AbbVie’s Cariprazine (VRAYLAR®) Met Primary Endpoint in Phase 3 Study as an Adjunctive Treatment for Major Depressive Disorder

– In a Phase 3 clinical trial, Study 3111-301-001, cariprazine (VRAYLAR®) met its primary endpoint demonstrating statistically significant change from baseline to week six in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score in patients with major depressive disorder
– In a second Phase 3 clinical trial, Study 3111-302-001, cariprazine demonstrated numerical improvement in depressive symptoms from baseline to week six in MADRS total score compared with placebo but did not achieve statistical significance
– Safety data were consistent with the established safety profile of cariprazine across indications with no new safety signals identified

AbbVie moment blazoned top- line results from two Phase 3 clinical trials, Study3111-301-001 and Study3111-302-001, assessing the efficacity and safety of cariprazine (VRAYLAR ®) as an spare treatment for cases with major depressive complaint (MDD). In Study3111-301-001, cariprazine showed a statistically significant change from birth to week six in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score compared with placebo. Cases treated with cariprazine at1.5 mg/ day achieved bettered MADRS total score at week six compared to placebo (p- value = 0.0050). Cases treated with cariprazine at3.0 mg/ day demonstrated enhancement in MADRS total score at week six over placebo but didn’t meet statistical significance (p- value = 0.0727). In Study3111-302-001, cariprazine demonstrated numerical enhancement in depressive symptoms from birth to week six in MADRS total score compared with placebo but didn’t meet its primary endpoint for either the1.5 mg/ day or3.0 mg/ day cure.

In a preliminarily published Phase2/3 enrollment- enabling study, RGH-MD-75, cases treated with cariprazine flexible boluses of2.0 –4.5 mg/ day in addition to ongoing antidepressant remedy (ADT) met the primary endpoint and achieved bettered MADRS total scores at week eight compared to placebo (p- value = 0.0114).
Grounded on the positive results of studies3111-301-001 and RGH-MD-75, and the summation of data reported, AbbVie intends to submit a supplemental New Drug Application (sNDA) with theU.S. Food and Drug Administration for the expanded use of cariprazine for the spare treatment of MDD.
Full results from studies3111-301-001 and3111-302-001 will be presented at a unborn medical meeting.

MDD is a common condition with 19 million people of all periods affected in the United States.1 The World Health Organization lists depression as the third- leading cause of disability worldwide and as a major contributor to the overall global burden of complaint. Symptoms can include depressed mood, loss of pleasure or interest in conditioning, changes in appetite or weight, changes in sleep, psychomotor agitation, loss of energy, passions of worthlessness, indecisiveness, and current studies of death.2 In the United States, the mean age of onset for the first occasion is 26 times old, and MDD represents an estimated$ 211 billion profitable burden.4
Cariprazine is retailed as VRAYLAR in the United States and is FDA-approved to treat depressive, acute manic and mixed occurrences associated with bipolar I complaint, as well as schizophrenia in grown-ups. Cariprazine is beingco-developed by AbbVie and Gedeon Richter Plc. Further than cases worldwide have been treated with cariprazine across further than 20 clinical trials assessing the efficacity and safety of cariprazine for a broad range of psychiatric diseases.

About Study RGH-MD-75
Study RGH-MD-75 is a randomized, double-eyeless, placebo- controlled, flexible- cure, inpatient, multicenter trial with 808 actors, conducted in United States, Estonia, Finland, Slovakia, Ukraine and Sweden. After 7-14 days of webbing and flop of banned specifics, eligible cases entered an 8-week, double-eyeless treatment period in which they continued antidepressant treatment and were randomized (111) to spare cariprazine 1-2 mg/ day, cariprazine 2-4.5 mg/ day, or placebo. After double-eyeless treatment, cases entered a 1-week safety follow-up period. Data from Study RGH-MD-75 were published in the Journal of Clinical Psychiatry.5

About VRAYLAR ® (cariprazine)
VRAYLAR is an oral, formerly-diurnal atypical antipsychotic approved for the acute treatment of grown-ups with manic or mixed occurrences associated with bipolar I complaint (3 to 6 mg/ day) and for the treatment of depressive occurrences associated with bipolar I complaint (bipolar depression) in grown-ups (1.5 or 3 mg/ day). VRAYLAR is also approved for the treatment of schizophrenia in grown-ups (1.5 to 6 mg/ day).
While the medium of action of VRAYLAR is unknown, the efficacity of VRAYLAR could be intermediated through a combination of partial agonist exertion at central dopamine D ₂ and serotonin 5-HT1A receptors and antagonist exertion at serotonin 5-HT2A receptors. Pharmacodynamic studies with cariprazine have shown that it acts as a partial agonist with high list affinity at dopamine D3, dopamine D2, and serotonin 5-HT1A receptors. Cariprazine demonstrated up to
8-fold lesser in vitro affinity for dopamine D3 vs D2 receptors Cariprazine also acts as an antagonist at serotonin 5-HT2B and 5-HT2A receptors with high and moderate list affinity, independently as well as it binds to the histamine H1 receptors. VRAYLAR shows lower list affinity to the serotonin 5-HT2C and α1A-adrenergic receptors and has no perceptible affinity for cholinergic muscarinic receptors. The clinical significance of these in vitro data is unknown.

VRAYLAR is being developed concertedly by AbbVie and Gedeon Richter Plc, with AbbVie responsible for commercialization in theU.S., Canada, Japan, Taiwan and certain Latin American countries ( including Argentina, Bolivia, Brazil, Chile, Colombia, Ecuador, Mexico, Peru and Venezuela).
About AbbVie
AbbVie’s charge is to discover and deliver innovative drugs that break serious health issues moment and address the medical challenges of hereafter. We strive to have a remarkable impact on people’s lives across several crucial remedial areas immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio.

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