SLOUGH, England and
RICHMOND, Va., Dec. 12, 2017 /PRNewswire/ -- Indivior PLC
(LON: INDV) (the 'Company') today announces that the U.S. Food and
Drug Administration (FDA) has accepted the New Drug Application
(NDA) for RBP-7000, an investigational, once-monthly injectable
risperidone in the ATRIGEL® delivery system for the
treatment of schizophrenia. The NDA, which was submitted on
September 28, 2017, is based on data
from the pivotal Phase 3 study assessing clinical efficacy and
safety and from the long-term safety study of RBP-7000. The FDA has
set a PDUFA (Prescription Drug User Fee Act) target action date of
July 28, 2018.
"The FDA acceptance of our RBP-7000 NDA is a significant
milestone for Indivior as we expand our treatment portfolio to
offer a meaningful therapeutic option to help address
non-compliance with medication administration in the treatment of
schizophrenia," said Christian
Heidbreder, Ph.D., Chief Scientific Officer of Indivior. "We
look forward to closely working with the Agency during the review
process to support the approval of RBP-7000 and to provide both
physicians and patients this innovative treatment option."
This NDA submission includes the results from the pivotal Phase
3 study (RB-US-09-0010) assessing the efficacy and safety of
RBP-7000 and an open-label, long-term safety study (RB-US-13-0005).
In the pivotal randomized, double-blind, placebo-controlled study,
RBP-7000 demonstrated statistically significant clinical
improvement compared to placebo based on changes in mean Positive
and Negative Syndrome Scale (PANSS) total and Clinical Global
Impression-Severity of Illness (CGI-S) scores at 8 weeks.
About RBP-7000
RBP-7000 IS AN INVESTIGATIONAL PRODUCT WHOSE SAFETY AND
EFFICACY IS CURRENTLY UNDER REVIEW BY THE U.S. FOOD AND DRUG
ADMINISTRATION.
RBP-7000 is a novel extended-release product using the
ATRIGEL® delivery system for the subcutaneous (SC)
administration of risperidone once monthly for the treatment of
schizophrenia.
The results of the pivotal Phase 3 studies to assess the
efficacy, safety and tolerability of RBP-7000 in subjects with
acute schizophrenia were recently published.1,2
The most common adverse reactions in clinical trials (reported
in ≥ 5% and greater than placebo group) were weight increase,
constipation, sedation/somnolence, pain in extremity, back pain,
akathisia, anxiety and musculoskeletal pain. The most common
injection site reactions (≥ 5%) were injection site pain, erythema
and induration/nodule.
About Schizophrenia
Schizophrenia is a chronic disorder characterized by a life-long
pattern of acute psychotic episodes superimposed upon chronically
poor psychosocial adjustment. The symptoms can be grouped into four
domains: positive (for example, delusions, hallucinations,
disorganized speech and behavior); negative (for example, social
withdrawal, avolition, blunted effect); cognitive (for example,
impaired sustained attention, executive function and working
memory) and affective (for example, anxiety and depression,
hostility and aggression, increased risk of suicide) symptoms.
These occur in different combinations and to a different degree in
each patient. Given the extensive heterogeneity of symptoms among
individual patients, schizophrenia can be considered a clinical
syndrome rather than a single disease entity. An estimated 23
million people worldwide in 2015 were affected with
schizophrenia.3
About Indivior
Indivior is a global specialty pharmaceutical company with a
20-year legacy of leadership in patient advocacy and health policy
while providing education on evidence-based treatment models that
have revolutionized modern addiction treatment. The name is the
fusion of the words individual and endeavour, and the tagline
"Focus on you" makes the Company's commitment clear. Indivior is
dedicated to transforming addiction from a global human crisis to a
recognized and treated chronic disease. Building on its global
portfolio of opioid dependence treatments, Indivior has a strong
pipeline of product candidates designed to both expand on its
heritage in this category and address other chronic conditions and
co-occurring disorders of addiction, including alcohol use disorder
and schizophrenia. Headquartered in the
United States in Richmond,
VA, Indivior employs more than 900 individuals globally and
its portfolio of products is available in over 40 countries
worldwide. Visit www.indivior.com to learn more.
Forward-Looking Statements
This announcement contains certain statements that are
forward-looking and which should be considered, amongst other
statutory provisions, in light of the safe harbour provisions of
the United States Private Securities Litigation Reform Act of 1995.
By their nature, forward-looking statements involve risk and
uncertainty as they relate to events or circumstances that may or
may not occur in the future. Actual results may differ materially
from those expressed or implied in such statements because they
relate to future events. Forward-looking statements include, among
other things, statements regarding the Indivior Group's financial
guidance for 2017 and its medium- and long-term growth outlook, its
operational goals, its product development pipeline and statements
regarding ongoing litigation.
Various factors may cause differences between Indivior's
expectations and actual results, including: factors affecting sales
of Indivior Group's products; the outcome of research and
development activities; decisions by regulatory authorities
regarding the Indivior Group's drug applications; the speed with
which regulatory authorizations, pricing approvals and product
launches may be achieved; the outcome of post-approval clinical
trials; competitive developments; difficulties or delays in
manufacturing; the impact of existing and future legislation and
regulatory provisions on product exclusivity; trends toward managed
care and healthcare cost containment; legislation or regulatory
action affecting pharmaceutical product pricing, reimbursement or
access; claims and concerns that may arise regarding the safety or
efficacy of the Indivior Group's products and product candidates;
risks related to legal proceedings; the Indivior Group's ability to
protect its patents and other intellectual property; the outcome of
patent infringement litigation relating to Indivior Group's
products, including the ongoing ANDA lawsuits; changes in
governmental laws and regulations; issues related to the
outsourcing of certain operational and staff functions to third
parties; uncertainties related to general economic, political,
business, industry, regulatory and market conditions; and the
impact of acquisitions, divestitures, restructurings, internal
reorganizations, product recalls and withdrawals and other unusual
items.
REFERENCES
- Nasser AF, Henderson DC, Fava M, Fudala PJ, Twumasi-Ankrah P,
Kouassi A, Heidbreder C. Efficacy, safety and tolerability of
RBP-7000 once monthly risperidone for the treatment of acute
schizophrenia: An 8-week, randomized, double-blind,
placebo-controlled, multicenter Phase 3 study. J. Clin.
Psychopharmacology, 2016, 36(2): 130-140.
- Isitt JJ, Nadipelli VR, Kouassi A, Fava M, Heidbreder C.
Health-related quality of life in acute schizophrenia patients
treated with RBP-7000 once monthly risperidone: An 8-week,
randomized, double-blind, placebo-controlled, multicenter phase 3
study. Schizophr Res., 2016, 174(1-3): 126-131.
- GBD 2015 Disease and Injury Incidence and Prevalence
Collaborators. Global, regional, and national incidence,
prevalence, and years lived with disability for 310 diseases and
injuries, 1990-2015: a systematic analysis for the Global Burden of
Disease Study 2015. The Lancet, 2016, 388:1545-602.
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SOURCE Indivior PLC