Ploughing ahead after Phase III setback
Hungarian Gedeon Richter and Irish Allergan are staying on course in the face of dissappointing Phase III results for depression drug cariprazine. The partners will now begin another Phase III study needed for approval.
The MD72 trial evaluated cariprazine in flexible doses as an adjunctive treatment to antidepressants with Major Depressive Disorder (MDD). Results indicate that cariprazine did not perform better than placebo – a marked deterioration from earlier studies that showed significant effectiveness of the small molecule. We are disappointed with the results of this trial, said David Nicholson, Chief R&D Officer at Allergan. However, we believe that our plan to move forward with another Phase III study in Adjunctive MDD coupled with our previous positive clinical trial would provide the two studies needed for submission. This is an important next step to further develop the cariprazine programme.
Cariprazine is a dopamine receptor partial agonist. It has already been approved by the FDA for the treatment of manic or mixed episodes of Bipolar I disorder and schizophrenia and is marketed as Vraylar in the US.
It is not uncommon that clinical trials in MDD fail to show a separation from placebo even with effective drugs, the partners said in a release. Both companies remain committed to developing cariprazine as a potential treatment option for patients suffering from this serious illness and will continue to work on a subsequent Phase 3 trial.
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