Efficacy and safety of eliapixant in diabetic neuropathic pain and prediction of placebo responders with an exploratory novel algorithm: results from the randomized controlled phase 2a PUCCINI study

Bouhassira, Didier; Tesfaye, Solomon; Sarkar, Arnab; Soisalon-Soininen, Sari; Stemper, Brigitte; Baron, Ralf

doi:10.1097/j.pain.0000000000003085

Cited by 2 publications

(1 citation statement)

References 48 publications

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“…Recently, eliapixant, a P2 × 3 antagonist (P2 × 3 are ligand-gated cation channels which contribute to the pathogenesis of DNP when increased in expression), entered a randomised, placebo controlled-phase 2a PUCCINI study. However, the results unfortunately failed to illustrate significant differences between changes in pain scores of DNP patients receiving eliapixant vs. those receiving placebo (average of 0.60 in favour of placebo) [ 24 ], which accentuated the difficulties in advancement in treatments for painful diabetic neuropathy.…”

Section: Treatments Against Dnpmentioning

confidence: 99%

Diabetic Neuropathic Pain: Directions for Exploring Treatments

Chen,

Song

2024

Biomedicines

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Diabetic neuropathic pain (DNP) is one of the common and severe late-stage complications of diabetes mellitus, which could greatly influence the patients’ quality of life. Patients with DNP often experience spontaneous pain and evoked pain such as mechanical allodynia and thermal hyperalgesia, meaning that their physical and psychological health are severely impaired. Unfortunately, the mechanisms of DNP remain highly elusive, so substantial breakthrough in effective DNP targeted treatments is still clinically challenging. This article will hence summarise the main mechanisms currently known to underlie DNP pathogenesis, along with describing some of the current and potential treatment methods against diabetic neuropathic pain.

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Section: Treatments Against Dnpmentioning

confidence: 99%

Diabetic Neuropathic Pain: Directions for Exploring Treatments

Chen,

Song

2024

Biomedicines

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Efficacy and safety of eliapixant in endometriosis-associated pelvic pain: the randomized, placebo-controlled phase 2b SCHUMANN study

Parke,

Gude,

Roth

et al. 2024

BMC Women's Health

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Background The SCHUMANN study evaluated the efficacy and safety of the selective P2 × 3 antagonist eliapixant in patients with endometriosis-associated pelvic pain (EAPP). Methods SCHUMANN was a randomized, placebo- and active comparator-controlled, double-blind to placebo and open-label to comparator, parallel-group, multicenter, dose-finding phase 2b study. The participants were women with surgically diagnosed endometriosis who fulfilled defined EAPP criteria. Participants were randomized 1:1:1:1 to twice daily (BID) 25 mg, 75 mg, or 150 mg oral eliapixant or a placebo for 12 weeks. An exploratory once-daily elagolix 150 mg treatment group was also included. The primary endpoint was the absolute change in mean worst EAPP from baseline to the end of intervention (EOI). Results Overall, 215 participants were randomized for treatment (44 to eliapixant 25 mg, 44 to eliapixant 75 mg, 43 to eliapixant 150 mg, 43 to a placebo, and 41 to elagolix 150 mg). For safety reasons, the study was terminated early; both treatment and enrollment stopped immediately, producing less than 50% of the planned number of completers. The study found no significant differences in EAPP reduction from baseline between groups and no significant dose-response model. The elagolix 150 mg group showed better pain reduction than any of the other groups. No new safety signals were observed, relative to the previously known safety profile of eliapixant, which was generally well tolerated. However, one case of moderate and probably drug-induced liver injury in a participant receiving eliapixant 150 mg BID supported the association between eliapixant and a potential increase in liver function values, defined before the start of the phase 2 program. Conclusions This study did not meet its primary objective as no statistically significant or clinically relevant differences in changes of mean worst EAPP from baseline were observed between treatment groups. The single observed case of moderate, probably drug-induced liver injury was the second case in the eliapixant phase 2 program conducted in the following indications: refractory or unexplained chronic cough, diabetic neuropathic pain, overactive bladder, and EAPP. Due to this, the benefit-risk ratio for the study was no longer considered to be positive. Clinical trial registration ClinicalTrials.gov identifier NCT04614246; registered November 3, 2020.

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Efficacy and safety of eliapixant in diabetic neuropathic pain and prediction of placebo responders with an exploratory novel algorithm: results from the randomized controlled phase 2a PUCCINI study

Cited by 2 publications

References 48 publications

Diabetic Neuropathic Pain: Directions for Exploring Treatments

Diabetic Neuropathic Pain: Directions for Exploring Treatments

Efficacy and safety of eliapixant in endometriosis-associated pelvic pain: the randomized, placebo-controlled phase 2b SCHUMANN study

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