Drugs / ALKS 5461
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Rejected (CRL) | US (FDA) | — | major depressive disorder | 2019-02-01 | “received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ALKS 5461” alkermes.com ↗ |
| Filed | US (FDA) | — | major depressive disorder | 2018-04-16 | “today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ALKS 5461” alkermes.com ↗ |
| Rejected (CRL) | US (FDA) | — | major depressive disorder | 2018-03-30 | “received a Refusal to File letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ALKS 5461” alkermes.com ↗ “FDA's acceptance of the ALKS 5461 NDA and rescission of the Refusal to File letter issued March 30, 2018” alkermes.com ↗ |
| Filed | US (FDA) | — | major depressive disorder | 2018-01-31 | “today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ALKS 5461” alkermes.com ↗ |
| Filed | US (FDA) | — | major depressive disorder | 2017-08-21 | “initiation of its rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), seeking marketing approval of ALKS 5461” alkermes.com ↗ |
Trials 13
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 17 trials | ||||||
| Phase 1 | NCT02508506 | Jul → Dec 2015 | impaired renal function disease | Alkermes, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02545439 | Jul → Oct 2015 | — | Alkermes, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02521857 | Jul → Sep 2015 | — | Alkermes, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02479308 | Jun → Oct 2015 | — | Alkermes, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02452801 | May → Dec 2015 | — | Alkermes, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02272764 | Oct → Nov 2014 | — | Alkermes, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02068105 | Jan → Mar 2014 | — | Alkermes, Inc. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01381107 | May → Jul 2011 | major depressive disorder | Alkermes, Inc. | Completed | No outcome recorded |
| Phase 35 trials · 2 missed | ||||||
| Phase 3 | NCT02218008 | Jul 2014 → Sep 2016 | major depressive disorder | Alkermes, Inc. | Completed | Mixed |
| Phase 3 | NCT02158533 | May 2014 → Dec 2015 | major depressive disorder | Alkermes, Inc. | Completed | Missed primary |
| Phase 3 | NCT02158546 | May 2014 → Dec 2015 | major depressive disorder | Alkermes, Inc. | Completed | Missed primary |
| Phase 3 | NCT02141399 | May 2014 → Nov 2017 | major depressive disorder | Alkermes, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02085135 | Feb → Sep 2014 | major depressive disorder | Alkermes, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 19
| Date | Issuer | Release |
|---|---|---|
| 2019-02-01 | Alkermes, Inc. | Regulatory Alkermes Receives Complete Response Letter From U.S. Food and Drug Administration for ALKS 5461 New Drug Application alkermes.com ↗
Alkermes plc (Nasdaq: ALKS) today announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ALKS 5461 for the adjunctive treatment of major depressive disorder (MDD). |
| 2018-11-01 | Alkermes, Inc. | Regulatory Alkermes Reports on Outcome of FDA Advisory Committee Meeting on ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder alkermes.com ↗
The committee jointly voted that the benefit-risk profile was not adequate to support approval (Vote: 2 Yes/ 21 No). |
| 2018-10-29 | Alkermes, Inc. | Results Alkermes Announces Publication of Phase 3 Data for ALKS 5461 for Adjunctive Treatment of Major Depressive Disorder in Molecular Psychiatry alkermes.com ↗
The Molecular Psychiatry publication includes comprehensive efficacy and safety results from FORWARD-4 (Study 205) and FORWARD-5 (Study 207), and a review of a pooled analysis of the two datasets. |
| 2018-05-23 | Alkermes, Inc. | Results Alkermes to Present Data on Depression and Schizophrenia Portfolios at Upcoming American Society of Clinical Psychopharmacology Annual Meeting alkermes.com ↗
In the study, ALKS 5461, a combination of buprenorphine with the mu-opioid receptor antagonist samidorphan, posed a low risk of abuse. |
| 2018-04-26 | Alkermes, Inc. | Regulatory Alkermes Plc Reports First Quarter 2018 Financial Results alkermes.com ↗
ALKS 5461: New Drug Application (NDA) accepted for filing by U.S. Food and Drug Administration (FDA) for the adjunctive treatment of major depressive disorder (MDD) in patients with inadequate response to standard antidepressant therapy. |
| 2018-04-16 | Alkermes, Inc. | Regulatory Alkermes Announces FDA Acceptance for Review of New Drug Application for ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder alkermes.com ↗
FDA's acceptance of the ALKS 5461 NDA and rescission of the Refusal to File letter issued March 30, 2018 follows productive interactions with the Agency in which Alkermes clarified certain aspects of the NDA submission. |
| 2018-04-02 | Alkermes, Inc. | Regulatory Alkermes Receives Refusal to File Letter From FDA for ALKS 5461 alkermes.com ↗
Alkermes plc (Nasdaq: ALKS) today announced that it received a Refusal to File letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ALKS 5461 |
| 2018-01-31 | Alkermes, Inc. | Regulatory Alkermes Submits New Drug Application To U.S. FDA For ALKS 5461 For The Adjunctive Treatment Of Major Depressive Disorder alkermes.com ↗
With this regulatory submission, we are one step closer to our goal of bringing this important new medicine to patients, families and healthcare professionals, who are eager for new treatment options. |
| 2017-08-21 | Alkermes, Inc. | Regulatory Alkermes Initiates Rolling Submission of ALKS 5461 New Drug Application for Major Depressive Disorder alkermes.com ↗
The initiation of the rolling submission for ALKS 5461 is an important first step in the registration process for ALKS 5461, as we work to bring this potential new medicine to patients suffering from major depressive disorder. |
| 2016-10-20 | Alkermes, Inc. | Results Alkermes Announces Positive Topline Results From FORWARD-5 Pivotal Phase 3 Study of ALKS 5461 for Major Depressive Disorder alkermes.com ↗
The study met its prespecified primary endpoint showing treatment with ALKS 5461 significantly reduced symptoms of depression in patients with MDD compared to placebo. |
| 2016-01-21 | Alkermes, Inc. | Results Alkermes Announces Topline Results of FORWARD-3 and FORWARD-4, Two Phase 3 Studies of ALKS 5461 in Major Depressive Disorder alkermes.com ↗
Neither of the two studies met the prespecified primary efficacy endpoint, which compared ALKS 5461 to placebo on the change from baseline on the Montgomery–Åsberg Depression Rating Scale (MADRS). |
| 2015-12-16 | Alkermes, Inc. | Results Alkermes Announces Achievement of Milestones for CNS Medicines in Proprietary Product and Pipeline Portfolio alkermes.com ↗
In the study, all doses of ALKS 5461 tested met the trial’s primary endpoint and demonstrated a statistically significant and meaningful reduction in abuse potential compared to buprenorphine (p<0.001). |
| 2015-01-06 | Alkermes, Inc. | Results Alkermes Announces Positive Results From Study of ALKS 5461 for Treatment of Major Depressive Disorder alkermes.com ↗
Data from the 66-patient study showed that ALKS 5461 was generally well tolerated in both of the two titration schedules evaluated – one-week and two-week dose escalation schedules. |
| 2013-12-09 | Alkermes, Inc. | Results Alkermes Presents Data on Two Late-Stage Clinical Candidates, Aripiprazole Lauroxil and ALKS 5461, at 52nd Annual ACNP Meeting alkermes.com ↗
Additional Efficacy Analyses of Phase 2 Study Results for ALKS 5461 Show Significant Responder and Remission Rates in Patients With Inadequate Response to Conventional Antidepressants |
| 2013-10-10 | Alkermes, Inc. | Regulatory Alkermes Receives Fast Track Designation for ALKS 5461 for Major Depressive Disorder alkermes.com ↗
Alkermes plc (NASDAQ: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track status for ALKS 5461 for the adjunctive treatment of major depressive disorder (MDD) in patients with an inadequate response to standard therapies. |
| 2013-05-31 | Alkermes, Inc. | Results Alkermes Presents Positive Results from Phase 2 Clinical Study of ALKS 5461 in Major Depressive Disorder at 53rd Annual NCDEU Meeting alkermes.com ↗
In the phase 2 study, ALKS 5461 met its primary endpoint, met key secondary endpoints and demonstrated significant reduction in depressive symptoms versus placebo. |
| 2013-04-17 | Alkermes, Inc. | Results Alkermes Announces Positive Results from Phase 2 Clinical Study of ALKS 5461 for Major Depressive Disorder alkermes.com ↗
Data from the study showed that ALKS 5461 significantly reduced depressive symptoms across a range of standard measures including the study’s primary outcome measure, the Hamilton Depression Rating Scale (HAM-D17) (p=0.026), the Montgomery–Åsberg Depression Rating Scale (MADRS) (p=0.004) and the Clinical Global Impression – Severity Scale (CGI-S) (p=0.035). |
| 2012-05-29 | Alkermes, Inc. | Results Alkermes Presents Positive Clinical Data of ALKS 5461 at 52nd Annual New Clinical Drug Evaluation Unit Meeting alkermes.com ↗
In addition, data from the study showed that ALKS 5461 was generally well tolerated. |
| 2012-01-04 | Alkermes, Inc. | Results Alkermes Announces Positive Results From Clinical Study of ALKS 5461 for Major Depressive Disorder alkermes.com ↗
Alkermes plc (NASDAQ: ALKS) today announced positive topline results from a phase 1/2 study of ALKS 5461, a novel drug compound for major depressive disorder (MDD) in patients who have an inadequate response to standard therapies for clinical depression. |
All press releases naming this drug 28 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ALKS 5461 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02158546 ↗ |
| Route | Other | “Sublingual administration once daily for 7 consecutive days.” NCT01381107 ↗ |