AbbVie touts positive cariprazine data in major depressive disorder

The schizophrenia and bipolar drug cariprazine (Vraylar) fared well as an adjunctive therapy in the Phase 3 3111-301-001 study involving patients with major depressive disorder (MDD).

AbbVie (NYSE:ABBV) is aiming to win a new FDA indication for the drug as an adjunctive treatment of MDD by the end of the year.

According to MedPage Today, 44% of patients in the 1.5-mg arm had at least a 50% reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) score by week 2 of treatment.

The company did not divulge significant data in a news release, stating that patients receiving a 1.5mg/day dose of the drug met the primary endpoint of statistically significant improvement based on the MADRS at week six compared to placebo. Patients receiving 3.0 mg/day per day had an improved MADRS total score, but the results were not statistically significant.

Patients in the 1.5 mg group also saw improvements in their scores on the Hamilton Depression Rating Sc…

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European regulators approve Janssen’s twice-yearly schizophrenia treatment

Two months after receiving a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), Janssen has won approval from the European Commission for Byannli, a six-month formulation of paliperidone palmitate.

Indicated as a maintenance treatment for adults with schizophrenia, Byannli won approval based on results from the Route 6 study, which found that 92.5% of patients receiving the therapy were relapse-free at 12 months.

The Phase 3 study was a randomized, double-blind, non-inferiority trial including 702 adults with schizophrenia.

The drug won FDA approval in September, but its trade name in the U.S. is Invega Hafyera.

To be eligible for the drug, patients must be clinically stable on either once-monthly paliperidone palmitate (PP1M) or three-monthly paliperidone palmitate (PP3M).

Janssen formulated the drug to have exceptionally low water solubility, enabling it to offer continuous absorption over six months.

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Janssen shares data on 6-month schizophrenia shot at ECNP

At the European College of Neuropsychopharmacology (ECNP), Janssen presented data on the Phase 3 trial for the recently approved schizophrenia treatment Invega Hafyera, paliperidone palmitate 6-month (PP6M).

“We hope that this continues to change the paradigm in treating schizophrenia with long-acting injectables,” said Dean Najarian, associate field director, neuroscience medical affairs at Janssen. “Non-adherence is a major contributor of relapses and associated hospitalizations, and certainly costly to the healthcare systems as well as social dynamics.”

The prospect of a six-month schizophrenia injection can “offer patients and caregivers the potential for a life less defined by their schizophrenia medication,” Najarian said.

Invega Hafyera is the only twice-yearly, long-acting injectable.

Janssen, a subsidiary of Johnson & Johnson (NYSE:JNJ), announced the FDA approval of the formulation on Sept. 1. Approvals in other countries are pending…

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