Cariprazine Demonstrated Efficacy in Bipolar Depression and Concurrent Manic Symptoms Interview with:

Dr. Stephen Stahl MD PhDProfessor of Psychiatry University of California San Diego

Dr. Stahl

Dr. Stephen Stahl MD PhD
Professor of Psychiatry
University of California San Diego What is the background for this study? How does cariprazine differ from other medications for bipolar depression? It is important to note that cariprazine, a dopamine D3-preferring D3/D2 receptor and serotonin 5-HT1A receptor partial agonist, is approved for the treatment of schizophrenia (1.5-6 mg/d) and bipolar mania (3-6 mg/d) in adults. It is not yet approved for depressive episodes related to bipolar I disorder (bipolar depression).

In these data that focus on the investigational use for the treatment of bipolar depression, cariprazine has demonstrated efficacy vs placebo (PBO) in 3 phase 2/3 studies of patients with bipolar depression (NCT01396447, NCT02670538, NCT02670551). These analyses investigated the efficacy of cariprazine in patients with bipolar depression and concurrent manic symptoms (mixed features).  Continue reading

Phase 3 Trial of Cariprazine (Vraylar) Shows Promise in Bipolar Depression Interview with:

Dr. C. David Nicholson, PhD Chief R&D Officer  Allergan

Dr. C. David Nicholson

Dr. C. David Nicholson, PhD
Chief R&D Officer
Allergan What is the background for this data milestone? 

Response: Bipolar I depression refers to the depressive episodes of bipolar I disorder, the overarching brain and behavioral disorder. People with bipolar I disorder can have manic and depressive episodes, as well as mixed episodes that feature both manic and depressive symptoms at the same time. Bipolar I depression typically lasts at least two weeks, and can be difficult to differentiate from major depression during diagnosis.

Once diagnosed, treating bipolar depression can be difficult given the few therapies available to manage these symptoms of bipolar I disorder. Additionally, patients with bipolar disorder may experience shifts from depression to mania or mania to depression as well as mixed states. More treatment options are needed so that physicians can find a therapy that will treat bipolar depression effectively, while also addressing the myriad of other symptoms that patients can experience.

Cariprazine is already approved for the treatment of mania and mixed episodes. With this new data, we have the potential to also treat bipolar depression, effectively addressing the full spectrum of symptoms associated with bipolar I disorder with just one medication.

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Does Restasis Work For Dry Eye Disease? Interview with:
Steven Woloshin, MD MS

Steven Woloshin, MD Professor of The Dartmouth Institute Professor of Medicine Professor of Community and Family Medicine

Dr. Steven Woloshin

Professor of The Dartmouth Institute
Professor of Medicine
Professor of Community and Family Medicine
The Center for Medicine in the Media
Dartmouth Institute for Health Policy and Clinical Practice
Lebanon, New Hampshire What is the background for this study? What are the main findings?

Response: There has been a lot of debate about the legal maneuvers (ie, transferring patents to the Mohawk Indians) Allergan has employed to delay marketing of generic alternatives to Restasis (cyclosporine ophthalmic emulsion 0.05%).   But there is a more fundamental question that has received little attention:  Does Restasis work?  It is not approved in the European Union, Australia or New Zealand where registration applications were “withdrawn prior to approval due to insufficient evidence of efficacy” in 2001.   Although Canada approved Restasis, its national health technology assessment unit, unconvinced of meaningful benefit, recommended Canada not pay for it – according to our research, no Canadian provincial or federal drug plan currently does.   Nevertheless, Americans have spent $8.8 billion in total sales between 2009 and 2015 on Restasis, including over $2.9 billion in public monies through Medicare Part D.

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Positive Topline Results from Phase 3 Study of Cariprazine for the Treatment of Bipolar I Depression Interview with:
Gary Sachs, MD
Associate Clinical Professor of Psychiatry
Harvard Medical School What is the background for this data milestone?

Response: Bipolar disorder affects about 5.7 million adults in the United States.  It is a common, often disabling condition in which abnormal mood states impair a person’s ability to carry out everyday tasks. Bipolar disorder touches nearly every family and community in America, because periods of illness, a patient’s symptoms often impact their family, their friends, and their community.

There are a limited number of products approved to treat bipolar depression and even fewer products that have been studied and approved to treat the full spectrum of bipolar disorder, from mania through depression. Having another product proven to treat the full range of bipolar disorder would be a welcome addition to the treatment options currently available to the psychiatry community and patients.

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Allergan’s VRAYLAR (carprazine) Receives FDA Approval For Maintenance Treatment of Schizophrenia Interview with:

Dr. David Nicholson PhD EVP and Chief R&D Officer Allergan

Dr. Nicholson

Dr. David Nicholson PhD
EVP and Chief R&D Officer

Discusses Allergan’s announcement that:
New Data Shows Long-Term VRAYLAR Therapy Delayed Time to Relapse Compared to Placebo Over the Course of up to 72 Weeks and has received FDA approval for the Maintenance Treatment of Schizophrenia What is the background for this FDA approval?

Response: As many clinicians know, schizophrenia is among one of the most challenging mental health disorders to manage – due to the complexity of patient symptoms, varying response to treatment and high rates of relapse. Schizophrenia requires long-term medication management, and without maintenance treatment, 60 – 70% of schizophrenia patients relapse within one year.

The approval of Vraylar (carprazine) for the maintenance treatment of schizophrenia was based upon the results of a clinical trial, which found long-term cariprazine therapy delayed time to relapse compared to placebo over the course of up to 72 weeks. What does this extended indication mean for people living with schizophrenia? 

Response: Schizophrenia affects about 2.4 million American adults, and there remains serious unmet needs in the treatment of schizophrenia. The differences in how patients with schizophrenia respond to treatment underscore the importance of having more treatment options available. With its proven efficacy and well-characterized safety profile, cariprazine provides another treatment option for patients and clinicians. This study demonstrates cariprazine efficacy in the long-term (i.e., maintenance) treatment of schizophrenia. What should readers take away from this announcement?

Response: As a chronic disease and disabling disorder, schizophrenia requires long-term medication management. Cariprazine is a safe and effective treatment for schizophrenia in both the short and long-term management of the illness. Is there anything else you would like to add about this FDA approval and what it means for the mental health community?

Response: On behalf of Allergan as Chief Research & Development Officer at the company, we are pleased that the FDA has recognized the benefits of cariprazine for maintenance treatment of adults with schizophrenia. This approval demonstrates our continued investment in cariprazine, as well as our commitment to developing treatments that address unmet needs facing people living with mental illness. Additionally, VRAYLAR is also approved in the U.S. in adults for the acute treatment of schizophrenia and acute treatment of manic or mixed episodes of bipolar I disorder.

David Nicholson is the Chief R&D Officer, and has served in this role since March 2015. Dr. Nicholson joined the company (then Actavis) as Senior Vice President, Global Brands R&D in August 2014. He has been in research and development in the pharmaceutical industry since 1978.

Previously, he served as Chief Technology Officer and EVP, R&D for Bayer CropScience from March 2012 to August 2014; Senior Vice President of Licensing and Knowledge Management at Merck from 2009 to December 2011; and Senior Vice President, responsible for Global Project Management and Drug Safety at Schering-Plough from 2007 to 2009. From 1988 to 2007, Dr. Nicholson held various leadership positions at Organon, where he most recently served as Executive Vice President, R&D and was a member of the company’s Executive Management Committee.

Dr. Nicholson earned his B.Sc. from the University of Manchester and his Ph.D. from the University of Wales. Thank you for your contribution to the community.


Allergan Receives FDA Approval For Use of VRAYLAR™ (cariprazine) in the Maintenance Treatment of Schizophrenia

Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.