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  It is not approved in the European Union, Australia or New Zealand where registration applications were “withdrawn prior to approval due to insufficient evidence of efficacy” in 2001.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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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.