|[December 12, 2013]
Retrophin to Co-Sponsor Clinical Trial of Intranasal Oxytocin for Schizophrenia
NEW YORK --(Business Wire)--
Retrophin, Inc. (OTCQB:RTRX) today announced that it has agreed to
support the completion of a Phase II clinical trial of oxytocin for the
treatment of schizophrenia directed by Dr. David Feifel, Department of
Psychiatry, University of California, San Diego. The study will become
part of the company's clinical development program for Syntocinon™.
"We look forward to collaborating with Dr. Feifel on this promising
study and taking steps toward the development of intranasal Syntocinon,"
said Martin Shkreli, Founder and Chief Executive Officer of Retrophin.
"There has been no new mechanism of action for people suffering from
schizophrenia in decades, and doctors tell us that the current
treatments often result in non-compliance due to the difficulty in
taking the medication."
Under the terms of the agreement, Retrophin will provide continued
support and guidance for this study as a named Collaborator. Financial
terms of the agreement are not being disclosed.
About the Study
The double-blind, placebo-controlled study, in collaboration with the
National Institute of Mental Health, is currently enrolling 143 patients
in three arms: 84 IU twice a day for six weeks, 42 IU twice a day for
six weeks, and placebo. The primary endpoint of the study is change in
total score from baseline to endpoint in the Positive and Negative
Syndrome Scale (PANSS). Secondary endpoints include Global Assessment of
Functioning (GAF), Clinical Global Impression-Severity of Illness
(CGI (News - Alert)-S) and Clinical Global Impression-Global Improvement (CGI-I).
Results are expected to e announced during the third quarter of 2014.
For more information, please visit http://clinicaltrials.gov/show/NCT01621737.
Retrophin is a pharmaceutical company focused on the development,
acquisition and commercialization of drugs for the treatment of serious,
catastrophic or rare diseases for which there are currently no viable
options for patients. The Company's pipeline includes compounds for
several catastrophic diseases, including Focal Segmental
Glomerulosclerosis (FSGS), Pantothenate Kinase-Associated
Neurodegeneration (PKAN), Duchenne Muscular Dystrophy and others.
Retrophin's lead compound, Sparsentan, formerly known as RE-021, is
scheduled to begin enrollment in a potentially pivotal Phase 2 clinical
trial for FSGS during 2013. The Company also intends to initiate
clinical trials for intranasal oxytocin as a potential treatment for
schizophrenia and autism. For additional information, please visit www.retrophin.com.
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regarding the research, development and commercialization of
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