PANSS (Positive and Negative Syndrome Scale)
Psychiatry· appears in 400+ cited findings in this library
What it is and how the reviews use it
The PANSS (Positive and Negative Syndrome Scale) is an endpoint/rating scale used in regulatory review documents. It is used to assess the severity of symptoms in conditions like schizophrenia. For instance, in the ML-007C-MA Phase 2 schizophrenia study, the PANSS score range was 80-120, as reported by MapLight Therapeutics, Inc. in their SEC 8-K (2026-05-14). Some studies specify minimum scores on particular PANSS items, such as a minimum score of 4 for specific PANSS items in Study D1050229 (Angelini Pharma — Latuda EMA EPAR public assessment report, p.40), or a PANSS negative subscale score of >20 for inclusion criteria (Minerva Neurosciences, Inc. — SEC 8-K, 2026-05-05).
Reviews in this library utilize PANSS to measure changes from baseline and treatment effects. For example, Alkermes plc's Lybalvi FDA Review (NDA213378, ORIG 1, 2021) reported an LS mean (SE) change from baseline in PANSS of -2.2 (0.47). Johnson & Johnson's Xeplion EMA EPAR public assessment report (EMEA/H/) showed a PANSS total score LS mean difference of -3.8. MapLight Therapeutics, Inc.'s SEC 8-K (2026-07-27) indicated a PANSS Total Score change from baseline (mITT) of -4.5 points.
Real examples — cited to the source page
| Alkermes plc — Lybalvi | LS mean (SE) change from baseline in PANSS | -2.2 (0.47) | Lybalvi FDA Review, p.25 |
| Johnson & Johnson — Xeplion | PANSS total score LS mean difference | -3.8 | Xeplion EMA EPAR public assessment report, p.91 |
| MapLight Therapeutics, Inc. | PANSS Total Score change from baseline (mITT) | -4.5 | SEC 8-K, p.3 |
| Angelini Pharma — Latuda | Mean change relative OL-baseline, PANSS total score change | -18.4 | Latuda EMA EPAR variation assessment report, p.51 |
| HISAMITSU — Secuado | Study HP-3070-GL-04 patients with baseline PANSS total score >= 90 | 75 | Secuado FDA Review, p.74 |
| Otsuka Holdings Co., Ltd. — Rxulti | Response rate (≥ 30% decrease in PANSS Total Score or CGI-I score of 1 or 2) in adolescents | 67.7 | Rxulti EMA EPAR variation assessment repor, p.77 |
| REVIVA PHARMACEUTICALS HOLDINGS, INC. | PANSS general psychopathology change from baseline | -8.7 | SEC 8-K, p.2 |
| Bristol-Myers Squibb Company — Cobenfy | PANSS positive score change from baseline | -3.5 | Cobenfy FDA Review, p.59 |
Different drugs were studied in different trials — these values are not head-to-head comparisons.
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Figures are as stated in the cited source documents. Educational reference only — not medical or investment advice.