On March 27, we wrote about how positive results of Neurocrine Biosciences (NBIX) drug Ingrezza on Tardive Dyskinesia (TD) will highlight Neurocrine Biosciences and its Scientists. We wrote: The results published online by The American Journal of Psychiatry demonstrate that Phase 3 trial with Ingrezza conducted on patients with tardive dyskinesia showed significant and meaningful reduction in symptoms. We elaborated on the trial that provided the results on 234 subjects with tardive dyskinesia (TD) and mood disorder (including bipolar disorder or major depressive disorder) and how the patients were treated with Neurocrine drug.
Our conclusion that the trial results would be the game changer for Neurocrime came in the title of the article “Neurocrine Biosciences (NBIX): Time for Transformation and More Achievements.”
It did not take long for the good news about the drug and the firm materializes. On April 11, 2017, Neurocrine announced that the FDA has approved Ingrezza™ (valbenazine) capsules for adults with tardive dyskinesia (TD).
Ingrezza™. Neurocrine’s novel, selective vesicular monoamine transporter 2 (VMAT2) inhibitor, became the first and only FDA-approved product indicated for the treatment of adults with TD. Commenting on the apprpoval Kevin C. Gorman, Chief Executive Officer of Neurocrine Biosciences stated, “The often debilitating effects of tardive dyskinesia have left people feeling isolated and forgotten. The approval of Ingrezza represents a turning point for these patients and their care partners, offering a meaningful treatment where before there was little hope.”
Explaining the importance of the approved drug, Christoph U. Correll, MD, Professor, Psychiatry and Molecular Medicine, Hofstra Northwell School of Medicine said, “Until now, one of the few options for physicians, when managing TD, was to either stop, change or lower the dose of antipsychotic medication, potentially jeopardizing patients’ psychiatric stability, in clinical trials, Ingrezza significantly and rapidly improved TD symptoms compared to placebo, reducing involuntary movements acutely and through 48 weeks of treatment without compromising underlying psychiatric care. These results, combined with convenient once-daily dosing, represent a tremendous breakthrough for patients suffering from TD.”
Indeed, the clinical trial results demonstrate that Ingrezza provides significant, rapid and meaningful improvement in TD signs and symptoms compared to placebo through six weeks, with continued reductions in TD observed through 48 weeks of treatment. The drug was generally well tolerated, with somnolence as the only adverse event occurring at a rate greater than or equal to 5 percent and twice placebo. NO worsening in safety scale scores for depression, suicidal ideation or behaviors was observed. Ingrezza has been studied in over 1,000 individuals and more than 20 clinical trials.
Paul Gionfriddo, President & CEO of Mental Health America said, “A treatment for tardive dyskinesia is a welcome and exciting step in the continued effort to destigmatize mental health conditions. With an FDA approved treatment now available, individuals and doctors can have more productive and proactive conversations about TD.”
Good news for patients with tardive dyskinesia is that the drug distribution will begin next week.
To assist tardive dyskinesia patients in gaining access to Ingrezza, Neurocrine has created the INBRACE™ patient support program, which will immediately begin accepting treatment initiation forms from health care professionals prescribing the novel drug and work closely with patients and their families to facilitate access.
The recently approved Ingrezza is the kind of drug that we love to see biotech firms and drug developing firms of all kinds create. Such drugs are game changers of lives of patients who suffer from debilitating diseases with no hope for a treatment that would take away their suffering. The approvals of such drugs come as unexpected, but hoped for, miracles that would suddenly delete the pain and desperation of the suffering patients and replace them with hope and wellbeing.
Tardive dyskinesia (TD) is a potentially chronic condition that can hit people following the use of dopamine receptor blocking agents, including antipsychotics and metoclopramide. The signs include involuntary movements of the face, mouth, trunk, and extremities. These movements (or TD) may impact patients’ lives and those who care for them.
It is estimated that at least 500,000 people in the US are affected by Tardive Dyskinesia.
Neurocrine Biosciences is a San Diego based biotechnology company focused on neurologic, psychiatric and endocrine related disorders.
1. CENTRAL NERVOUS SYSTEM
Ingrezza: In Phase 2 trial for Tourette Syndrome
NBI-640756: In Phase 1 for essential tremor
Opicapone: In Phase 3 for Parkinson’s Disease. The drug is a Catechol-O-methyltransferase inhibitor (BIAL)
Ingrezza™ (valbenazine), a novel, once-daily, selective VMAT2 inhibitor that has just been approved for the treatment of adults with tardive dyskinesia and will be commercialized by Neurocrine in the United States.
Opicapone is a novel, once-daily, peripherally-acting, highly-selective catechol-o-methyl-transferase inhibitor under investigation as adjunct therapy to levodopa in Parkinson’s patients.
Elagolix, a gonadotropin-releasing hormone antagonist for women’s health that is partnered with AbbVie for the treatment of endometriosis and uterine fibroids.
Two early drugs both in preclinical trials: One for congenital adrenal hyperplasia and the second is a GnRH Antagonist.
Neurocrine’s research group utilizes advanced technologies to enable its scientists enhance drug discovery capabilities and accelerate the drug development process. The firm’s chemists, pharmacologists and biologists work together to create new solutions for unmet medical needs, one of them is Ingrezza™, which was granted FDA approval
Neurocrine Symbol: NBIX
Current Stock Price: $51
Market Cap: $4.5 Billion
52-week average: $37.35 — $55.15
PROHOST 2017 Target: Subscribers, see the upcoming Prohost Letter #407, which will be posted on Sunday April 16, 2017.
As we mentioned in the beginning of the article. We consider the FDA approval of Ingrezza a game changer for Neurocrine life and value. We highly regard this firm and its science and scientists and believe they will experience more successful outcomes of its pipeline products.
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