FDA Issues Refusal to File Letter in Response to New Schizophrenia Drug
The FDA stated that its preliminary appraisal found the sNDA not sufficiently complete to permit a substantive review.
The Food and Drug Administration (FDA) has issued a Refusal to File (RTF) letter in response to Allergan's Supplemental New Drug Application (sNDA) for Vraylar (cariprazine).
Vraylar, a once-daily oral atypical antipsychotic, is approved for the treatment of schizophrenia and manic or mixed episodes associated with bipolar I disorder. The sNDA proposed Vraylar as treatment of negative symptoms (ie, loss of motivation, social withdrawal, anhedonia) associated with schizophrenia in adult patients.
In the letter, the FDA stated that its preliminary appraisal found the sNDA not sufficiently complete to permit a substantive review.
“We are disappointed with the FDA decision on our submission. We will request a meeting with FDA to discuss and determine our next steps,” said David Nicholson, PhD, chief R&D officer, Allergan.
Pharmacodynamic studies of cariprazine have shown that it acts as a partial agonist at dopamine D3 and dopamine D2 receptors, and has a high binding affinity at the serotonin 5-HT1A receptor. Its exact mechanism of action in schizophrenia and bipolar I disorder is unknown.
Vraylar is available as 1.5mg, 3mg, 4.5mg, and 6mg strength capsules in 30- and 90-count bottles as well as 7-count blister packs.
Allergen receives refusal to file letter from FDA for Vraylar® (cariprazine) supplemental new drug application (sNDA) for the treatment of negative symptoms in schizophrenia [press release]. Dublin: Allergen. https://www.allergan.com/news/news/thomson-reuters/allergan-receives-refusal-to-file-letter-from-fda. Published September 22, 2017. Accessed Septmeber 28, 2017.