Posted by SLS on December 17, 2013, at 9:06:09
In reply to Cariprazine - A better Abilify?, posted by SLS on October 21, 2013, at 13:31:14
> Cariprazine is an investigational antipsychotic with antidepressant properties. It is a DA receptor partial agonist, as is Abilify, but is preferential for D3 receptors. It is D2 antagonism that is most responsible for prolactin release and weight gain. Therefore, cariprazine should be weight-neutral compared to Abilify, and perhaps less apt to produce diabetes.
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> I'll be first in line to try this drug.
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> - Scott
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> "Forest has filed New Drug Applications (NDAs) with the U.S. Food and Drug Administration (FDA) for cariprazine for the treatment of schizophrenia and manic or mixed episodes associated with bipolar I disorder. Cariprazine is an orally active and potent dopamine D3-preferring D3 /D2 receptor partial agonist. Cariprazine has a low affinity at other receptor sites such as 5-HT2C, muscarinic, and adrenergic which have been associated with adverse events. Cariprazine is also under development as an adjunctive treatment for MDD and for the treatment of bipolar depression. Cariprazine was discovered by Gedeon Richter Plc and is licensed to Forest Laboratories Inc., in the U.S. and Canada." - Business Wire
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Cariprazine update:
----------------------------------------------http://www.reuters.com/article/2013/11/21/forest-richter-idUSL5N0J625E20131121
"UPDATE 1-FDA declines to approve new Forest, Richter psychosis drug
Thu Nov 21, 2013 5:49am EST
0 Comments* FDA issues complete response letter for cariprazine
* Move set to delay launch of antipsychotic drug in U.S.
* Richter shares fall 2.8 percent
BUDAPEST, Nov 21 (Reuters) - U.S. health regulators have declined to approve a new antipsychotic drug from Forest Laboratories and Richter, citing the need for more information, including likely additional clinical trial data.
The Food and Drug Administration (FDA) delivered its verdict on cariprazine for schizophrenia and bipolar disorder in a so-called "complete response letter," the type of letter issued by the agency to convey that it cannot approve a drug application in its current form.
Cariprazine was discovered by Hungarian drugmaker Richter and licensed to Forest in the United States and Canada.
Industry analysts have forecast North American sales of the drug of $250 million in 2017, according to consensus forecasts compiled by Thomson Reuters Pharma.
In its letter the FDA acknowledged that cariprazine demonstrated effectiveness but the two companies said on Thursday it appeared regulators wanted more tests on the optimal dose of the treatment to avoid potential side effects.
"This is likely to cause a delay ... (but) we cannot tell how much; we will be able to tell after consultations with the FDA," said Richter spokeswoman Zsuzsa Beke.
The companies said that the FDA had indicated that its request for more information included the need for additional clinical trial data. But Beke said it was possible this might not turn out to be necessary.
"Whether we need more clinical tests, we can also tell that after the consultations - it is possible that the existing data will be sufficient," she said.
Richter's shares were down 2.8 percent by 1040 GMT."
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- ScottSome see things as they are and ask why.
I dream of things that never were and ask why not.- George Bernard Shaw
poster:SLS
thread:1052699
URL: http://www.dr-bob.org/babble/20131209/msgs/1056417.html