FDA Rejects Vanda Pharmaceuticals' Fanapt for Gastroparesis
Key Insights
The FDA has declined to approve Vanda Pharmaceuticals' supplemental New Drug Application (sNDA) for Fanapt (iloperidone) in treating gastroparesis (search), a stomach condition characterized by delayed gastric emptying.
This rejection marks a setback for Vanda, which sought to expand Fanapt's indication beyond its current approval for schizophrenia (search), addressing an unmet need in gastroparesis (search) management.
The FDA's decision was based on a complete response letter (CRL), citing concerns that were not specified, but require further evaluation before potential approval.
The U.S. Food and Drug Administration (FDA) has rejected Vanda Pharmaceuticals' supplemental New Drug Application (sNDA) for Fanapt (iloperidone) for the treatment of gastroparesis (search). This setback prevents the expansion of Fanapt's use beyond its current indication for schizophrenia (search). Gastroparesis is a chronic condition characterized by delayed gastric emptying, leading to symptoms such as nausea, vomiting, abdominal pain, and bloating. The condition affects a significant portion of the population, with estimates suggesting that it impacts millions of Americans, creating a substantial unmet medical need.
The FDA issued a complete response letter (CRL) regarding the sNDA. While the specific reasons for the rejection were not disclosed in detail, the CRL indicates that the FDA requires further evaluation of the data provided by Vanda before a potential approval can be considered. This decision follows a period of review during which the FDA assessed the efficacy and safety data submitted by Vanda to support the use of Fanapt in gastroparesis (search) patients.
Fanapt is an atypical antipsychotic already approved for the treatment of schizophrenia (search). Its mechanism of action involves the blockade of dopamine and serotonin receptors in the brain. The rationale for investigating its use in gastroparesis (search) stems from the drug's potential to modulate gastrointestinal motility through its effects on neurotransmitter pathways. Clinical trials have explored Fanapt's ability to accelerate gastric emptying and alleviate symptoms associated with the condition.
Vanda Pharmaceuticals has stated that it intends to review the contents of the CRL and will work to determine the appropriate path forward. The company remains committed to pursuing solutions for patients suffering from gastroparesis (search). The rejection underscores the challenges inherent in drug development and the rigorous standards that the FDA applies when evaluating new therapies, particularly for conditions with limited treatment options.