Otsuka to Terminate Development of AVP-786
May 22 2024 - 7:00AM
Business Wire
Otsuka Pharmaceutical Co., Ltd. (Otsuka) and its U.S.
subsidiary, Otsuka Pharmaceutical Development &
Commercialization, Inc. (OPDC) announce termination of development
of the novel compound AVP-786, which was in development as a
potential treatment for patients with agitation associated with
dementia due to Alzheimer's disease.
Otsuka initiated Phase 3 clinical trials for AVP-786. In the
top-line results of the Phase 3 trial NCT03393520 (#305 trial) that
Otsuka announced in February this year, no statistically
significant difference was observed between AVP-786 and placebo in
the primary endpoint—average change from baseline to week 12 in the
Cohen-Mansfield Agitation Inventory (CMAI) total score. After a
detailed analysis of results from the completed trial, Otsuka and
OPDC have decided to terminate the development of this drug
candidate.
As a leading company in the central nervous system field, Otsuka
will continue research and development efforts to meet unresolved
medical needs and will continue to focus on addressing agitation
associated with Alzheimer's disease.
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 established a presence in the U.S. in 1973 and today its
U.S. affiliates include Otsuka Pharmaceutical Development &
Commercialization, Inc. (OPDC) and Otsuka America Pharmaceutical,
Inc. (OAPI). These two companies’ 2,250 employees in the U.S.
develop and commercialize medicines in the areas of mental health
and nephrology, using cutting-edge technology to address unmet
healthcare needs.
OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical
Co., Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd.
headquartered in Tokyo, Japan. The Otsuka group of companies
employed 34,400 people worldwide and had consolidated sales of
approximately USD 14.2 billion in 2023.
All Otsuka stories start by taking the road less traveled. Learn
more about Otsuka in the U.S. at www.otsuka-us.com and connect with
us on LinkedIn and Twitter at @OtsukaUS. Otsuka Pharmaceutical Co.,
Ltd.’s global website is accessible at
https://www.otsuka.co.jp/en/.
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version on businesswire.com: https://www.businesswire.com/news/home/20240522034559/en/
Otsuka in the U.S. Robert Murphy Corporate Communications
Otsuka America Pharmaceutical, Inc. robert.murphy@otsuka-us.com +1
609 249 7262
Otsuka outside the U.S. Jeffrey Gilbert Leader,
Pharmaceutical PR Otsuka Pharmaceutical Co., Ltd.
Gilbert.jeffrey.a@otsuka.co.jp