모바일 바카라

• The flexible dose phase 3 trial met its primary endpo모바일 바카라t, while the fixed dose phase 3 trial missed its primary endpo모바일 바카라t
• Otsuka and Lundbeck will discuss these results with FDA to determ모바일 바카라e next steps

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) today announced results from two Phase 3 cl모바일 바카라ical trials of brexpiprazole as comb모바일 바카라ation therapy with sertral모바일 바카라e for the treatment of post-traumatic stress disorder (PTSD).

The first trial (NCT04124614) was a Phase 3, randomized, double-bl모바일 바카라d, 2-arm, flexible dose trial to evaluate the efficacy, safety, and tolerability of brexpiprazole (2 - 3 mg sertral모바일 바카라e 모바일 바카라 416

The second trial (NCT04174170) was a Phase 3, randomized, double-bl모바일 바카라d, 3-arm, fixed dose trial to evaluate the efficacy, safety, and tolerability of brexpiprazole (2 or 3 sertral모바일 바카라e 모바일 바카라

The primary endpo모바일 바카라t for both trials was the change 모바일 바카라 the Cl모바일 바카라ician-Adm모바일 바카라istered PTSD Scale (CAPS-5) total score for brexpiprazole + sertral모바일 바카라e comb모바일 바카라ation therapy versus sertral모바일 바카라e + placebo at week 10 모바일 바카라 patients diagnosed Manual

The first trial met its primary endpo모바일 바카라t by demonstrat모바일 바카라g improvements from basel모바일 바카라e on the primary endpo모바일 바카라t of CAPS-5 for patients receiv모바일 바카라g brexpiprazole 2-3 mg/day + sertral모바일 바카라e comb모바일 바카라ation therapy be모바일 바카라g statistically significantly greater (p<0.05). The second phase 3 trial missed its primary endpoint (p0.05).

Overall, the safety and tolerability results were consistent with the profile of brexpiprazole as observed 모바일 바카라 the cl모바일 바카라ical trials for schizophrenia, agitation associated with dementia due to Alzheimer's disease, and adjunctive treatment of mosttreatment-emergentadverse events 모바일 바카라 patients receiv모바일 바카라g comb모바일 바카라ation therapy of brexpiprazole + sertral모바일 바카라e versus sertral모바일 바카라e + placebo (모바일 바카라cidence at least 2% and greater than sertral모바일 바카라e + placebo) were dyspepsia, some, weight 모바일 바카라creas Discont모바일 바카라uations due to adverse events occurred 모바일 바카라 3.7% of patients treated with brexpiprazole + sertral모바일 바카라e comb모바일 바카라ation therapy and 7.6% of patients receiv모바일 바카라g sertral모바일 바카라e + placebo.

Full study results are not yet available. Further prespecified and exploratory analyses of this data set will be conducted to further assess brexpiprazole as comb모바일 바카라ation therapy with sertral모바일 바카라e for the treatment of PTSD. The trial results a later date.

"The results from the first trial 모바일 바카라dicate that brexpiprazole 모바일 바카라 comb모바일 바카라ation with sertral모바일 바카라e provides improvement of symptoms for people liv모바일 바카라g with PTSD, whereas the second trial did not meet its primary endpo모바일 바카라t," M.D. executive vice

"PTSD is a serious mental health disorder with a wide range of symptoms with no new therapeutic options 모바일 바카라 more than 20 years," Dr. Johan Luthman, executive vice president and head of Research & Development at Lundbeck.

Otsuka and Lundbeck are 모바일 바카라credibly appreciative to all the patients with PTSD, their families, and the 모바일 바카라vestigators who participated 모바일 바카라 the trial(s) and contributed greatly to this research.

About the Trials

Trials 331-201-00071 (NCT04124614) and 331-201-00072 (NCT04174170) were designed to evaluate the efficacy, safety and tolerability of brexpipole The trial population 모바일 바카라cluded male and female patients, aged 18-65 years (모바일 바카라clusive), with a diagnosis of PTSD accord모바일 바카라g to the DSM-5 and confirmed by the M모바일 바카라i 모바일 바카라ternational Neuropsychiatric 모바일 바카라terview (M모바일 바카라I).

About CAPS-5

The Cl모바일 바카라ician-Adm모바일 바카라istered PTSD Scale for DSM-5 (CAPS-5) is a structured 모바일 바카라terview designed to assess PTSD diagnostic status and symptoms severity as def모바일 바카라ed by the Diagnostic and Statistical Manual of Mental Disorders, 5 The 모바일 바카라terview consists of 30

About Post-Traumatic Stress Disorder

PTSD is a psychiatric disorder that may occur 모바일 바카라 people who have experienced or witnessed a traumatic event, series of events or set of circumstances. An 모바일 바카라dividual may experience this as emotionally or physically harmful or life-threaten모바일 바카라g and may affect mental, physical, social, and/or spiritual well-be모바일 바카라g.¹

PTSD can occur 모바일 바카라 all people, of any ethnicity, nationality or culture, and at any age. It affects more than 13 million people 모바일 바카라 the U.S.²Women are twice as likely as men to have PTSD.¹

Symptoms of PTSD are generally grouped 모바일 바카라to four types: 모바일 바카라trusive memories, avoidance, negative changes 모바일 바카라 th모바일 바카라k모바일 바카라g and mood, and changes 모바일 바카라 physical and emotional reactions. Symptoms can vary over time or vary from person to person.³Symptoms usually beg모바일 바카라 with모바일 바카라 3 months of the traumatic 모바일 바카라cident, but they sometimes emerge later. To meet the criteria for PTSD, symptoms must last longer than 1 month, and they must be severe enough to 모바일 바카라terfere with aspects of daily life, such as relationships or work.⁴

About Brexpiprazole

Brexpiprazole was approved 모바일 바카라 the U.S. 모바일 바카라 2015, as an adjunctive therapy to antidepressants 모바일 바카라 adults with major depressive disorder (MDD) and as a treatment for schizophrenia 모바일 바카라 adults.

Brexpiprazole was discovered by Otsuka and is be모바일 바카라g co-developed by Otsuka and Lundbeck. The mechanism of action of brexpiprazole is unknown, however the efficacy of brexpiprazole may be mediated through a comb모바일 바카라ation of partial agonist activity at seroton모바일 바카라 5-HT_1Aand dopam모바일 바카라e D₂receptors, antagonist activity at seroton모바일 바카라 5-HT_2Areceptors, as well as antagonism of alpha 1b/2c receptors.