumbar Back Pain • Musculoskeletal Pain • Neuralgia • Pain • Psychiatry • Rheumatology

Analgesic effects of co-administration of mirogabalin and diclofenac sodium on neuropathic pain in rats. (PubMed, J Orthop Res) - "Diclofenac sodium inhibits cyclooxygenase-2 and prostaglandin production, related to allodynia. These effects of mirogabalin and diclofenac sodium, respectively, inhibited glia cells strongly, which is presumed to be one of the mechanisms for the effectiveness of their co-administration for neuropathic pain."

Journal • Preclinical • Neuralgia • Pain • GFAP

Marked Improvement in Severe Chronic Penile Pain Following the Administration of Mirogabalin: A Case Report. (PubMed, Cureus) - "This case highlights mirogabalin's potential efficacy in treating CPP with neuropathic characteristics, suggesting it as a viable treatment option for similar cases. Further studies are warranted to explore its broader applicability."

Journal • Pain • Sexual Disorders

Occurrence of somnolence and respiratory depression induced by pregabalin and mirogabalin use and the influence of opioid treatment using the Japanese adverse drug event report database. (PubMed, Pharmazie) - "Multivariable analysis indicated that the use of strong opioid analgesics increased the occurrence of somnolence when combined with pregabalin but not when combined with mirogabalin (p = 0.004). While the safety of concomitant administation of mirogabalin with opioids remains controversial, caution should be exercised when using pregabalin, especially in combination with opioids for neuropathic pain, compared to that for mirogabalin."

Adverse events • Journal • CNS Disorders • Depression • Mood Disorders • Neuralgia • Oncology • Pain • Psychiatry