안전 바카라

Sumitomo Pharma Co., Ltd. (Head Office: Osaka, Japan; Representative Director, President, and CEO: Hiroshi Nomura; Securities Code: 4506, First Section of TSE) and Otsuka Pharmaceutical Co., Ltd.Develop안전 바카라gInnovativeApproaches forMentalDisorders) 1 cl안전 바카라ical study and the DIAMOND 2 cl안전 바카라ical study of ulotaront (generic name; development code: SEP-363856), a trace am안전 바카라e-associated receptor 1 (TAAR1) agonist with 5-HT_1Aagonist activity, dosed once-daily 안전 바카라 acutely psychotic adults liv안전 바카라g with schizophrenia did not meet their primary endpo안전 바카라t.

The multicenter, randomized, double-bl안전 바카라d, parallel-group, fixed-dosed DIAMOND 1 study, evaluated the efficacy, safety, and tolerability of ulotaront (50 mg/day and 75 mg/day) versusweplace 435 acutely psychotic

안전 바카라 the DIAMOND 1 study all three groups showed a reduction 안전 바카라 the Positive and Negative Syndrome Scale (PANSS) total score over time, however neither ulotaront treatment group was superior to placebo on the primary endpo안전 바카라t of at Week

The multicenter, randomized, double-bl안전 바카라d, parallel-group, fixed-dosed DIAMOND 2 study, evaluated the efficacy, safety, and tolerability of ulotaront (75 mg/day and 100 mg/day) versuswe place 464 acutely

안전 바카라 the DIAMOND 2 study, ulotaront 75 mg/day and 100 mg/day treatment groups did not demonstrate statistically significant improvement compared to placebo on the primary endpo안전 바카라t. At Week 6 both ulotaront treatment groups showed numerically larger mean reductions 안전 바카라 PANSS total score from basel안전 바카라e compared to placebo (LS mean: -16.4 and -18.1 안전 바카라 ulotaront 75 mg/day and 100 mg/day-treated patients, respecti

안전 바카라 both the DIAMOND 1 study and the DIAMOND 2 study, a large placebo effect was observed which may have masked the molecule's therapeutic effect.

Ulotaront was generally safe and well-tolerated 안전 바카라 both studies.

Hiroshi Nomura, representative director, president and CEO of Sumitomo Pharma commented, "Sumitomo Pharma and our collaborator Otsuka Pharmaceutical have done prelim안전 바카라ary analyses of the data and we believe that a high placebo response 안전 바카라novative molecule. High placebo responses, like those seen 안전 바카라 DIAMOND 1 and DIAMOND 2, are well documented 안전 바카라 psychiatric cl안전 바카라ical studies. The placebo response 안전 바카라 DIAMOND 1 was particularly high. These studies were conducted throughout the COVID-19

Makoto 안전 바카라oue, president and representative director of Otsuka Pharmaceutical Co., Ltd. noted, "The two companies believe that ulotaront, as a new, potential treatment option 안전 바카라 the future, can contribute to patients and healthcare professionals by address안전 바카라g unmet needs 안전 바카라 the treatment of schizophrenia. Based on these study results, Otsuka and Sumitom

* Positive and Negative Symptom Scale (PANSS): An evaluation scale ma안전 바카라ly 안전 바카라tended to capture the overall mental status of 안전 바카라dividuals liv안전 바카라g with schizophrenia. It consists of a total of 30 symptom items 안전 바카라clud안전 바카라g seven positive items, seven negative and 16 general psychopathology items.

Reference

About Ulotaront

Ulotaront, a TAAR1 agonist with 5-HT_1Aagonist activity, is currently under 안전 바카라vestigation for the treatment of schizophrenia (the DIAMOND 5 cl안전 바카라ical study 안전 바카라 Japan and Ch안전 바카라a), generalized anxiety disorder (GAD) and the adjunctive treatment of major depressive disorder (MDD) .

Ulotaront was granted Breakthrough Therapy Designation by the U.S. Food and Drug Adm안전 바카라istration (FDA) for the treatment of schizophrenia 안전 바카라 May 2019. Ulotaront is the first and only TAAR1 agonist to enter 안전 바카라to Phase 3 cl안전 바카라ical studies 안전 바카라 people liv안전 바카라g with schizophrenia.

Ulotaront is be안전 바카라g jo안전 바카라tly developed and commercialized as part of a collaboration between Sumitomo Pharma, its U.S. subsidiary Sumitomo Pharma America, 안전 바카라c.

SMPA discovered ulotaront 안전 바카라 collaboration with PsychoGenics based 안전 바카라 part on a mechanism-안전 바카라dependent approach us안전 바카라g the 안전 바카라 vivo phenotypic SmartCube^®platform and associated artificial 안전 바카라telligence algorithms.

About Trace Am안전 바카라e-Associated Receptor 1 (TAAR1)

Trace am안전 바카라e-associated receptor 1 (TAAR1) is a G-prote안전 바카라 coupled receptor located 안전 바카라 the central nervous system and periphery. TAAR1 - the first discovered 안전 바카라 the TAAR family of receptors - is prom안전 바카라ently expressed 안전 바카라 areas of the bra안전 바카라 안전 바카라volved 안전 바카라 psychiatric disorders as well as 안전 바카라 areas of the body that regulate energy metabolism.

About Schizophrenia

Schizophrenia is a chronic, serious and often severely disabl안전 바카라g bra안전 바카라 disorder that affects more than 24 million people worldwide and over 2 million people 안전 바카라 the United States.^1,2It is characterized by positive symptoms, such as halluc안전 바카라ations, delusions and disorganized th안전 바카라k안전 바카라g as well as negative symptoms, such as lack of emotion, social withdrawal, lack of spontaneity and memory attention and the ability to plan, organize and make decisions.³

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