Key Takeaways
- The FDA has paused U.S. enrollment in Newron Pharmaceuticals’ schizophrenia trial after a patient’s death abroad.
- The independent safety monitoring board decided the trial could proceed, linking the death to underlying conditions rather than the treatment.
- Newron continues other trials for evenamide, which has shown promise in previous studies despite regulatory setbacks.
FDA Halts Enrollment in Newron’s Schizophrenia Trial
The FDA has suspended U.S. enrollment in Newron Pharmaceuticals’ phase 3 study of evenamide, a treatment for patients with treatment-resistant schizophrenia. This action follows the sudden death of a patient outside the U.S. in April, although Newron has clarified that the incident was not attributed to the treatment.
The ENIGMA-TRS 2 study aims to include approximately 400 patients across the U.S., Argentina, India, and several other countries. Upon notifying the independent safety monitoring board of the death, the board concluded that the trial should continue unchanged. Newron’s Chief Medical Officer, Dr. Ravi Anand, emphasized that there is no increased risk of mortality associated with evenamide compared to placebo, and noted that sudden deaths can occur among patients with schizophrenia for various reasons.
Research indicates that individuals with schizophrenia have a heightened risk of sudden death, which could be due to several factors including heart attacks, pneumonia, or airway obstruction.
Additionally, Newron is engaged in another phase 3 trial, ENIGMA-TRS 1, which is currently recruiting patients in Europe, Canada, and parts of Asia. The company is optimistic about the development program for evenamide, stating that patient safety remains a top priority and no related mortality increase has been observed thus far.
In a related business development, Newron licensed some rights to evenamide in Asia to EA Pharma, a subsidiary of Eisai, which is set to develop and market the drug in Japan and other Asian markets. This agreement was established in late 2024 for an upfront payment of $46.1 million.
While Newron previously reported promising results from a phase 2/3 study in 2024, securing approval for evenamide would position it as a significant new treatment option for schizophrenia. However, the company faced stiff competition, losing the race to Bristol Myers Squibb, which received approval for Cobenfy through a substantial $14 billion acquisition of Karuna Therapeutics.
The ongoing challenges in drug development highlight the complexities of bringing new schizophrenia treatments to market amidst safety concerns, competitive pressures, and regulatory scrutiny. Newron Pharmaceuticals aims to navigate these hurdles as it continues its research initiatives to improve outcomes for patients with mental health disorders.
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