Alkermes Gets FDA OK of Lybalvi for Schizophrenia, Bipolar I Disorder >ALKS

the drug, which is a once-daily, oral antipsychotic composed of the established antipsychotic agent olanzapine and samidorphan, a new chemical entity.


I’m curious about how much less weight gain there is with this med compared to olanzapine on its own


Interesting that it’s combined with an opioid


Wow… I’ll be seriously considering trying this new AP.

I’ve been waiting for it for a while.

Thanks for the info @everhopeful


Approval of olanzapine-samidorphan carries opioid-related contraindications
The FDA approved the antipsychotic combination of olanzapine plus samidorphan (Lybalvi) for adults with schizophrenia or bipolar I disorder, drugmaker Alkermes announced on Tuesday.

In schizophrenia, olanzapine-samidorphan is indicated as a monotherapy; in bipolar I disorder, the drug is approved as either a maintenance monotherapy or for the acute treatment of manic or mixed episodes as an adjunct to lithium or valproate.

The once-daily, oral treatment combines the atypical antipsychotic olanzapine (Zyprexa), which has been approved since 1996 as monotherapy. However, the major drawback with olanzapine alone is its association with substantial weight gain.
Offsetting this, the novel mu-opioid antagonist samidorphan, which has never been approved alone, was able to significantly reduce weight gain in patients while maintaining the efficacy of the antipsychotic.

Labeling for the drug will hold a warning on increased mortality in elderly patients with dementia-related psychosis and will be contraindicated for patients using opioids or currently undergoing opioid withdrawal.

Olanzapine-samidorphan will be formulated in fixed-dosage strengths composed of 10 mg for samidorphan, and 5 mg, 10 mg, 15 mg, and 20 mg for olanzapine.

The approval comes based on the ENLIGHTEN clinical program, which last fall swayed an FDA advisory committee to recommend the combination for approval, garnering a favorable vote of 11-6. While the panel was encouraged by the antipsychotic efficacy, some concerns still lingered over risks associated with the opioid antagonist component of the agent.

The phase III program found a significant reduction in Positive and Negative Syndrome Scale scores and improvement in the Clinical Global Impression-Severity scale when compared with placebo, along with far less weight gain than olanzapine alone.
“Samidorphan is believed to limit the pleasure of food intake that has been enhanced by olanzapine,” ENLIGHTEN-2 lead investigator Joseph McEvoy, MD, of Augusta University in Georgia and Duke University Medical Center in Durham, North Carolina, previously told MedPage Today . “Olanzapine is the most efficacious non-clozapine antipsychotic medication, and we want to be able to use it more, while managing its adverse effects. This study demonstrates a helpful mechanism to be able to do that.”

The announcement by Alkermes stated that it expects the new antipsychotic to be available in the U.S. in the fourth quarter of 2021.


I’m really happy this got approved, but one sentence sticks out for me: “Samidorphan is believed to limit the pleasure of food intake that has been enhanced by olanzapine”
My question would be, does it only limit the pleasure of eating? I was hoping it prevented weight gain while letting us eat more food, perhaps by not letting the olanzapine slow down the metabolism as much, or something like that… I was hoping for something to that effect.
I’m taking olanzapine and my appetite isn’t increased because of it. So for me, the way I understand it, the drug wouldn’t have any benefits over regular olanzapine.
Maybe I’m wrong on this? I hope I am. I must read up on what exactly this samidorphan does


I might keep an eye on this one.

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But to be honest about it I was on 7.5mg of olanzapine and it really didn’t help so much.

I don’t know if my doctor would want me off the Risperdal to try this drug that may or may not work for me.

I wonder if this drug raises blood sugar levels like plain old olanzapine does?

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As someone who likes Zyprexa for positives I find this interesting.

Good one dude!

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Zyprexa did not work for my positive symptoms.


It gave me akathisia, which is supposedly a very rare occurrence with zyprexa


I also gained 85lbs on it in 6 months