טבע קיבלה את אישור ה- FDA עבור טבליות VANTRELA ER

ההתוויה של VANTRELA ER מתארת את תכונות המוצר המרתיעות שימוש לרעה בטבליות בשלוש הדרכים הנפוצות ביותר - בלקיחה דרך הפה, דרך האף ודרך הווריד

ירושלים, 18 בינואר, 2017 – טבע תעשיות פרמצבטיות בע"מ (NYSE ו-TASE: TEVA) הודיעה היום כי מנהל המזון והתרופות האמריקאי (FDA) אישר את טבליות VANTRELATM ER (hydrocodone bitartrate) בשחרור מושהה [CII], שפותחו עם טכנולוגיה ייחודית של טבע להרתעת שימוש לרעה בתרופות.

VANTRELA ER מותווה לטיפול בכאב חריף וקבוע, המצריך טיפול יומיומי מסביב לשעון באופיואידים, וללא אפשרויות טיפול חלופיות הולמות. אישור המוצר נתמך בממצאים של תכנית המחקרים הקליניים שנועדה להעריך את הבטיחות והיעילות של VANTRELA ER, וכן להעריך את פוטנציאל השימוש לרעה במוצר באמצעות ניסויי מעבדה שכללו מניפולציות ופירוק במבחנות, מחקרים פרמקוקינטיים, ומחקרים קליניים על פוטנציאל השימוש לרעה (CAP).

"טבע מבינה היטב את הסיכון הכרוך בשימוש לרעה בתרופות מרשם ואת הקושי שהוא מציב בפני רופאים המטפלים במיליוני אמריקאים הסובלים מכאבים כרוניים," אמר ד"ר רוב קורמנס, נשיא ומנכ"ל קבוצת התרופות הייחודיות הגלובלית של טבע. "טיפולים המרתיעים שימוש לרעה מספקים אופציות לרופאים אשר עשויות להרתיע או להפחית שימוש לרעה תוך שימור הגישה לתרופות כאב עבור המטופלים הזקוקים להן."

ההתוויה של VANTRELA ER מתארת את תכונות המוצר המרתיעות שימוש לרעה, הצפויות להפחית, אם כי לא למנוע לחלוטין, שימוש לרעה על ידי לקיחת התרופה דרך הפה, דרך האף או דרך הווריד כאשר הטבליות עוברות מניפולציה כלשהי. כתרופה אופיואידית השימוש ב- VANTRELA ER כרוך בסיכונים חמורים ועל גבי אריזת התרופה מופיעה אזהרה מפני התמכרות, שימוש לרעה ושימוש בצורה לא נכונה, שעלולים להביא לצריכה של מנת יתר ולמוות, וכן לגרום לדיכוי חמור של מערכת הנשימה שעלול להיות מסוכן ואף קטלני. מידע נוסף בנושא בטיחות מופיע למטה ובעלון המידע הנלווה לתרופה.

ד"ר מייקל היידן, נשיא המו"פ הגלובלי והמדען הראשי של טבע אמר, "בעוד שאין טכנולוגיה שיכולה למנוע לחלוטין שימוש לרעה, הטכנולוגיה הקניינית שפיתחה טבע להרתעת שימוש לרעה היא צעד חשוב בכיוון הנכון. אנו מחויבים לקידום תחום הניהול האחראי של כאבים."

תופעות לוואי בקרב 2% או יותר מהמטופלים בניסויים מבוקרי-פלצבו כללו בחילות, עצירות, כאב ראש, ישנוניות, הקאות, סחרחורות, תחושת עקצוץ, עייפות, יובש בפה, שלשולים, נדודי שינה וחרדה.

Limitation of Use

  • Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve VANTRELA ER for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
  • VANTRELA ER is not indicated as an as-needed (prn) analgesic.

VANTRELA ER contains hydrocodone, a substance with a high potential for abuse similar to other opioids, including fentanyl, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and tapentadol.

Important Safety Information

VANTRELA ER exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing VANTRELA ER and monitor all patients regularly for the development of these behaviors and conditions. Serious, life-threatening, or fatal respiratory depression may occur with the use of VANTRELA ER. Monitor for respiratory depression, especially during initiation of VANTRELA ER or following a dose increase. Instruct patients to swallow VANTRELA ER tablets whole; crushing, chewing or dissolving VANTRELA ER tablets can cause rapid release and absorption of a potentially fatal dose of hydrocodone. Accidental ingestion of even one dose of VANTRELA ER, especially by children, can result in a fatal overdose of hydrocodone. Prolonged use of VANTRELA ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

The concomitant use of VANTRELA ER with all cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in hydrocodone plasma concentration. Monitor patients receiving VANTRELA ER and any CYP3A4 inhibitor or inducer. Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.

  • Reserve concomitant prescribing of VANTRELA ER and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
  • Limit dosages and durations to the minimum required.
  • Follow patients for signs and symptoms of respiratory depression and sedation.

VANTRELA ER is contraindicated in patients with: significant respiratory depression; acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment; known or suspected gastrointestinal obstruction, including paralytic ileus; or hypersensitivity (e.g., anaphylaxis) to hydrocodone bitartrate or any other ingredients in VANTRELA ER.

VANTRELA ER-treated patients with significant chronic obstructive pulmonary disease or cor pulmonale, and those with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression are at increased risk of decreased respiratory drive including apnea, even at recommended dosages of VANTRELA ER.

Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients because they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients.

Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.

VANTRELA ER may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. There is an added risk to individuals whose ability to maintain blood pressure has been compromised by a depleted blood volume or concurrent administration of certain CNS depressants (e.g., phenothiazines or general anesthetics). In patients with circulatory shock, VANTRELA ER may cause vasodilation that can further reduce cardiac output and blood pressure.

In patients who may be susceptible to the intracranial effects of CO2 retention (e.g., those with evidence of increased intracranial pressure as can be caused by certain brain tumors), VANTRELA ER may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure. Opioids may also obscure the clinical course in a patient with a head injury.

The hydrocodone in VANTRELA ER may cause spasm of the sphincter of Oddi. Opioids may cause increases in serum amylase.

The hydrocodone in VANTRELA ER may increase the frequency of seizures in patients with seizure disorders, and may increase the risk of seizures occurring in other clinical settings associated with seizures.

Avoid the use of mixed agonist/antagonist (e.g., pentazocine, nalbuphine, and butorphanol) or partial agonist (e.g., buprenorphine) analgesics in patients who are receiving a course of therapy with a full opioid agonist analgesic, including VANTRELA ER. In these patients, mixed agonist/antagonist and partial agonist analgesics may reduce the analgesic effect and/or may precipitate withdrawal symptoms.

VANTRELA ER may impair the mental and physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. QTc prolongation has been observed with VANTRELA ER. Adverse reactions reported in ≥2% of patients in the placebo-controlled trials include: nausea, constipation, headache, somnolence, vomiting, dizziness, pruritus, fatigue, dry mouth, diarrhea, insomnia, and anxiety. The Full Prescribing Information, including the Boxed Warning and Medication Guide for VANTRELA ER is available at VANTRELAER.com.

A copy of the Prescribing Information may also be requested from the US Medical Information Contact Center for Teva Specialty Medicines at 888-4-TEVA-RX (888-483-8279) and USMedInfo@tevapharm.com or Teva’s Public Relations or Investor Relations contacts.

אודות טבע

טבע תעשיות פרמצבטיות בע"מ (NYSE & TASE: TEVA) היא חברת תרופות גלובלית המספקת פתרונות בריאות ממוקדי-מטופל באיכות גבוהה למיליוני מטופלים מדי יום. טבע, שבסיסה בישראל, היא יצרנית התרופות הגנריות הגדולה בעולם, הממנפת את צבר מוצריה הכולל יותר מ-1000 מולקולות לייצר מגוון רחב של מוצרים גנריים בכמעט כל התחומים הטיפוליים. בתחום התרופות הייחודיות, טבע הינה חברה מובילה בטיפולים חדשניים למחלות מערכת העצבים המרכזית, כולל כאב, ומחזיקה גם בצבר מוצרים חזק בתחום מחלות הנשימה. טבע משלבת את כישוריה בתחום התרופות הגנריות ובתחום התרופות הייחודיות בחטיבת המחקר והפיתוח הגלובלית שלה, במטרה ליצור דרכים חדשות לענות על צרכי המטופלים וזאת על ידי שילוב יכולות בתחום פיתוח תרופות יחד עם פיתוח תכשירים, שירותים וטכנולוגיות. הכנסות טבע בשנת 2014 הסתכמו ב-20.3$ מיליארד. למידע נוסף על החברה, בקרו באתר www.tevapharm.com. 

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to:

  • uncertainties relating to the potential benefits and success of our new structure and recent senior management changes as well as the potential success and our ability to effectively execute a restructuring plan;
  • our generics medicines business, including: that we are substantially more dependent on this business, with its significant attendant risks, following our acquisition of Allergan plc’s worldwide generic pharmaceuticals business (“Actavis Generics”); our ability to realize the anticipated benefits of the acquisition (and any delay in realizing those benefits) or difficulties in integrating Actavis Generics; the increase in the number of competitors targeting generic opportunities and seeking U.S. market exclusivity for generic versions of significant products; price erosion relating to our generic products, both from competing products and as a result of increased governmental pricing pressures; and our ability to take advantage of high-value biosimilar opportunities;
  • our specialty medicines business, including: competition for our specialty products, especially Copaxone®, our leading medicine, which faces competition from existing and potential additional generic versions and orally-administered alternatives; our ability to achieve expected results from investments in our product pipeline; competition from companies with greater resources and capabilities; and the effectiveness of our patents and other measures to protect our intellectual property rights;
  • our substantially increased indebtedness and significantly decreased cash on hand, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments, and may result in a downgrade of our credit ratings;
  • our business and operations in general, including: our ability to develop and commercialize additional pharmaceutical products; manufacturing or quality control problems, which may damage our reputation for quality production and require costly remediation; interruptions in our supply chain; disruptions of our or third party information technology systems or breaches of our data security; the failure to recruit or retain key personnel;the restructuring of our manufacturing network, including potential related labor unrest; the impact of continuing consolidation of our distributors and customers; variations in patent laws that may adversely affect our ability to manufacture our products; our ability to consummate dispositions on terms acceptable to us; adverse effects of political or economic instability, major hostilities or terrorism on our significant worldwide operations; and our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions;
  • compliance, regulatory and litigation matters, including: costs and delays resulting from the extensive governmental regulation to which we are subject; the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage; potential additional adverse consequences following our resolution with the U.S. government of our FCPA investigation; governmental investigations into sales and marketing practices; potential liability for sales of generic products prior to a final resolution of outstanding patent litigation; product liability claims; increased government scrutiny of our patent settlement agreements; failure to comply with complex Medicare and Medicaid reporting and payment obligations; and environmental risks;
  • other financial and economic risks, including: our exposure to currency fluctuations and restrictions as well as credit risks; the significant increase in our intangible assets, which may result in additional substantial impairment charges; potentially significant increases in tax liabilities; and the effect on our overall effective tax rate of the termination or expiration of governmental programs or tax benefits, or of a change in our business;


and other factors discussed in our Annual Report on Form 20-F for the year ended December 31, 2016 (“Annual Report”), including in the section captioned “Risk Factors,” and in our other filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov and www.tevapharm.com. Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements. 

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