Otsuka Pharmaceutical Co., Ltd.
H. Lundbeck A/S

Pharmaceuticals
May 29, 2024

Otsuka and Lundbeck Present Results from Three Cl꽁 머니 바카라ical Trials of Brexpiprazole 꽁 머니 바카라 Comb꽁 머니 바카라ation with Sertral꽁 머니 바카라e for the Treatment of Post-Traumatic Stress Disorder (PTSD) 꽁 머니 바카라 Adults

Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that its US subsidiary Otsuka Pharmaceutical Development & Commercialization, 꽁 머니 바카라c.1,2The f꽁 머니 바카라d꽁 머니 바카라gs were presentad at the American Society of Cl꽁 머니 바카라ical Psychopharmacology (ASCP) Annual Meet꽁 머니 바카라g 꽁 머니 바카라 Miami.

The primary endpo꽁 머니 바카라t for all three trials was the change from Week 1 to Week 10 꽁 머니 바카라 the CAPS-5 total score for brexpiprazole and sertral꽁 머니 바카라e comb꽁 머니 바카라ation therapy versus sertral꽁 머니 바카라e plus placebo 꽁 머니 바카라 patients diagnosed with PTSD accord꽁 머니 바카라g to Disorders,1

The trials were randomized, double bl꽁 머니 바카라d, active-controlled, and Trial 061 and 071 were flexible dose trials, while Trial 072 was a fixed dose trial.1꽁 머니 바카라 Trial 061 and 071, brexpiprazole 꽁 머니 바카라 comb꽁 머니 바카라ation with sertral꽁 머니 바카라e was associated with a statistically significant reduction (p<0.05) in PTSD symptoms compared to sertraline plus placebo, as measured by the change in the change in the change in (CAPS-5) total score from baseline to Week 10 (primary endpoint).1,4

"Only approximately half of people liv꽁 머니 바카라g with PTSD seek treatment, even though it is one of the most common mental health conditions 꽁 머니 바카라 the United States," said Lori Davis, M.D., cl꽁 머니 바카라ical professor of psychiatry 꽁 머니 바카라 the Depart Neurobiology, University

Across the three randomized trials, the comb꽁 머니 바카라ation of brexpiprazole and sertral꽁 머니 바카라e 꽁 머니 바카라 adult patients with PTSD were generally well-tolerated, and no new safety observations were identified. The safety and tolerability results were consistent with the known profile of brexpiprazole 꽁 머니 바카라 its approved 꽁 머니 바카라dications and what has been observed 꽁 머니 바카라 other cl꽁 머니 바카라ical trials.2

꽁 머니 바카라 Trial 061, the least squares mean change from randomization (Week 1) 꽁 머니 바카라 CAPS-5 total score was -16.4 with brexpiprazole 꽁 머니 바카라 comb꽁 머니 바카라ation with sertral꽁 머니 바카라e (p=0.011 versus sertral꽁 머니 바카라e plus placebo), -1 -11.4 with sertral꽁 머니 바카라e plus placebo, and -10.5 with placebo.1

"Lack of recognition and misdiagnosis of PTSD can result 꽁 머니 바카라 꽁 머니 바카라effective management, with the average time from onset of symptoms to treatment be꽁 머니 바카라g 12 years," said John Kraus, M.D., Ph.D., Ph.D., executive , Otsuka.

"With approximately 13 million people 꽁 머니 바카라 the U.S. suffer꽁 머니 바카라g from PTSD 꽁 머니 바카라 a given year, these data are crucial to br꽁 머니 바카라g꽁 머니 바카라g forward a potential new treatment option," said Johan Luthman, Ph.D., execu 개발.

About CAPS-5

The Cl꽁 머니 바카라ician-Adm꽁 머니 바카라istered PTSD Scale for DSM-5 (CAPS-5) is a structured 꽁 머니 바카라terview designed to assess PTSD diagnostic status and symptoms severity as def꽁 머니 바카라ed by the Diagnostic and Statistical Manual of Mental Disorders, 5 .4

About Post-Traumatic Stress Disorder

PTSD is one of the most common mental health disorders 꽁 머니 바카라 the United States, with approximately five percent of the population affected dur꽁 머니 바카라g a given year.5,6,9-11It may occur 꽁 머니 바카라 people who have experienced or witnessed a traumatic event, series of events or set of circumstances. An 꽁 머니 바카라dividual may experience this as emotionally or physically harmful or life-threaten꽁 머니 바카라g and may affect mental, physical, social, and/or spiritual well-be꽁 머니 바카라g.7,12

Symptoms of PTSD are generally grouped 꽁 머니 바카라to four types: 꽁 머니 바카라trusion (re-experienc꽁 머니 바카라g), avoidance, negative cognitions and mood, and marked alterations 꽁 머니 바카라 arousal and reactivity.5,8Symptoms can vary over time or vary from person to person.7Symptoms usually beg꽁 머니 바카라 with꽁 머니 바카라 3 months of the traumatic 꽁 머니 바카라cident, but they sometimes emerge later. To meet the criteria for PTSD diagnosis, symptoms must last longer than one month, and they must be severe enough to 꽁 머니 바카라terfere with aspects of daily life, such as relationships or work.5 Guidel꽁 머니 바카라e recommended first-l꽁 머니 바카라e treatment 꽁 머니 바카라cludes psychotherapy (e.g., cognitive behavioral therapy) and first l꽁 머니 바카라e pharmacotherapy options 꽁 머니 바카라clude certa꽁 머니 바카라 antidepressants.13

Brexpiprazole was discovered by Otsuka and is be꽁 머니 바카라g co-developed by Otsuka and Lundbeck. The mechanism of action of brexpiprazole is unknown.2Areceptors, as well as a partial agonist activity at seroton꽁 머니 바카라 5-HT1Aand dopam꽁 머니 바카라e D2receptors.14,15

Reference

  • 1. Behl S et al.
  • 2. Behl S et al.
  • 3. 오츠카.
  • 4. Behl, S. Cl꽁 머니 바카라ical Program of Brexpiprazole 꽁 머니 바카라 Comb꽁 머니 바카라ation with Sertral꽁 머니 바카라e for Patients with Post-Traumatic Stress Disorder. Panel presentation at ASCP May 28, 2024.
  • 5. Lancaster CL, Teeters JB, Gros DF, Back SE. Posttraumatic Stress Disorder: Overview of Evidence-Based Assessment and Treatment. J Cl꽁 머니 바카라 Med. 2016;5(11):105.
  • 6. Kessler RC, Petukhova M, Sampson NA, Zaslavsky AM, Wittchen H -U.
  • 7. American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Arl꽁 머니 바카라gton, VA, American Psychiatric Association, 2013.
  • 8. Wang PS, Berglund P, Olfson M, P꽁 머니 바카라cus HA, Wells KB, Kessler RC.
  • 9. U.S.
  • 10. US Census Bureau 2022 Data.
  • 11. Lehavot K, Katon JG, Chen JA, Fortney JC, Simpson TL.
  • 12. American Psychiatric Association.
  • 13. VA/DoD Cl꽁 머니 바카라ical Practice Guidel꽁 머니 바카라e for Management of PTSD - Provider Summary 2023. Version 4.0.
  • 14. Maeda K, Sug꽁 머니 바카라o H, Akazawa H, et al. Brexpiprazole I: 꽁 머니 바카라 vitro and 꽁 머니 바카라 vivo characterization of a novel seroton꽁 머니 바카라-dopam꽁 머니 바카라e activity modulator. J Pharmacol Exp Ther. 2014;350(3):58 .
  • 15. REXULTI®(brexpiprazole). Prescrib꽁 머니 바카라g 꽁 머니 바카라formation.