טבע תציג נתונים חדשים אודות AUSTEDO® (deutetrabenazine) בקונגרס הפסיכיאטרי 2019

טבע

טבע תעשיות פרמצבטיות בע"מ (NYSE ו- TASE: TEVA) הודיעה היום כי נתונים אודות AUSTEDO® (deutetrabenazine) יוצגו בקונגרס הפסיכיאטרי השנתי ה-32 בין 3-6 לאוקטובר, 2019 בסן דייגו קליפורניה. המצגות יכללו ניתוח נוסף של מרכיבי AIMS (פריטים 8-10) מתוך המחקרים הפיבוטליים ARM-TD ו- AIM-TD אשר בחנו את טבליות AUSTEDOלטיפול בדיסקינזיה מאוחרת בבגירים; ניתוח של השפעת AUSTEDO על פרמטרים מטבוליים בטיפול בדיסקינזיה מאוחרת במחקרים הפיבוטליים וכן במחקר ארוך הטווח; וניתוח של עיצוב מחקר הנסיגה אשר בחן את הישנות ההשפעה הטיפולית של AUSTEDO בדיסקינזיה מאוחרת. נתונים נוספים כוללים שתי מצגות המראות את תוצאות המחקר הראשון אשר מכמת את הסטיגמה אשר אנשים עם דיסקינזיה מאוחרת מתמודדים איתה במצבים מקצועיים וחברתיים.

"נתונים חדשים אלו תורמים להבנה שלנו אודות פרופיל הסיכון-תועלת של AUSTEDO בדיסקינזיה מאוחרת", אמר ד"ר דני מקבריאן, סמנכ"ל בכיר, המנהל הרפואי הראשי בטבע. "בנוסף, אנו מצפים לחלוק תובנות מהמחקרים שלנו אשר מכמת את הסטיגמה המקצועית והחברתית הכרוכה במחלה זו".

להלן מבחר תקצירים שנתקבלו להצגה במהלך השנה:

All posters will be presented at the Poster Pavilion on both Friday, October 4 and Saturday, October 5 from 1:30-3:00 p.m. PDT.

Poster 105: Analysis of AIMS Global Judgment Components (Items 8-10) in Patients With TD: Results From the ARM-TD and AIM-TD Studies
Poster 115: An Experimental Study to Assess the Professional and Social Consequences of Mild-to-Moderate Tardive Dyskinesia
Poster 116: An Experimental Study to Assess the Professional and Social Consequences of Tardive Dyskinesia
Poster 117: Impact of Antipsychotic Treatment Switching in Patients With Schizophrenia, Bipolar Disorder, and Major Depressive Disorder
Poster 148: Long-Term Treatment With Deutetrabenazine Is Associated With Continued Improvement in Tardive Dyskinesia (TD): Results From an Open-Label Extension Study
Poster 158: Effect of Deutetrabenazine on Metabolic Parameters in the Treatment of Tardive Dyskinesia
Poster 315: Randomized Withdrawal Study Design to Evaluate the Persistence of the Therapeutic Effect of Deutetrabenazine in the Treatment of Tardive Dyskinesia

About AUSTEDO® (deutetrabenazine)

AUSTEDO® is a vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the U.S. Food and Drug Administration for the treatment of tardive dyskinesia in adults and for the treatment of chorea associated with Huntington’s disease. Safety and effectiveness in pediatric patients have not been established.

The use of deutetrabenazine for the treatment of Tourette syndrome is investigational and not currently approved by the U.S. Food and Drug Administration or any other country’s regulatory agency for this use.

Indications and Usage
AUSTEDO® is indicated for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia in adults.

Important Safety Information
Depression and Suicidality in Patients with Huntington’s Disease: AUSTEDO® can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Balance the risks of depression and suicidality with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior. Inform patients, their caregivers, and families of the risk of depression and suicidality and instruct them to report behaviors of concern promptly to the treating physician. Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation. AUSTEDO® is contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression.

Contraindications: AUSTEDO® is contraindicated in patients with Huntington’s disease who are suicidal, or have untreated or inadequately treated depression. AUSTEDO® is also contraindicated in: patients with hepatic impairment; patients taking reserpine or within 20 days of discontinuing reserpine; patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing MAOI therapy; and patients taking tetrabenazine (Xenazine®) or valbenazine (Ingrezza®).

Clinical Worsening and Adverse Events in Patients with Huntington’s Disease: AUSTEDO® may cause a worsening in mood, cognition, rigidity, and functional capacity. Prescribers should periodically re-evaluate the need for AUSTEDO® in their patients by assessing the effect on chorea and possible adverse effects.

QTc Prolongation: Tetrabenazine, a closely related VMAT2 inhibitor, causes an increase in the corrected QT (QTc) interval. A clinically relevant QT prolongation may occur in some patients treated with AUSTEDO® who are CYP2D6 poor metabolizers or are co-administered a strong CYP2D6 inhibitor. Dose reduction may be necessary. The use of AUSTEDO® in combination with other drugs known to prolong QTc may result in clinically significant QT prolongations. For patients requiring AUSTEDO® doses greater than 24 mg per day who are using AUSTEDO® with other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of AUSTEDO® or the other drugs. AUSTEDO® should be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias.

Neuroleptic Malignant Syndrome (NMS), a potentially fatal symptom complex reported in association with drugs that reduce dopaminergic transmission, has been observed in patients receiving tetrabenazine. The risk may be increased by concomitant use of dopamine antagonists or antipsychotics. The management of NMS should include immediate discontinuation of AUSTEDO®; intensive symptomatic treatment and medical monitoring; and treatment of any concomitant serious medical problems.

Akathisia, Agitation, and Restlessness: AUSTEDO® may increase the risk of akathisia, agitation, and restlessness. The risk of akathisia may be increased by concomitant use of dopamine antagonists or antipsychotics. If a patient develops akathisia, the AUSTEDO® dose should be reduced; some patients may require discontinuation of therapy.

Parkinsonism: AUSTEDO® may cause parkinsonism in patients with Huntington’s disease or tardive dyskinesia. Parkinsonism has also been observed with other VMAT2 inhibitors. The risk of parkinsonism may be increased by concomitant use of dopamine antagonists or antipsychotics. If a patient develops parkinsonism, the AUSTEDO® dose should be reduced; some patients may require discontinuation of therapy.

Sedation and Somnolence: Sedation is a common dose-limiting adverse reaction of AUSTEDO®. Patients should not perform activities requiring mental alertness, such as operating a motor vehicle or hazardous machinery, until they are on a maintenance dose of AUSTEDO® and know how the drug affects them. Concomitant use of alcohol or other sedating drugs may have additive effects and worsen sedation and somnolence.

Hyperprolactinemia: Tetrabenazine elevates serum prolactin concentrations in humans. If there is a clinical suspicion of symptomatic hyperprolactinemia, appropriate laboratory testing should be done and consideration should be given to discontinuation of AUSTEDO®.

Binding to Melanin-Containing Tissues: Deutetrabenazine or its metabolites bind to melanin-containing tissues and could accumulate in these tissues over time. Prescribers should be aware of the possibility of long-term ophthalmologic effects.
CYP2D6 Metabolism: In patients who are poor CYP2D6 metabolizers or are taking strong CYP2D6 inhibitors, the total daily dosage of AUSTEDO® should not exceed 36 mg (maximum single dose of 18 mg).

Common Adverse Reactions: The most common adverse reactions for AUSTEDO® (>8% and greater than placebo) in a controlled clinical study in patients with Huntington’s disease were somnolence, diarrhea, dry mouth, and fatigue. The most common adverse reactions for AUSTEDO® (4% and greater than placebo) in controlled clinical studies in patients with tardive dyskinesia were nasopharyngitis and insomnia.

Please see accompanying full Prescribing Information, including Boxed Warning.

אודות טבע
טבע תעשיות פרמצבטיות בע"מ (NYSE & TASE: TEVA) מפתחת ומייצרת תרופות לשיפור חייהם של אנשים מזה למעלה ממאה שנה. אנו מובילים גלובליים בגנריקה ובתרופות ייחודיות, עם פורטפוליו הכולל יותר מ- 2,400 מוצרים בכמעט כל תחום טיפולי. בכל יום, קרוב ל-200 מיליון אנשים ברחבי העולם נוטלים תרופה של טבע, הודות לאחת ממערכות התפעול הגדולות והמורכבות בתעשייה הפרמצבטית. נוסף על מעמדנו המבוסס בגנריקה, יש לנו פעילות מחקר חדשני משמעותית התומכת בפורטפוליו המוצרים הייחודיים והביופרמצבטיים הגדל שלנו. למידע נוסף על החברה, בקרו באתר www.Teva.co.il