Company: LBRX
Filing Date: 2025-09-08
Form Type: S-1/A
Source: 0001193125-25-197877
Chunk: 194

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-09-08
Form: S-1/A
Chunk 194
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ulpride’s effect size compares with Cobenfy’s and the other approved schizophrenia drugs.

Amisulpride’s effect size was greater than that of Cobenfy.

128

EUFEST, a European clinical trial published in 2005 in which 498 first-episode schizophrenia
patients were randomized to receive haloperidol, amisulpride, olanzapine, quetiapine, or ziprasidone over 12 months, evaluated the primary endpoint of all-cause discontinuation rate, which is the number of
patients who stopped taking their medications for any reason. Besides olanzapine, amisulpride had the lowest all-cause discontinuation rate over 12 months out of all drugs evaluated in this head-to-head comparison, supporting a favorable tolerability profile.

Amisulpride had a low discontinuation rate in the head-to-headEUFEST trial.

129

Amisulpride has also been shown to have a relatively low rate of EPS (11%), long-term weight
gain, and cardiovascular risk compared with other second-generation antipsychotic drugs. In a 2014 head-to-head meta-analysis conducted by a third party comparing weight
gain among antipsychotics, amisulpride had lower weight gain compared with other antipsychotic drugs across various outcome measures including body weight gain (in kg). The results comparing weight gain for amisulpride with that of other
antipsychotics are highlighted in the chart below.

FGA = first generation antipsychotics; SGA = second generation antipsychotics; st= number of studies

Amisulpride had a lower weight gain compared with other antipsychotic drugs.

Additionally, in a third-party head-to-head trial completed in
2002 that compared long-term weight gain of amisulpride over six months to that of olanzapine, amisulpride weight gain exceeded that of olanzapine over the first 30 days of the study, and plateaued at approximately 1 kg, whereas weight gain with
olanzapine continued to increase throughout the six-month period reaching a weight gain of approximately 5 kg, as shown in the graph below:

Amisulpride had lower weight gain than olanzapine in a third-party head-to-headtrial.

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In addition, pharmacovigilance data on amisulpride from the United Kingdom covering 16,000
patient exposure years had 8 incidences