The phase 1, multicenter, randomized, double-blind, placebo- and active-controlled study was designed to compare the mean change from baseline in body weight following three weeks of oral administration of ALKS 3831 in a study that included 106 healthy, normal-weight male volunteers. The safety and tolerability results for ALKS 3831 were overall similar to those observed with the olanzapine-only treatment group. Healthy volunteers who received ALKS 3831 gained an average of 2.5 kg (5.5 lbs), while subjects who received olanzapine alone gained an average of 3.4 kg. The difference between the ALKS 3831 treatment group and the control group receiving olanzapine alone was statistically significant over the three-week study period, with a trend indicating the potential for even greater differentiation over longer study periods.
Based on the positive results of the phase 1 study, Alkermes plans to initiate a phase 2 dose-ranging study of ALKS 3831 in mid calendar 2013.
Recent ALKS News
- Alkermes to Host Investor Event to Review Orexin Portfolio Strategy • PR Newswire (US) • 09/25/2024 12:00:00 PM
- Alkermes to Present Positive Clinical Data From Phase 1b Study of ALKS 2680 in Patients With Narcolepsy Type 2 and Idiopathic Hypersomnia at Sleep Europe 2024 • PR Newswire (US) • 09/23/2024 11:00:00 AM
- 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
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