Polpharma API characteristics:
- Crystalline Form C, same as in innovator’s tablets (physico-chemically most stable)
- PSD tailored to FDF needs
- Good control of Impurity profile by handling 4 chemical steps in-house (2 isolated intermediates)
- Green chemistry - no phosgenation reactions
Pimavanserin tartrate acts as anti-psychotic agent.
Pimavanserin is indicated for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.
It is also under development for the treatment of hallucinations and delusions associated with dementia-related psychosis, psychosis in schizophrenia patients, Alzheimer’s disease agitation, Alzheimer’s disease psychosis (ADP), Dementia with Lewy bodies, Parkinson’s disease dementia, Vascular dementia, Frontotemporal dementia, as adjunctive treatment for the negative symptoms of Schizophrenia and Major Depressive Disorder.
It is formulated as film coated tablets for an oral route of administration.
Mechanism of action:
Pimavanserin selectively blocks the activity of the 5-HT2A receptor, a drug target that plays an important role in the treatment of various neuropsychiatric disorders. It works on the neurotransmitter serotonin, by binding with the 5-HT2A receptor.