The phase 2 study of ALKS 5461 utilized a sequential parallel comparison design, designed to reduce the impact of clinically meaningful response to treatment with placebo. The study included two four-week, randomized, double-blind stages run in sequence: an Initial Study Stage and a Successive Study Stage. The Successive Study Stage randomized only those patients who were non-responders to placebo in the Initial Study Stage. Both stages of the phase 2 study evaluated two doses of ALKS 5461, a lower dose and a higher dose.
In the phase 2 results for the overall study population, including both the Initial Study Stage and the Successive Study Stage, patients who received either dose of ALKS 5461 for a treatment period of four weeks showed a significant reduction in depressive symptoms from baseline in HAM-D17 and MADRS scores, compared to placebo. The primary endpoint of the phase 2 study was the change from baseline in depressive symptoms over a four-week treatment period in the overall study population, as measured by HAM-D17, compared to placebo. Data from the study showed that ALKS 5461 was generally well tolerated. The most common adverse events observed in the study were nausea, headache and dizziness.
Recent ALKS News
- Alkermes to Participate in the TD Cowen 4th Annual Novel Mechanisms in Neuropsychiatry Conference • PR Newswire (US) • 09/19/2024 08:00:00 PM
- Alkermes Announces Launch of 7th Annual Alkermes Pathways Research Awards® Program • PR Newswire (US) • 09/13/2024 11:00:00 AM
- Alkermes Announces Launch of 7th Annual Alkermes Pathways Research Awards® Program • PR Newswire (US) • 09/13/2024 11:00:00 AM
- Alkermes to Participate in the Morgan Stanley 22nd Annual Global Healthcare Conference • PR Newswire (US) • 08/28/2024 08:00:00 PM
- Alkermes to Participate in the Morgan Stanley 22nd Annual Global Healthcare Conference • PR Newswire (US) • 08/28/2024 08:00:00 PM
- Alkermes Announces Initiation of Vibrance-2 Phase 2 Study Evaluating ALKS 2680 for the Treatment of Narcolepsy Type 2 • PR Newswire (US) • 08/22/2024 11:00:00 AM
- Alkermes Announces Initiation of Vibrance-2 Phase 2 Study Evaluating ALKS 2680 for the Treatment of Narcolepsy Type 2 • PR Newswire (US) • 08/22/2024 11:00:00 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/05/2024 08:13:44 PM
- Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 07/24/2024 08:59:29 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 07/24/2024 01:23:48 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/24/2024 11:05:12 AM
- Alkermes plc Reports Second Quarter 2024 Financial Results • PR Newswire (US) • 07/24/2024 11:00:00 AM
- Alkermes to Report Second Quarter Financial Results on July 24, 2024 • PR Newswire (US) • 07/17/2024 08:00:00 PM
- Alkermes to Report Second Quarter Financial Results on July 24, 2024 • PR Newswire (US) • 07/17/2024 08:00:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/11/2024 12:56:20 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/11/2024 12:55:11 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/04/2024 09:05:16 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/04/2024 09:01:28 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/04/2024 08:53:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/04/2024 08:51:16 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/04/2024 08:49:22 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/04/2024 08:45:15 PM
- Alkermes Presents Data From Phase 1b Study of ALKS 2680 Demonstrating Improved Wakefulness in Patients With Narcolepsy Type 1 at SLEEP 2024 • PR Newswire (US) • 06/03/2024 11:00:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/31/2024 08:05:10 PM
- Alkermes to Participate in Two Upcoming Investor Conferences • PR Newswire (US) • 05/29/2024 08:00:00 PM
VHAI - Vocodia Partners with Leading Political Super PACs to Revolutionize Fundraising Efforts • VHAI • Sep 19, 2024 11:48 AM
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HealthLynked Launches Virtual Urgent Care Through Partnership with Lyric Health. • HLYK • Sep 19, 2024 8:00 AM
Element79 Gold Corp. Appoints Kevin Arias as Advisor to the Board of Directors, Strengthening Strategic Leadership • ELMGF • Sep 18, 2024 10:29 AM
Mawson Finland Limited Further Expands the Known Mineralized Zones at Rajapalot: Palokas step-out drills 7 metres @ 9.1 g/t gold & 706 ppm cobalt • MFL • Sep 17, 2024 9:02 AM
PickleJar Announces Integration With OptCulture to Deliver Holistic Fan Experiences at Venue Point of Sale • PKLE • Sep 17, 2024 8:00 AM