Retrophin announced it has signed an agreement with Novartis for an exclusive license for Syntocinon (oxytocin) Nasal Spray. Syntocinon Nasal Spray was initially approved in 1960 to assist initial postpartum milk ejection, but was discontinued in 1997 by Novartis for commercial reasons.

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Oxytocin is a naturally occurring peptide hormone that stimulates contraction of uterine smooth muscle, thus mimicking contractions of normal, spontaneous labor and transiently impeding uterine blood flow. Oxytocin also stimulates smooth muscle to facilitate ejection of milk from breasts.

Syntocinon nasal spray will also be evaluated in a clinical trial program for its potential use as treatment for schizophrenia and autism

Previously, three randomized, double-blind, placebo-controlled, independent proof-of-concept schizophrenia trials were conducted in patients whose symptoms were inadequately controlled despite receiving therapeutic doses of an atypical antipsychotic. 

All studies suggested that intranasal oxytocin administered as adjunct to antipsychotic drugs improves positive and negative symptoms, as assessed by the Positive and Negative Syndrome Scale (PANSS), significantly more than placebo.

Retrophin plans to reintroduce Syntocinon Nasal Spray in the second quarter of 2014.

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