FDA validation of the submission dossier prior to the FDA's decision whether to proceed with a full review is expected to take 60 or 74 days depending on whether FDA assigns priority or standard review.

The sNDA submission is based on previously disclosed results, including data from the two clinical phase III trials (#071 flexible dose trial n=416[i] and #072 fixed-dose trial (n=553[ii])), and the clinical phase II (#061 flexible dose trial n=321[iii]). All three trials investigated the treatment of PTSD in adults treated with brexpiprazole in combination with sertraline versus sertraline plus placebo.

• Trial #071 and trial #061 demonstrated that the combination treatment of brexpiprazole and sertraline was superior to treatment with sertraline plus placebo 

• Although trial #072 did not demonstrate superiority of the combination treatment of brexpiprazole and sertraline compared to treatment with sertraline plus placebo, the change from baseline observed in the combination group (brexpiprazole and sertraline) was consistent with the reductions observed in trials #071 and #061

• Brexpiprazole in combination with sertraline was observed to be generally well-tolerated and the safety results of the three trials were consistent with the known safety profile of brexpiprazole

Lundbeck and Otsuka intend to present detailed data from all three trials at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, 28 - 31 May 2024 in Miami, Florida.

About post-traumatic stress disorder (PTSD)
PTSD is a psychiatric disorder that may occur in people who have experienced, or witnessed, a traumatic event, series of events or set of circumstances. An individual may experience this as emotionally or physically harmful or life-threatening and may affect mental, physical, social, and/or spiritual well-being. Examples include natural disasters, serious accidents, terrorist acts, war/combat, rape/sexual assault, historical trauma, intimate partner violence and bullying[iv].

PTSD can occur in people, of any ethnicity, nationality, or culture, and at any age. It affects more than 13 million people in the U.S. and nearly 6 in 100 people will be diagnosed with PTSD in their lifetime[v]. Women are twice as likely as men to have PTSD.

Symptoms of PTSD are generally grouped into four types: intrusive memories, avoidance, negative changes in thinking and mood, and changes in physical and emotional reactions. Symptoms can vary over time or vary from person to person[vi]. Symptoms usually begin within 3 months of the traumatic incident, 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 interfere with aspects of daily life, such as relationships or work[vii].

About brexpiprazole
Brexpiprazole was approved in the U.S. in 2015, as an adjunctive therapy to antidepressants in adults with MDD and as a treatment for schizophrenia in adults. Most recently, brexpiprazole was approved in the U.S. for the treatment of agitation associated with dementia due to Alzheimer's disease in May 2023. Brexpiprazole was also approved by Health Canada for schizophrenia and adjunctive treatment of MDD in 2017 and 2019, respectively. It was approved by the Ministry of Health, Labour and Welfare in Japan and by the European Medicines Agency in 2018 for the treatment of schizophrenia.

Brexpiprazole was discovered by Otsuka and is being co-developed by Otsuka and Lundbeck.  The mechanism of action of brexpiprazole is unknown, however the efficacy of brexpiprazole may be mediated through a combination of partial agonist activity at serotonin 5-HT1A and dopamine D2 receptors, antagonist activity at serotonin 5-HT2A receptors, as well as antagonism of alpha 1B/2C receptors.

Lundbeck contacts

Investors: Media:
                                   
Palle Holm Olesen Thomas Mikkel Mortensen
Vice President, Investor Relations Media Relations Lead, Corp. Communication
PALO@lundbeck.com THMR@lundbeck.com (thmr@lundbeck.com)
+45 30 83 24 26 +45 30 83 30 24

Otsuka contact
                             
Jeffrey Gilbert
Leader, Pharmaceutical PR
Otsuka Pharmaceutical Co., Ltd.
gilbert.jeffrey@otsuka.co.jp
+81 3 6361 7379

About Lundbeck
Lundbeck is a biopharmaceutical company focused exclusively on neuroscience, with more than 70 years of experience in improving the lives of people with neurological and psychiatric diseases.

As a focused innovator, we strive for our research and development programs to tackle some of the most complex challenges. We develop transformative medicines targeting people for whom there are few, if any, treatment options.

Our goal is to create long term value and make a positive contribution to people and societies, everywhere we operate. We are committed to fighting stigma and discrimination, and we act to improve health equity for the people we serve and the communities we are part of.

For additional information, we encourage you to visit our corporate site www.lundbeck.com (https://www.lundbeck.com/global) and connect with us via LinkedIn (https://www.linkedin.com/company/lundbeck/).

About Otsuka
Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: Otsuka-people creating new products for better health worldwide. Otsuka researches, develops, manufactures, and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.

In pharmaceuticals, Otsuka is a leader in the challenging areas of mental, renal, and cardiovascular health and has additional research programs in oncology and on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a "big venture" company at heart, applying a youthful spirit of creativity in everything it does.

Otsuka Pharmaceutical Company, Ltd. is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed approximately 34,400 people worldwide and had consolidated sales of approximately USD 14.2 billion in 2023. 

Otsuka Pharmaceutical Co., Ltd.'s global website is accessible at https://www.otsuka.co.jp/en/.

Citations

[i] ClinicalTrials.gov Identifier: NCT04124614

[ii] ClinicalTrials.gov Identifier: NCT04174170

[iii] ClinicalTrials.gov Identifier: NCT03033069

[iv] American Psychiatric Association. What is posttraumatic stress disorder (PTSD). https://www.psychiatry.org/patients-families/ptsd/what-is-ptsd

[v] U.S. Department of Veteran Affairs. PTSD: National Center for PTSD. https://www.ptsd.va.gov/understand/common/common_adults.asp

[vi] Mayo Clinic. Post-traumatic stress disorder (PTSD). https://www.mayoclinic.org/diseases-conditions/posttraumatic-stress-disorder/symptoms-causes/syc-20355967

[vii] National Institute of Mental Health. Post-Traumatic Stress Disorder. https://www.nimh.nih.gov/health/publications/post-traumatic-stress-disorder-ptsd