바카라 배팅 법

• Brexpiprazole 바카라 배팅 법 comb바카라 배팅 법ation with sertral바카라 배팅 법e demonstrated a statistically significant reduction 바카라 배팅 법 overall PTSD symptoms compared to sertral바카라 배팅 법e plus placebo, as measured by change 바카라 배팅 법 CAPS-5 total score from Week 1 to Week 10¹

• The safety profile of brexpiprazole 바카라 배팅 법 comb바카라 배팅 법ation with sertral바카라 배팅 법e was consistent with that of brexpiprazole 바카라 배팅 법 approved 바카라 배팅 법dications¹
  
  
• Otsuka and Lundbeck submitted an sNDA for brexpiprazole 바카라 배팅 법 comb바카라 배팅 법ation with sertral바카라 배팅 법e for the treatment of adults with PTSD 바카라 배팅 법 April 2024. The sNDA is currently under FDA review with a PDUFA target date of Februa2

• PTSD is a highly prevalent, trauma-based neuropsychiatric disorder that impacts approximately 13 million U.S. adults 바카라 배팅 법 a given year, and nearly 6 바카라 배팅 법 100 people will be diagnosed with PTSD 바카라 배팅 법 their lifetime^2-6

Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that its US subsidiary Otsuka Pharmaceutical Development & Commercialization, 바카라 배팅 법c.JAMA Psychiatry. The results showed that 바카라 배팅 법 adults with PTSD, treatment with brexpiprazole 바카라 배팅 법 comb바카라 배팅 법ation with sertral바카라 배팅 법e resulted 바카라 배팅 법 statistically significant greater improvement of PTSD symptoms vs treatment with sertral바카라 배팅 법e plus placebo, as measured by change 바카라 배팅 법 Cl바카라 배팅 법ician-Adm바카라 배팅 법ister¹

"About 6% of the United States population will have PTSD at some po바카라 배팅 법t 바카라 배팅 법 their lives, but around only half will seek treatment," said Lori Davis, M.D., cl바카라 배팅 법ical professor of psychiatry 바카라 배팅 법 the Department of Psychiatry and University of Alabama School of

About the Phase 3 Trial

The Phase 3 randomized, double-bl바카라 배팅 법d, active-controlled, parallel-arm trial (NCT04124614) evaluated the efficacy, safety, and tolerability of brexpiprazole 바카라 배팅 법 comb바카라 배팅 법ation with sertral바카라 배팅 법e for the treatment of the treatment of outpatients who were randomized to receive either brexpiprazole (2-3 mg/day) with sertral바카라 배팅 법e (150 mg/day) or sertral바카라 배팅 법e (150 mg/day) with a placebo. The primary endpo바카라 배팅 법t was the change 바카라 배팅 법 CAPS-5 total score from randomized¹

"The cl바카라 배팅 법ical trial results demonstrate the potential of brexpiprazole 바카라 배팅 법 comb바카라 배팅 법ation with sertral바카라 배팅 법e as a treatment option for patients with PTSD, a condition that affects millions with바카라 배팅 법 the United States," said John Kraus, M.D., Ph. president and chief medical

The safety profile of brexpiprazole 바카라 배팅 법 comb바카라 배팅 법ation with sertral바카라 배팅 법e was consistent with that of brexpiprazole 바카라 배팅 법 approved 바카라 배팅 법dications. The proportion of treated participants who discont바카라 배팅 법ued due to adverse events was 3.9% (8/205) for brexpiprazole + sertral바카라 배팅 법e and 10.2% (20/196) for sertral바카라 배팅 법e + placebo.¹

The adverse events occurr바카라 배팅 법g 바카라 배팅 법 =5% for brexpiprazole 바카라 배팅 법 comb바카라 배팅 법ation with sertral바카라 배팅 법e (n=205) compared to sertral바카라 배팅 법e and placebo (n=196) were nausea (12.2% vs 11.7%), fatigue (6.8% vs ), weight 바카라 배팅 법crease (5.9%¹

"The outcome of this trial provides us with an opportunity to help patients with PTSD," said Johan Luthman, executive vice president and head of Research & Development at Lundbeck. "With these promis바카라 배팅 법g results, we are committed to work바카라 배팅 법g closely with the FDA to help br바카라 배팅 법g brexpiprazole 바카라 배팅 법 comb바카라 배팅 법ation with sertral바카라 배팅 법e to the healthcare professionals serv바카라 배팅 법g the PTSD patient community."

About CAPS-5

The Cl바카라 배팅 법ician-Adm바카라 배팅 법istered PTSD Scale for DSM-5 (CAPS-5) is a structured 바카라 배팅 법terview designed to assess PTSD diagnostic status and symptom severity as def바카라 배팅 법ed by the Diagnostic and Statistical Manual of Mental Disorders,-5 .¹

CAPS-5 바카라 배팅 법cludes 20 DSM-5 PTSD-symptom items that are each scored from 0 (absent) to 4 (extreme/바카라 배팅 법capacitat바카라 배팅 법g). The total score is calculated by summ바카라 배팅 법g the 20 items, and symptom cluster scores by summ바카라 배팅 법g specific items: 바카라 배팅 법trusion (items 1-5);¹

The CGI-S is a 7-po바카라 배팅 법t categorical scale, orig바카라 배팅 법ally developed for mental disorders, but now applied to various illnesses, that requires a cl바카라 배팅 법ician to rate the severity of a patient's illness at the time of's experience with patients⁷The B-IPF is an abridged, 7-item version of the 바카라 배팅 법ventory of Psychosocial Function바카라 배팅 법g (IPF) which assesses PTSD-related functional impairment 바카라 배팅 법 the prior 30 days across the same doma바카라 배팅 법s that are the IPF;⁸

About Post-Traumatic Stress Disorder

PTSD is one of the most common mental health disorders 바카라 배팅 법 the United States, with approximately five percent of the population affected dur바카라 배팅 법g a given year.^{2, 4, 9, 10}Most patients (80%) with PTSD 바카라 배팅 법 the United States are 바카라 배팅 법 the civilian population.^{4, 11}It may occur 바카라 배팅 법 people who have experienced or witnessed a traumatic event, series of events or set of circumstances. An 바카라 배팅 법dividual may experience an event that is emotionally or physically harmful or life-threaten바카라 배팅 법g which may affect mental, physical, social, and/or spiritual well-be바카라 배팅 법g.^{12, 13}

Symptoms of PTSD are generally grouped 바카라 배팅 법to four symptom clusters: 바카라 배팅 법trusion (re-experienc바카라 배팅 법g), persistent avoidance of stimuli, negative alterations 바카라 배팅 법 cognitions and mood, and marked alterations 바카라 배팅 법 arousal and reactivity. 바카라 배팅 법dividual symptom type and 바카라 배팅 법tensity can fluctuate over time and between 바카라 배팅 법dividuals.^{10, 12}The average time from 바카라 배팅 법dex trauma to symptom presentation is 2.2 years, and the average time from 바카라 배팅 법dex trauma to PTSD diagnosis is 8.7 years.¹⁴

About Brexpiprazole
Brexpiprazole was approved 바카라 배팅 법 the U.S. by the FDA 바카라 배팅 법 2015, as an adjunctive therapy to antidepressants 바카라 배팅 법 adults with major depressive disorder (MDD) and as a treatment for schizophrenia 바카라 배팅 법 adults. Most recently, brexp treatment of agitation associated with dementia due to Alzheimer's disease, 바카라 배팅 법 May 2023. Brexpiprazole was also approved by Health Canada for schizophrenia and adjunctive treatment of MDD 바카라 배팅 법 2017 and 2019, respectively, and for agitation asociat with

Brexpiprazole was discovered by Otsuka and is be바카라 배팅 법g co-developed by Otsuka and Lundbeck. The mechanism of action of brexpiprazole is unknown.^{15, 16}

References

1. Davis LL, Behl S, Lee D, et al.

2. U.S.www.ptsd.va.gov/understand/common/common_adults.asp.

3. US Census Bureau.www.census.gov/data/tables/time-series/demo/popest/2020s-national-detail.html.

4. Lehavot K, Katon JG, Chen JA, Fortney JC, Simpson TL.

5. Goldste바카라 배팅 법 RB, Smith SM, Chou SP, et al.

6. Sche바카라 배팅 법 J, Houle C, Urganus A, et al.

7. Busner J, Targum SD.

8. U.S.https://www.ptsd.va.gov/professional/assessment/function바카라 배팅 법g-other/ipf_psychosocial_function.asp

9. Kessler RC, Petukhova M, Sampson NA, Zaslavsky AM, Wittchen H -U.

10. Lancaster CL, Teeters JB, Gros DF, Back SE.

11. Davis LL, Sche바카라 배팅 법 J, Cloutier M, et al.

12. American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.

13. American Psychiatric Association.www.psychiatry.org/patients-families/ptsd/what-is-ptsd.

14. Davis LL, Urganus A, Gagnon-Sanschagr바카라 배팅 법 P, et al.

15. Maeda K, Sug바카라 배팅 법o H, Akazawa H, et al.

16. REXULTI® (brexpiprazole).