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Re: FDA Approves New Atypical Antipsychotic, Caplyta

Posted by PeterMartin on December 23, 2019, at 21:58:46

In reply to FDA Approves New Atypical Antipsychotic, Caplyta, posted by PeterMartin on December 23, 2019, at 21:54:26

Seems to have mixed results (per investors). Some thought it was going to get rejected. They're also trying to get it approved for BP.

Besides schizophrenia, Intra-Cellular is also eyeing Caplyta use in other indications, such as bipolar disorder and major depressive disorder. In two phase 3 studies for major depressive episodes associated with bipolar I or bipolar II disorder, the drug also showed mixed results, as one met its primary endpoint while another missed.

The green light caps off a twisted FDA review path, which previously hinted at a possible rejection.

Caplyta beat placebo on improving schizophrenia symptom severity as measured by a metric known as the Positive and Negative Syndrome Scale in two placebo-controlled trials. But one phase 3 study, dubbed ITI-007-302 and involving 696 patients, failed back in 2016, as the drugat both the 20-mg and 60-mg dosesdidnt top placebo on the score.

Then, Intra-Cellulars stock suffered again in July when the FDA called off an advisory panel meeting, citing new information regarding the application. The company said at the time that the agency was looking at information from non-clinical studies. To investors, that cancellation was interpreted as low FDA confidence in the drugso low that it didn't even require an open discussion.

RELATED: FDA calls off AdComm for Intra-Cellular's schizophrenia prospect

To further complicate investor sentiment, the FDA in August extended its review time by three months, citing the need to look over preclinical data. However, after going through similar historical events, Jefferies analysts in November noted that most new drug applications that had decision extensions actually ended up with FDA approvals.




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