The pooled population comprised 1073 patients with an acute exacerbation of schizophrenia randomized to placebo (n = 412), lumateperone 42 mg (n = 406) or risperidone 4 mg (n = 255). Treatment-emergent adverse events (TEAEs) were predominantly mild and rates of discontinuation due to TEAEs with lumateperone 42 mg (0.5%) were similar to placebo (0.5%) and lower than risperidone (4.7%). The only TEAEs that occurred at a rate of ≥5% and twice placebo for lumateperone were somnolence/sedation and dry mouth. Mean change from baseline in metabolic parameters and prolactin were similar to or reduced in lumateperone 42 mg relative to placebo-treated patients and were smaller than risperidone. Mean change in weight and rates of extrapyramidal symptoms-related TEAEs were similar for lumateperone 42 mg and placebo-treated patients and less than for risperidone-treated patients. This pooled analysis demonstrates the safety and favorable tolerability profile of lumateperone 42 mg.
To put it more simply, adverse events that resulted in discontinuation of the medication were about the same in lumateperone and placebo. More people in the risperidone group had adverse events than in either the placebo or lumateperone group.
More people in the lumateperone group had sleepiness and dry mouth than in the placebo group.
Metabolic measures, weight, EPS related adverse events and prolactin were similar in lumateperone and placebo.
And they did convince the FDA that one of the sites had a problem with the placebo response, but not the others. I think it would have been different if they found that the placebo response was elevated across all the study sites.
I got tired of waiting for the boffins to invent better drugs so decided to go the brain training route instead. Brain training is available right now and the new drugs may or may not come.
It’s like the old nightclub meme, ‘Go ugly straight away and you’ll succeed’. Waiting for some beauty to land on your lap is a serious gamble.
Lumateperone (lumateperone tosylate, ITI-007) is a mechanistically novel investigational agent for schizophrenia.9 The mechanism of action of lumateperone is unique because it simultaneously modulates serotonin, dopamine, and glutamate neurotransmission, the key neurotransmitters implicated in serious mental illness.9 Specifically, lumateperone acts as a potent serotonin 5-HT2A receptor antagonist, a dopamine D2 receptor presynaptic partial agonist and postsynaptic antagonist,10 a D1 receptor–dependent modulator of glutamate, and a serotonin reuptake inhibitor.9 In addition, lumateperone lacks interaction with off-target receptors that may contribute to the adverse effects of other antipsychotic drugs.
