Luye Pharma announced today that a pivotal study has started in the U.S. for the company's in-house developed innovative formulation, Paliperidone Palmitate extended-release injectable suspension (LY03010). LY03010 is one of the key investigational drugs in the company's Central Nervous System (CNS) pipeline and is indicated for the treatment of schizophrenia and schizoaffective disorders.
At the pre-IND meeting, the U.S. Food and Drug Administration (FDA) confirmed that demonstration of bioequivalence at steady state after multiple doses would be acceptable to support the 505(b)(2) New Drug Application (NDA) submission for LY03010. After the completion of two clinical studies in U.S., the clinical protocol relating to the pivotal study for LY03010 was submitted to the FDA, following which the FDA completed its review and agreed to the proposal.
LY03010 is an extended-release injectable suspension for single monthly dosage by intramuscular injection, indicated for the treatment of schizophrenia and schizoaffective disorders. Schizophrenia patients have a high rate of recurrence due to low compliance, and as a severe mental disease, this poses a major challenge to effective treatment. LY03010 can improve the often-seen compliance issues of oral antipsychotic drugs in patients with schizophrenia. Compared with other similar drugs on the market, LY03010 optimizes the initial dosing regimen and may therefore bring greater convenience to patients, increasing patient compliance.
According to the World Health Organization, schizophrenia affects more than 21 million people worldwide, and one in two people living with the disease is not receiving treatment for the condition. Schizophrenia is associated with considerable disability; people with the disease are 2-3 times more likely to die than the general population.
Remarking on the current situation, a senior spokesperson from Luye Pharma Group said “Schizophrenia not only causes serious harm to patients, but also poses a great burden to their families and the society. We are rapidly advancing with the clinical work on LY03010 and hoping to provide a new treatment option to patients as quickly as we can".
CNS diseases including schizophrenia are one of the strategic therapeutic areas of focus for Luye Pharma. The company has formed a robust product pipeline in this field, covering depression, Parkinson's Disease, bipolar disorder, Alzheimer's Disease, and others. In addition to LY03010, the company has a number of other investigational drugs already in late-stage clinical trials and the NDA phase in China, the U.S., Europe and other international markets.
Luye Pharma announced today that a pivotal study has started in the U.S. for the company's in-house developed innovative formulation, Paliperidone Palmitate extended-release injectable suspension (LY03010). LY03010 is one of the key investigational drugs in the company's Central Nervous System (CNS) pipeline and is indicated for the treatment of schizophrenia and schizoaffective disorders.
At the pre-IND meeting, the U.S. Food and Drug Administration (FDA) confirmed that demonstration of bioequivalence at steady state after multiple doses would be acceptable to support the 505(b)(2) New Drug Application (NDA) submission for LY03010. After the completion of two clinical studies in U.S., the clinical protocol relating to the pivotal study for LY03010 was submitted to the FDA, following which the FDA completed its review and agreed to the proposal.
LY03010 is an extended-release injectable suspension for single monthly dosage by intramuscular injection, indicated for the treatment of schizophrenia and schizoaffective disorders. Schizophrenia patients have a high rate of recurrence due to low compliance, and as a severe mental disease, this poses a major challenge to effective treatment. LY03010 can improve the often-seen compliance issues of oral antipsychotic drugs in patients with schizophrenia. Compared with other similar drugs on the market, LY03010 optimizes the initial dosing regimen and may therefore bring greater convenience to patients, increasing patient compliance.
According to the World Health Organization, schizophrenia affects more than 21 million people worldwide, and one in two people living with the disease is not receiving treatment for the condition. Schizophrenia is associated with considerable disability; people with the disease are 2-3 times more likely to die than the general population.
Remarking on the current situation, a senior spokesperson from Luye Pharma Group said “Schizophrenia not only causes serious harm to patients, but also poses a great burden to their families and the society. We are rapidly advancing with the clinical work on LY03010 and hoping to provide a new treatment option to patients as quickly as we can".
CNS diseases including schizophrenia are one of the strategic therapeutic areas of focus for Luye Pharma. The company has formed a robust product pipeline in this field, covering depression, Parkinson's Disease, bipolar disorder, Alzheimer's Disease, and others. In addition to LY03010, the company has a number of other investigational drugs already in late-stage clinical trials and the NDA phase in China, the U.S., Europe and other international markets.
