Forest depression candidate struggles against placebo
pharmafile | March 1, 2011 | News story | Research and Development | Forest, Forest Laboratories, Gedeon Richter, cariprazine, depression, major depressive disorder
An investigational antipsychotic drug being developed by Forest Laboratories and Budapest-based Gedeon Richter has failed to prove itself in phase II trials.
Cariprazine is being studied as a once-daily adjunctive therapy in major depressive disorder (MDD) in an eight-week study of patients who haven’t responded to at least two antidepressant therapies (ADT).
The drug is being studied at two doses and preliminary top-line results show neither dose achieved a statistically significant difference over placebo when it came to the trial’s primary endpoint of performance on the Montgomery Asberg Depression Rating Scale.
The study involved 231 patients on either low dose (0.1-0.3 mg per day cariprazine and ADT), high dose (1.0-2.0 mg per day cariprazine and ADT) or placebo plus ADT treatment arms.
The companies said there was “evidence of a treatment effect” in the high-dose arm of the study compared to placebo”, and they are considering an additional phase II dose-response trial examining a wider range of doses.
The drug, a D3/D2 partial agonist which binds to D3 receptors, is also currently in phase III trials for indications in schizophrenia and bipolar mania, where it has demonstrated a reduction in symptoms.
MDD is an attractive market for pharma firms and the potential for both companies is significant: it affects approximately 42 million people worldwide and the global antidepressant market is estimated to be worth $20 billion.
In February AstraZeneca and Targacept began a phase IIb trial of nicotinic channel blocker TC-5214 as a ‘switch’ monotherapy for MDD patients in whom initial ADT has not worked.
The companies are also carrying out a phase III study for TC-5214 as an adjunctive treatment for MDD.
Forest’s pipeline suffered a setback in November, when the COPD drug aclidinium bromide, developed with Almirall, produced fewer benefits at phase III than were found in earlier studies.
Adam Hill
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