Looking good…
For those that don’t click:
" * No metabolic (weight gain, elevated blood sugar, increase in lipids), no endocrine (hypothyroidism, hyperprolactinemia) side effects and no increase in suicidal ideation compared to placebo."
“In addition to the suboptimal efficacy of current antipsychotic treatments, patients also suffer from side effects and poor tolerability, which include side effects such as akathisia, weight gain/obesity, diabetes, high cholesterol, hypothyroidism and sexual dysfunction. Moreover, we estimate discontinuation/non-compliance rates at 30 to 45% in the acute phase treatment and up to 74% in the long-term treatment of stable schizophrenia patients. Our phase 2 data shows that brilaroxazine potentially can mitigate the negative side effects of current treatments and ultimately that would hopefully improve patient’s compliance to the treatment.”
This is very encouraging.
I remember reading about this drug years ago and then … nothing. Like no development. It had sounded really promising and I had wondered why they seemingly abandoned it. Glad to see they did not.
The PANSS total score was reduced by 20 points, a statistically significant treatment difference from the placebo. Brilaroxazine also mitigated positive symptoms and negative symptoms, and improved social functioning and cognition. Importantly, the FDA has agreed to consider a potential ‘Superior Safety’ label claim, if there is a positive outcome on a relevant endpoint in a pivotal Phase 3 clinical study in schizophrenia.
The average reduction in PANSS from placebo is pretty similar to other atypical antipsychotics. It’s the other parts - better safety, side effects profile, improved cognition and social functioning that make it interesting.