麻豆传媒

The FDA approved a new extended-release injectable suspension for treating schizophrenia in adults, Luye Pharma announced.

An atypical antipsychotic, paliperidone palmitate is also indicated for schizoaffective disorder in adults, as a monotherapy or adjunct to mood stabilizers or antidepressants. Injections must be administered by a healthcare provider.

"Using long-acting injectable (LAI) antipsychotics is effective in improving patient adherence, as they can reduce the dosing frequency and can also reduce the risk of patients not adhering to their dosing regimen without the knowledge of their healthcare providers," the company said.

Like other atypical antipsychotics, the labeling for paliperidone palmitate warns of increased mortality in elderly patients with dementia-related psychosis.

This marks the second injectable paliperidone palmitate product to win FDA approval. Janssen's monthly injectable formulation (Invega Sustenna) landed approval back in 2009, which was followed by 3-month () and 6-month () versions.

Underpinning Erzofri's approval was a 281-patient open-label randomized study that compared multiple doses of the newly approved injectable with Janssen's monthly product. The open-label trial showed comparable bioavailability levels within the first week of treatment. Safety was also comparable between the two agents, with no unexpected treatment-emergent adverse events.

One advantage between the two monthly paliperidone palmitate products is the new formulation does not require an additional injection on day 8 after the first injection, meaning it "could be more convenient to administer and improve patient compliance by optimizing the initial dosing regimen," Luye Pharma .

The most common adverse events (at least 5%) in trials of paliperidone palmitate included injection site reactions, somnolence/sedation, dizziness, akathisia, and extrapyramidal disorder. The drug is contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone (Risperdal, Rykindo).

Other warnings and precautions listed in the include cerebrovascular adverse reactions in elderly patients with dementia-related psychosis, neuroleptic malignant syndrome, QT prolongation, tardive dyskinesia, metabolic changes, orthostatic hypotension and syncope, and falls.

Use of a strong inducer of CYP3A4 and/or P-glycoprotein during a dosing interval should be avoided. "If concomitant use is necessary, consider using paliperidone extended-release tablets," the label notes.

The initial intramuscular injection (351 mg) of the new paliperidone palmitate product should be administered in the deltoid muscle. Subsequent monthly injections can be administered into either the gluteal or deltoid muscle, with doses ranging from 39 mg to a maximum 234 mg for schizophrenia and 78 mg to a maximum 234 mg for schizoaffective disorder.

Patients that have never been treated with oral or injectable paliperidone or risperidone should first establish tolerability with an oral form of either prior to starting the new injectable product.

Comment