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Details:
Lybalvi (olanzapine and samidorphan) is a once-daily, oral atypical antipsychotic drug. It is approved by USFDA for treatment of adults with schizophrenia, and for the treatment of adults with bipolar I disorder.
Lead Product(s): Olanzapine,Samidorphan L-Malate
Therapeutic Area: Psychiatry/Psychology Product Name: Lybalvi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 03, 2024
Details:
LYBALVI (olanzapine and samidorphan), an atypical antipsychotic drug approved in U.S. for treatment of adults with schizophrenia and for treatment of adults with bipolar I disorder.
Lead Product(s): Olanzapine,Samidorphan L-Malate
Therapeutic Area: Psychiatry/Psychology Product Name: Lybalvi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 07, 2022
Details:
In the ENLIGHTEN clinical development program, LYBALVI demonstrated antipsychotic efficacy, safety and tolerability, including statistically significantly less weight gain than olanzapine in patients with schizophrenia in the ENLIGHTEN-2 study.
Lead Product(s): Olanzapine,Samidorphan L-Malate
Therapeutic Area: Psychiatry/Psychology Product Name: Lybalvi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 01, 2021
Details:
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.
Lead Product(s): Olanzapine,Samidorphan L-Malate
Therapeutic Area: Psychiatry/Psychology Product Name: Lybalvi
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 03, 2021
Details:
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.
Lead Product(s): Olanzapine,Samidorphan L-Malate
Therapeutic Area: Psychiatry/Psychology Product Name: Lybalvi
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 20, 2021
Details:
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.
Lead Product(s): Samidorphan L-Malate,Olanzapine
Therapeutic Area: Psychiatry/Psychology Product Name: ALKS 3831
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 29, 2020
Details:
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.
Lead Product(s): Samidorphan L-Malate,Olanzapine
Therapeutic Area: Psychiatry/Psychology Product Name: ALKS 3831
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 17, 2020
Details:
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.
Lead Product(s): Samidorphan L-Malate,Olanzapine
Therapeutic Area: Psychiatry/Psychology Product Name: ALKS 3831
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 09, 2020
Details:
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.
Lead Product(s): Samidorphan L-Malate,Olanzapine
Therapeutic Area: Psychiatry/Psychology Product Name: ALKS 3831
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 07, 2020
Details:
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.
Lead Product(s): Samidorphan L-Malate,Olanzapine
Therapeutic Area: Psychiatry/Psychology Product Name: ALKS 3831
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 14, 2020
Details:
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.
Lead Product(s): Samidorphan L-Malate,Olanzapine
Therapeutic Area: Psychiatry/Psychology Product Name: ALKS 3831
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 21, 2020
Details:
ENLIGHTEN-2 is the second of two key studies included in the ALKS 3831 ENLIGHTEN clinical development program.
Lead Product(s): Samidorphan L-Malate,Olanzapine
Therapeutic Area: Psychiatry/Psychology Product Name: ALKS 3831
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 17, 2020
Details:
E-poster presentations include results from completed 52-week, open-label safety study of Alks 3831 in patients with schizophrenia.
Lead Product(s): Olanzapine,Samidorphan L-Malate
Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 14, 2020
Details:
ENLIGHTEN-1 was a four-week study evaluating the efficacy, safety and tolerability of ALKS 3831 compared to placebo in 403 patients experiencing an acute exacerbation of schizophrenia.
Lead Product(s): Olanzapine,Samidorphan L-Malate
Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 04, 2020
Details:
The ALKS 3831 NDA includes data from the ENLIGHTEN clinical development program in patients with schizophrenia, as well as pharmacokinetic (PK) bridging data comparing ALKS 3831 and ZYPREXA.
Lead Product(s): Olanzapine,Samidorphan L-Malate
Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 28, 2020
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