The FDA approval of a 34mg Nuplazid capsule formulation will meet the recommended daily dose in a single small capsule versus the current administration of two 17mg tablets.
In addition, the FDA approval of a 10 mg tablet provides an optimized lower dosage strength in those patients who are concomitantly receiving strong cytochrome 3A4 inhibitors which can inhibit the metabolism of Nuplazid.
Nuplazid is a non-dopaminergic, selective serotonin inverse agonist preferentially targeting 5-HT2A receptors that are thought to play an important role in Parkinson's disease psychosis. Acadia discovered and developed this new chemical entity and holds worldwide rights to develop and commercialize Nuplazid.
Acadia is a biopharmaceutical company focused on the development and commercialisation of innovative medicines to address unmet medical needs in central nervous system disorders.
Hikma announces Health Canada approval of KLOXXADO Nasal Spray for opioid overdose treatment
Plus Therapeutics secures FDA Orphan Drug Designation for Rhenium (186Re) Obisbemeda
Latigo Biotherapeutics' LTG-001 receives US FDA Fast Track designation
GenSight Biologics reports positive five-year resultsfor LUMEVOQ gene therapy
Bain Capital to acquire Mitsubishi Tanabe Pharma in USD3.3bn deal
Innovent and ASK Pharm's limertinib NDA receives Chinese regulatory approval
Anavex reports positive long-term data for blarcamesine in early Alzheimer's disease
Johnson & Johnson agrees acquisition of Intra-Cellular Therapies Inc
Neuraxpharm acquires Provigil and Nuvigil to expand CNS portfolio
Nuvation Bio secures NMPA approval for taletrectinib in China
JCR Pharmaceuticals and Modalis Therapeutics advance to next phase of joint gene therapy research
PTC Therapeutics submits vatiquinone NDA to US FDA
Mitsubishi Tanabe Pharma forms research collaboration with Dewpoint Therapeutics
IXICO signs commercial agreement with PETNET Solutions to enhance neuroimaging capabilities