Lybalvi(ALKS 3831)
Psychiatry· 669 cited findings· 1 source document
Company: Alkermes plc →
What the regulatory reviews say
Lybalvi (ALKS 3831) is a drug reviewed for its efficacy and safety. Efficacy findings indicate a least squares (LS) mean difference from placebo in PANSS total score of -6.4. Another efficacy measure showed a PANSS total score change from baseline of -17.5. The drug also demonstrated an LS mean difference from placebo in CGI-S of -0.38.
Safety data from a population of 2004 N subjects for ALKS 3831 development showed a total discontinuation rate due to adverse events of 10.9%, with 12.0% in the ALKS 3831 group. Mean weight change from baseline was 3.02 kg, and 25.8% of subjects experienced greater than 7% weight gain from baseline. One incident of precipitated opioid withdrawal was noted in a samidorphan-only trial.
Regulatory review included an Advisory Committee vote, with 16 Yes votes, 1 No vote, and 0 Abstain votes, on whether there was adequate evidence that samidorphan mitigates olanzapine-associated weight gain. The committee also voted on whether the applicant adequately characterized the safety profile of ALKS 3831 (13 Yes, 3 No, 1 Abstain) and if labeling was sufficient to mitigate risks related to the opioid antagonist action of samidorphan (11 Yes, 6 No).
Key figures — cited to the source page
| LS mean difference from placebo in PANSS total score | -6.4 | Alkermes plc — Lybalvi FDA Review (NDA213378, ORIG 1, 2021), p.24 |
| LS mean difference from placebo in CGI-S | -0.38 | Alkermes plc — Lybalvi FDA Review (NDA213378, ORIG 1, 2021), p.24 |
| PANSS total score change from baseline | -17.5 | Alkermes plc — Lybalvi FDA Review (NDA213378, ORIG 1, 2021), p.128 |
| Safety Population for ALKS 3831 Development | 2004 | Alkermes plc — Lybalvi FDA Review (NDA213378, ORIG 1, 2021), p.89 |
| Discontinuation due to AEs (total) | 10.9% | Alkermes plc — Lybalvi FDA Review (NDA213378, ORIG 1, 2021), p.110 |
| Mean weight change from baseline | 3.02 | Alkermes plc — Lybalvi FDA Review (NDA213378, ORIG 1, 2021), p.215 |
| Advisory Committee vote: adequate evidence samidorphan mitigates olanzapine-associated weight gain (Yes votes) | 16 | Alkermes plc — Lybalvi FDA Review (NDA213378, ORIG 1, 2021), p.35 |
| Advisory Committee vote: Applicant adequately characterized safety profile of ALKS 3831 (Yes votes) | 13 | Alkermes plc — Lybalvi FDA Review (NDA213378, ORIG 1, 2021), p.35 |
Source documents
Explore the full evidence
All 669 cited findings for Lybalvi — searchable, comparable and answerable in plain language — are in the Psychiatry research library →
Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.