Drugs / ALKS 3831
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | bipolar I disorder | 2020-12-29 | “FDA has acknowledged receipt of the company's New Drug Application (NDA) resubmission for ALKS 3831” alkermes.com ↗ |
| Rejected (CRL) | US (FDA) | — | bipolar I disorder | 2020-11-17 | “received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ALKS 3831 (olanzapine/samidorphan)” alkermes.com ↗ |
| Filed | US (FDA) | — | bipolar I disorder | 2019-11-19 | “submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of ALKS 3831” alkermes.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02922426 | Sep 2016 → Jul 2017 | — | Alkermes, Inc. | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT02669758 | Jan 2016 → Jun 2018 | schizophrenia | Alkermes, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 15
| Date | Issuer | Release |
|---|---|---|
| 2021-04-20 | Alkermes, Inc. | Results Alkermes Presents New Data From Psychiatry Portfolio at Virtual 2021 Congress of the Schizophrenia International Research Society alkermes.com ↗
New findings from post hoc analyses assessing the effects of olanzapine/samidorphan compared to olanzapine across multiple cardiometabolic risk factors, including blood pressure, BMI and metabolic syndrome. |
| 2020-12-29 | Alkermes, Inc. | Regulatory FDA Accepts Alkermes' Resubmission of New Drug Application for ALKS 3831 alkermes.com ↗
Alkermes plc (Nasdaq: ALKS) today announced that the 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, and has assigned the application a new Prescription Drug User Fee Act (PDUFA) target action date of June 1, 2021. |
| 2020-11-17 | Alkermes, Inc. | Regulatory Alkermes Receives FDA Complete Response Letter Related to ALKS 3831 Manufacturing Records Review alkermes.com ↗ |
| 2020-10-09 | Alkermes, Inc. | Regulatory FDA Advisory Committee Votes in Support of ALKS 3831 for the Treatment of Schizophrenia and Bipolar I Disorder alkermes.com ↗
The committees jointly voted that samidorphan meaningfully mitigates olanzapine-associated weight gain (16 yes, 1 no) and that the safety profile of ALKS 3831 has been adequately characterized (13 yes, 3 no, 1 abstention). |
| 2020-08-17 | Alkermes, Inc. | Results American Journal of Psychiatry Publishes Data From Alkermes' Phase 3 ENLIGHTEN-2 Weight Study of ALKS 3831 in Patients With Schizophrenia alkermes.com ↗
DUBLIN, Aug. 17, 2020 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced the publication of results from the phase 3 ENLIGHTEN-2 clinical trial of ALKS 3831 (olanzapine/samidorphan) in the peer-reviewed publication, American Journal of Psychiatry. |
| 2020-05-14 | Alkermes, Inc. | Results Alkermes Presents New Data From Schizophrenia Portfolio at Virtual 2020 Congress of the Schizophrenia International Research Society alkermes.com ↗
Results relating to overall safety, tolerability, changes in weight, waist circumference and metabolic parameters are included. |
| 2020-01-28 | Alkermes, Inc. | Regulatory Alkermes Announces U.S. Food and Drug Administration Acceptance of ALKS 3831 New Drug Application for Treatment of Schizophrenia and Bipolar I Disorder alkermes.com ↗ |
| 2019-11-19 | Alkermes, Inc. | Regulatory Alkermes Submits New Drug Application to U.S. Food and Drug Administration for ALKS 3831 for Treatment of Schizophrenia and Bipolar I Disorder alkermes.com ↗
DUBLIN, Nov. 19, 2019 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of ALKS 3831 (olanzapine/samidorphan) for the treatment of schizophrenia and for the treatment of bipolar I disorder. |
| 2018-11-29 | Alkermes, Inc. | Results Alkermes Announces Positive Topline Results From ENLIGHTEN-2 Phase 3 Study of ALKS 3831 in Patients With Schizophrenia alkermes.com ↗
In the study, ALKS 3831 met the pre-specified co-primary endpoints, demonstrating both a lower mean percent weight gain from baseline at six months compared to the olanzapine group (p=0.003) and a lower proportion of patients who gained 10% or more of their baseline body weight at six months compared to the olanzapine group (p=0.003). |
| 2017-06-29 | Alkermes, Inc. | Results Alkermes Announces Positive Preliminary Topline Results From Phase 3 Antipsychotic Efficacy Study of ALKS 3831 for Treatment of Schizophrenia alkermes.com ↗
The study met the prespecified primary endpoint, with ALKS 3831 demonstrating statistically significant reductions from baseline in Positive and Negative Syndrome Scale (PANSS) scores compared to placebo (p<0.001). |
| 2016-03-28 | Alkermes, Inc. | Results Alkermes to Present Data on Schizophrenia Portfolio at Upcoming Schizophrenia International Research Society Conference alkermes.com ↗
Poster #T62, “ALKS 3831 Demonstrated Equivalent Antipsychotic Efficacy While Addressing Weight Gain: Results from a Phase 2, Randomized, Olanzapine-Controlled Study,” will be available during Poster Session III at the Cavaniglia Pavilion on Tuesday, April 5, 2016, 11:00 a.m. – 1:00 p.m. CEST. |
| 2015-04-06 | Alkermes, Inc. | Results Alkermes Announces Positive Topline Results from Complete Six-Month Phase 2 Clinical Trial of ALKS 3831 in Schizophrenia alkermes.com ↗
Data from the completed study support and extend the initial positive results showing ALKS 3831’s favorable efficacy and mean weight gain profile and show for the first time that switching patients from olanzapine to ALKS 3831 resulted in a cessation of mean weight gain. |
| 2015-01-07 | Alkermes, Inc. | Results Alkermes Announces Positive Results of Phase 2 Clinical Trial of ALKS 3831 in Schizophrenia alkermes.com ↗
Data from the 300-patient study showed that ALKS 3831 achieved the study’s primary efficacy endpoint, demonstrating equivalence to olanzapine in reduction from baseline in Positive and Negative Syndrome Scale (PANSS) total scores at Week 12. |
| 2013-05-28 | Alkermes, Inc. | Results Alkermes Presents Positive Results from Phase 1 Study of ALKS 3831 as a Broad Spectrum Treatment for Schizophrenia alkermes.com ↗
In the phase 1 study, subjects who received once-daily, oral administration of ALKS 3831 for three weeks demonstrated significantly less weight gain compared to subjects taking olanzapine. |
| 2013-01-03 | Alkermes, Inc. | Results Alkermes Expands CNS Pipeline and Announces Positive Results from Phase 1 Study of ALKS 3831, a Novel Antipsychotic Therapy for the Treatment of Schizophrenia alkermes.com ↗
Data from the study showed that patients administered ALKS 3831 demonstrated significantly less weight gain compared to patients taking olanzapine. |
All press releases naming this drug 31 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ALKS 3831 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02669758 ↗ |
| Route | Oral | “Oral, bilayer tablet” NCT02922426 ↗ |