results from the international, randomized, double-blind, placebo-controlled study 008A that evaluated the efficacy and safety of evenamide (30 mg bid) as add-on treatment in 291 patients not benefitting from their second-generation antipsychotic medication, including clozapine.
In the study, the addition of 30 mg (bid) of evenamide to the patients’ current antipsychotic medication was very well tolerated, with a similar profile to placebo with no increases in EPS, weight gain, blood glucose, metabolic syndrome, sexual dysfunction, CNS or cardiac effects, or laboratory abnormalities.
This summary provides an overview of the additional data presented by Newron Pharmaceuticals, highlighting the potential of Evenamide as a treatment for schizophrenia patients who have an inadequate response to existing medications.
Like I am on two APs (Abilify plus Amisulpride), but a responder to this combination and mostly have no symptoms.
In this case, might Evenamide work for me? I mean I am not treatment resistant, but responsd adequately to the current combination. However, I have side effects, and to change Amisulpride with Evenamide which seems to have no serious side effects seems to be the logical choice.
I guess, what I mean is that they are testing on a very specific subset of people, who are classified as treatment resistant. But, how exactly are they defining treatment-resistance? Like, would I qualify as a potential responder to Evenamide, would you know?
The 008A study was on patients who weren’t adequately responding to their AP but weren’t necessarily treatment resistant. So like most of us these patients were somewhat stable but not functioning well.
I was like you on Amisulpride and substitute this in the Phase II study with Evenamide. The trial took place in Cagliari and i was overwhelmed by the massiv possitiv effect. More over the heavy side effects i had befor was with Evenamide completely gone. As all goes so well i am continuing to take 2 times a day 30mg Evenamide.
How they really measure treatment resistent i dont know. But I was kind of stucked with every mix of availability medicaments. Today i feel as a new human. I feel my daily life is so much better and i see for me personally almost a Healing.
My hallucinations became less intense. The voices that tormented me gradually faded. The world around me began to become clearer. I could laugh again without feeling guilty.
I also had much less dizziness than with alternative medication.
And, amazingly, my sexual desire returned. I don’t know whether this is due to fewer side effects or because I felt more fully human again.
That’s amazing! I’m so happy for you! I really hope they have a trial for it in the U.S. you wouldn’t happen to have any insight on where there planning to do phase 3 would you?
As I understand it, North America will be included in the clinical trial, although it’s unclear whether this specifically refers to the United States. The trial aims to recruit over 500 patients for phase III, potentially granting even more individuals access to this new treatment. Given my positive experience with Evenamide, I sincerely hope that health administrations expedite the approval process for this promising medication.
It seems like from what you’ve said Evenamide is helping your negative symptoms? Is that correct? Were negative symptoms ever a big problem for you? Also has it helped your cognition at all? I don’t mean to pester you. I’m just extremely excited for this drug.
If I remember correctly 25% of the patients they treated in phase 2 with this drug actually entered remission. Seems like this might be the miracle med we’ve all been waiting for.
In the past, I struggled significantly with social interactions, although I wasn’t certain if this was also related to my Borderline diagnosis. My mood could plummet rapidly. However, today, I sense improvements in achieving a healthier balance. Social interactions feel more positive, and the intense feeling of being attacked has diminished. I find myself understanding situations more clearly and responding appropriately.
It’s such a relief, I went through hell and those around me with me. I don’t know how people were able to switch off with me. I’m just grateful that this time is in the past.
