LONDON, UK / ACCESSWIRE / September 26, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Allergan PLC (NYSE: AGN), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=AGN. The Company announced on September 22, 2017, that it received a Refusal to File (RTF) letter from the US Food and Drug Administration (FDA) for its Supplemental New Drug Application (sNDA) for Vraylar (cariprazine). For immediate access to our complimentary reports, including today's coverage, register for free now at:

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On the basis of a preliminary review, FDA announced that the sNDA for treatment of negative symptoms was not yet adequately complete to allow a substantive review.

What is Schizophrenia?

Schizophrenia is a chronic and disabling disorder. It comprises some positive symptoms such as hallucinations, delusions, and thought disorders as well as some negative symptoms such as loss of motivation and social withdrawal. In fact, a majority of these symptoms lead to long-term morbidity, poor psychosocial functioning and considerable social and economic costs.

About Vraylar

Vraylar is an oral, once daily atypical antipsychotic for the treatment of schizophrenia and the acute treatment of adult patients with manic or mixed episodes associated with bipolar I disorder. It has already been approved in the United States. Its recommended dosage for bipolar-I disorder ranges from 3 to 6 mg/day, and for the treatment of schizophrenia in adults, from 1.5 to 6 mg/day.

Gedeon Richter PLC discovered and co-developed Vraylar while it was licensed to Allergan in the US and Canada. Currently, Vraylar is approved in Europe for the treatment of schizophrenia. The approval is based on the 460-patient negative symptoms study, which was conducted by Gedeon Richter and published in the Lancet on February 06, 2017.

How Vraylar works?

As of now, the action mechanism of Vraylar in schizophrenia and bipolar-I disorder is unspecified. However, its efficacy can be mediated through a combination of partial agonist activity at central dopamine D? and serotonin 5-HT1A receptors and antagonist activity at serotonin 5-HT2A receptors.

Pharmacodynamics studies with cariprazine have demonstrated that it acts as a partial agonist at dopamine D3, dopamine D2, and with a high binding affinity at the serotonin 5-HT1A. Cariprazine showed up to ~8-fold greater in vitro affinity for dopamine D3 compared to D2 receptors.

Cariprazine is also an antagonist at serotonin 5-HT2B and 5-HT2A receptors with high and moderate binding affinity, respectively, as well as it binds to the histamine H1 receptors. However, it has a lower binding affinity to the serotonin 5-HT2C and ?1A - adrenergic receptors and has no considerable affinity for cholinergic muscarinic receptors. The clinical significance of these in vitro data is unidentified.

Allergan Disappointed with this Decision

David Nicholson, Ph.D., Chief Research and Development Officer at Allergan, highlighted that the Company is dissatisfied with the FDA's decision on the submission. He mentioned that they would appeal for a meeting with the FDA to discuss as well as decide the future course of action.

Vraylar has become an essential treatment option for patients suffering from bipolar-I disorder and schizophrenia. The Company would continue to focus on its mental health program and would remain committed to VRAYLAR and its potential as a treatment option for patients suffering from negative symptoms associated with schizophrenia.

A follow-up Meeting with FDA

Allergan intends to seek immediate guidance for the Refusal to File (RTF) letter. In fact, the Company is planning a meeting with the FDA, to respond to issues, as well as to seek clarification of what additional information would be required for the approval.

About Allergan PLC

Allergan is a global pharmaceutical company which has become the leader in the new industry model i.e. Growth Pharma. Allergan is headquartered in Dublin, Ireland, with commercial operations in nearly 100 countries. The Company works towards developing, manufacturing, and commercializing branded pharmaceutical, device, and biologic, surgical, and regenerative medicine products for patients around the world. Allergan dedicatedly works with physicians, healthcare providers, and patients to deliver innovative treatments to help people live longer and healthier lives.

Last Close Stock Review

At the close of trading session on Monday, September 25, 2017, Allergan's stock price rose 3.40% to end the day at $211.61. A total volume of 3.98 million shares were exchanged during the session, which was above the 3-month average volume of 2.17 million shares. The Company's shares have a dividend yield of 1.32%. At Monday's closing price, the stock's net capitalization stands at $70.93 billion.

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