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 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
- Alkermes to Participate in Two Upcoming Investor Conferences • PR Newswire (US) • 05/29/2024 08:00:00 PM
- Alkermes to Present New Clinical Data for ALKS 2680 at SLEEP 2024 • PR Newswire (US) • 05/28/2024 11:00:00 AM
- Alkermes to Present New Clinical Data for ALKS 2680 at SLEEP 2024 • PR Newswire (US) • 05/28/2024 11:00:00 AM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 05/14/2024 08:30:08 PM
- Alkermes Highlights Data Presentations Related to its Psychiatry Franchise at Spring 2024 Scientific Conferences • PR Newswire (US) • 05/14/2024 11:00:00 AM
- Alkermes Highlights Data Presentations Related to its Psychiatry Franchise at Spring 2024 Scientific Conferences • PR Newswire (US) • 05/14/2024 11:00:00 AM
- Alkermes plc Completes Sale of Athlone, Ireland Facility to Novo Nordisk • PR Newswire (US) • 05/02/2024 11:00:00 AM
- Alkermes plc Reports First Quarter 2024 Financial Results • PR Newswire (US) • 05/01/2024 11:00:00 AM
- Alkermes Announces Initiation of Vibrance-1 Phase 2 Study Evaluating ALKS 2680 for the Treatment of Narcolepsy Type 1 • PR Newswire (US) • 04/24/2024 11:00:00 AM
- Alkermes to Report First Quarter Financial Results on May 1, 2024 • PR Newswire (US) • 04/17/2024 08:00:00 PM
- Alkermes to Report First Quarter Financial Results on May 1, 2024 • PR Newswire (US) • 04/17/2024 08:00:00 PM
- Alkermes Announces Positive Topline Results From Phase 1b Study of ALKS 2680 Demonstrating Improved Wakefulness in Patients With Narcolepsy Type 2 and Idiopathic Hypersomnia • PR Newswire (US) • 04/09/2024 11:00:00 AM
Greenlite Ventures Completes Agreement with No Limit Technology • GRNL • Jul 19, 2024 10:00 AM
VAYK Expects Revenue from First Airbnb Property Starting from August • VAYK • Jul 18, 2024 9:00 AM
North Bay Resources Acquires Mt. Vernon Gold Mine, Sierra County, California, with Assays up to 4.8 oz. Au per Ton • NBRI • Jul 18, 2024 9:00 AM
Nightfood Holdings Signs Letter of Intent for All-Stock Acquisition of CarryOutSupplies.com • NGTF • Jul 17, 2024 1:00 PM
Kona Gold Beverages Reaches Out to Largest Debt Holder for Debt Purchase Negotiation • KGKG • Jul 17, 2024 9:00 AM
Avant Technologies Welcomes Back Former CEO with Eye Toward Future Growth and Expansion • AVAI • Jul 17, 2024 8:00 AM