Positive Study Results for Aripiprazole Will Lead to NDA


Aripiprazole-129722-12-9Alkermes excitedly announced extremely positive study data from a Phase 3 trial of Aripiprazole. This randomized, placebo-controlled and double-blind study gleaned better than expected results, leading pharmaceutical executives at Alkermes to set a plan in motion for an NDA by the third quarter of 2014. As a long acting and injectable antipsychotic treatment Aripiprazole Lauroxil is now available as a once a month dosage in either 441 milligrams or 882 milligrams.

Geared for patients with Schizophrenia, Bipolar Disorder and Major Depressive Disorder Aripiprazole is also known as the brand name Abilify, which is marketed by Bristol-Myers Squibb and Otsuka. Once injected the novel antipsychotic Aripiprazole Lauroxil converts to the molecule Aripiprazole, safely alleviating symptoms of mental illness for roughly one month. The Aripiprazole injectable dose has also proven to be efficacious for sufferers of Bipolar Disorder, as it works to help patients control the highs and lows of manic episodes. Complete Phase 3 study data revealed that not only were primary efficacy endpoints met for the patients who were administered the once a month injection of Aripiprazole, but also this unique form of delivery proved to be as effectual and tolerable as the oral dosage. Side effects from the injectable Aripiprazole were similar to those of the oral form of this drug, and included complaints of mainly headache and fatigue.

Schizophrenia is a severe form of mental illness which affects roughly seven of every thousand adults worldwide, with the vast majority of patients being between the ages of 15 and 35 years of age. One percent of Americans are diagnosed with Schizophrenia and both males and females are affected equally. Schizophrenia occurs across racial boundaries and is currently becoming more commonly diagnosed in children. With WHO estimating 24 million people to have a diagnosis of Schizophrenia worldwide the need for research and development of safe and effective drugs is urgent. The World Health Organization clearly states that Schizophrenia is a treatable condition, but has recently voiced concerns that over half of all patients diagnosed with this serious mental illness do not receive appropriate pharmaceutical care.

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