Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; “Ono”) announced that ONO-1110, an endocannabinoid modulator, demonstrated efficacy signals in Phase 2 clinical studies in postherpetic neuralgia (PHN), fibromyalgia (FM), and Hunner-type interstitial cystitis (HIC). Additional Phase 2 clinical studies of ONO-1110 were conducted in major depressive disorder (MDD) and social anxiety disorder (SAD).

Although the ONO-1110-04, ONO-1110-05, and ONO-1110-06 studies in PHN, FM, and HIC, respectively, did not meet their primary endpoints, efficacy signals suggesting improvement in pain scores assessed using the Numerical Rating Scale (NRS) were observed in prespecified subgroup analyses and exploratory post hoc analyses. ONO-1110 also demonstrated a favorable safety profile across all five studies.

Based on these results, Ono is planning further clinical studies of ONO-1110 in PHN, FM, and HIC. No efficacy signals were observed in MDD or SAD, and no further clinical studies are planned in these indications.

Detailed results from these studies will be presented at future conferences and through other appropriate channels.