SPRAVATO label update approved; J&J vision, hip, and lumateperone trials advance

Five Johnson & Johnson-linked items had regulatory or registry activity in the week of September 18, 2026, led by an FDA label approval for SPRAVATO.

• The FDA approved a labeling supplement, SUPPL 26, for SPRAVATO nasal spray with esketamine hydrochloride, sponsored by Janssen Pharms, with a submission status date of 2026-09-17 and an approval letter dated 20260921.¹
• Johnson & Johnson Vision Care Inc. completed a crossover study of a daily disposable toric contact lens. The study was a prospective, multi-site, dispensing, randomized, controlled, double-masked, bilateral wear, 2x2 crossover study to evaluate the safety and effectiveness of the test lens,² enrolling 281 participants (actual)², and results have now been posted.
• Seoul National University Bundang Hospital, with Johnson & Johnson Medical Korea as a collaborator, is recruiting for a cohort study of the collarless Actis hip stem. The main question the study asks is how many participants have a problem with the new hip within five years, such as the hip coming out of place, an infection, a break in the bone around the implant, or the implant becoming loose.³ The target enrollment of 210 hips was derived from an a priori power analysis.³
• Future Options Research, with Johnson & Johnson as a collaborator, has a Phase 4 study of lumateperone added to antidepressant therapy for adults with major depressive disorder experiencing emotional blunting, which is not yet recruiting. The primary endpoint will be change from baseline to week 8 on the Oxford Depression Questionnaire (ODQ).⁴ Planned enrollment is 30 participants (estimated)⁴.
• Johnson & Johnson Vision Care Inc. has a second contact lens comparison study, not yet recruiting, testing Test (Senofilcon A)⁵ against a Control (Serafilcon A) (device): Test Lens⁵ branded Precision7. Planned enrollment is 150 participants (estimated)⁵.