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Find Psychiatry/Psychology Drugs in Phase III Clinical Development in IRELAND
In Study 3111-301-001, cariprazine (VRAYLAR®; 1.5mg/day) achieved the primary endpoint of statistically significant improvement on MADRS total score in patients with major depressive disorder with an inadequate response to ongoing antidepressant therapy.
Submission based on clinical trial results findings showing clinically and statistically significant improvement in the Montgomery-Åsberg Depression Rating Scale total score in patients with major depressive disorder treated with VRAYLAR (cariprazine) and an antidepressant.
VRAYLAR® (cariprazine), a partial agonist at dopamine D3, D2, and serotonin 5-HT1A receptors used as atypical antipsychotic, met its primary endpoint demonstrating statistically significant change from baseline to week six in MADRS total score in major depressive disorder.
Highlights of the presentations include: A clinical overview of olanzapine/samidorphan (LYBALVI™), formerly referred to as ALKS 3831, consisting of 18 clinical studies, evaluating LYBALVI's antipsychotic efficacy and weight mitigation profile along with its safety data.
The company's presentations included new exploratory analyses from the phase 3 ENLIGHTEN-2 study of olanzapine/samidorphan (LYBALVI™), formerly referred to as ALKS 3831.
U.S. Food and Drug Administration (FDA) has acknowledged receipt of the company's New Drug Application (NDA) resubmission for ALKS 3831 (olanzapine/samidorphan) for the treatment of adults with schizophrenia and adults with bipolar I disorder.
The AdCom will likely question whether or not ALKS-3831, a formulation of samidorphan and generically available olanzapine, provided a clinically meaningful reduction in the common weight gain side effect versus olanzapine.
The committees voted 16-1 that samidorphan meaningfully mitigates olanzapine-associated weight gain and also ruled that the safety profile of the drug has been adequately characterised by 13-3.
ALKS 3831 is an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder.
The company presented six posters, one of which focused on new outcomes research that analyzed treatment challenges of second-generation antipsychotics, such as weight gain and treatment interruptions, in patients living with schizophrenia or bipolar I disorder.