FDA Approves Luye Pharma's ERZOFRI for Schizophrenia

The US Food and Drug Administration (FDA) has given its approval to Luye Pharma’s ERZOFRI (paliperidone palmitate) extended-release injectable suspension for treating schizophrenia in adults. This approval also applies to schizoaffective disorder in adults, allowing it to be used either as a standalone therapy or alongside mood stabilizers or antidepressants.

Schizophrenia and schizoaffective disorder are serious, long-term psychiatric conditions that frequently result in relapses. Managing these disorders often requires antipsychotic medications, which are essential for alleviating symptoms. However, maintaining consistent adherence to these treatment regimens is a common challenge among patients. Long-acting injectable (LAI) antipsychotics, such as ERZOFRI, have been demonstrated to improve patient adherence to their treatment plans.

ERZOFRI is administered monthly, which reduces the necessity for frequent dosing and minimizes the risk of patients deviating from their prescribed treatment regimen without their healthcare provider’s knowledge. This marks ERZOFRI as the first patented long-acting injection of paliperidone palmitate developed in China to gain approval in the United States. The product, which was patented in 2023 under Patent No. 11,666,573, enjoys patent protection until 2039. It received its approval as a new drug through the 505(b)(2) regulatory pathway in the US.

In the previous year, the sales of paliperidone palmitate long-acting injectables reached $2.897 billion in the US market. This latest approval of ERZOFRI aligns with a series of advancements in the pharmaceutical sector. For instance, China’s National Medical Products Administration (NMPA) recently approved Mimeixin, which is a combination of oxycodone hydrochloride and naloxone hydrochloride sustained-release tablets, for managing severe pain in adults, including cancer-related pain. Mimeixin contains naloxone, an opioid receptor antagonist that helps reduce opioid-induced constipation by preventing oxycodone from binding to opioid receptors in the gut.

The development and approval of treatments like ERZOFRI and Mimeixin highlight the ongoing efforts in the medical field to address complex health conditions with innovative therapeutic approaches. The introduction of ERZOFRI provides a significant step forward in offering more manageable and effective treatment options for individuals living with schizophrenia and schizoaffective disorder, ultimately aiming to improve their quality of life through better adherence to medication.