Trial Outcomes & Findings for A Long Term Study of ALKS 5461 in the Treatment of Refractory Major Depressive Disorder (MDD) (NCT NCT03610048)

Last Updated: 2021-07-16

Results Overview

Number and percentage of subjects experiencing TEAEs

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

175 participants

Primary outcome timeframe

Up to 68 weeks

Results posted on

2021-07-16

Subjects that had completed the 12-week treatment period in the antecedent study ALK5461-217 were eligible to be enrolled in the study.

A total of 175 patients were administered at least one dose of ALKS 5461 and included in the safety population.

Participant milestones
Measure	ALKS 5461 All subjects assigned to ALKS 5461 Sublingual tablets ALKS 5461: samidorphan + buprenorphine administered sublingually
Overall Study STARTED	175
Overall Study Completed Treatment	15
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	161

Reasons for withdrawal
Measure	ALKS 5461 All subjects assigned to ALKS 5461 Sublingual tablets ALKS 5461: samidorphan + buprenorphine administered sublingually
Overall Study Study terminated by sponsor	84
Overall Study Adverse Event	32
Overall Study Withdrawal by Subject	31
Overall Study Lost to Follow-up	8
Overall Study Other	4
Overall Study Physician Decision	1
Overall Study Pregnancy	1

A Long Term Study of ALKS 5461 in the Treatment of Refractory Major Depressive Disorder (MDD)

Baseline characteristics by cohort
Measure	ALKS 5461 n=175 Participants All subjects assigned to ALKS 5461 Sublingual tablets ALKS 5461: samidorphan + buprenorphine administered sublingually
Age, Continuous	44.9 years STANDARD_DEVIATION 12.87 • n=5 Participants
Age, Customized <55 years	127 Participants n=5 Participants
Age, Customized >=55 years	48 Participants n=5 Participants
Sex: Female, Male Female	122 Participants n=5 Participants
Sex: Female, Male Male	53 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	151 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	19 Participants n=5 Participants
Race (NIH/OMB) White	148 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	142 participants n=5 Participants
Region of Enrollment Australia	23 participants n=5 Participants
Region of Enrollment Puerto Rico	10 participants n=5 Participants

Timeframe: Up to 68 weeks

Number and percentage of subjects experiencing TEAEs

Outcome measures
Measure	ALKS 5461 n=175 Participants All subjects assigned to ALKS 5461 Sublingual tablets ALKS 5461: samidorphan + buprenorphine administered sublingually
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)	108 Participants

Serious events: 4 serious events

Other events: 85 other events

Deaths: 0 deaths

Serious adverse events
Measure	ALKS 5461 n=175 participants at risk All subjects assigned to ALKS 5461 Sublingual tablets ALKS 5461: samidorphan + buprenorphine administered sublingually
Gastrointestinal disorders Vomiting	0.57% 1/175 • 90 weeks
Hepatobiliary disorders Bile duct stone	0.57% 1/175 • 90 weeks
Infections and infestations Gastroenteritis	0.57% 1/175 • 90 weeks
Musculoskeletal and connective tissue disorders Osteoarthritis	0.57% 1/175 • 90 weeks

Other adverse events
Measure	ALKS 5461 n=175 participants at risk All subjects assigned to ALKS 5461 Sublingual tablets ALKS 5461: samidorphan + buprenorphine administered sublingually
Gastrointestinal disorders Nausea	20.6% 36/175 • 90 weeks
Gastrointestinal disorders Constipation	9.7% 17/175 • 90 weeks
Gastrointestinal disorders Vomiting	9.1% 16/175 • 90 weeks
Gastrointestinal disorders Dry mouth	4.6% 8/175 • 90 weeks
Gastrointestinal disorders Abdominal pain upper	2.3% 4/175 • 90 weeks
Nervous system disorders Dizziness	12.0% 21/175 • 90 weeks
Nervous system disorders Headache	6.9% 12/175 • 90 weeks
Nervous system disorders Sedation	6.9% 12/175 • 90 weeks
Nervous system disorders Somnolence	5.1% 9/175 • 90 weeks
Nervous system disorders Dysgeusia	3.4% 6/175 • 90 weeks
Infections and infestations Upper respiratory tract infection	5.7% 10/175 • 90 weeks
Infections and infestations Urinary tract infection	4.0% 7/175 • 90 weeks
Infections and infestations Nasopharyngitis	2.9% 5/175 • 90 weeks
Psychiatric disorders Insomnia	4.0% 7/175 • 90 weeks
General disorders Fatigue	3.4% 6/175 • 90 weeks
Skin and subcutaneous tissue disorders Hyperhidrosis	3.4% 6/175 • 90 weeks
Ear and labyrinth disorders Vertigo	2.3% 4/175 • 90 weeks

Alkermes

Phone: 781-609-7000