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Share Name | Share Symbol | Market | Type |
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Endo International PLC | NASDAQ:ENDP | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
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0.00 | 0.00% | 0.2926 | 0.29 | 0.294 | 0 | 01:00:00 |
DUBLIN, March 14, 2017 /PRNewswire/ -- Endo International plc (NASDAQ / TSX: ENDP) today announced that the U.S. Food and Drug Administration's (FDA) Drug Safety Risk Management and Anesthetic and Analgesic Drug Products Advisory Committees voted 18 to eight, with one abstention, that the benefits of reformulated OPANA® ER (oxymorphone hydrochloride extended release) no longer outweigh its risks. While several of the Advisory Committee members acknowledged the role of OPANA® ER in clinical practice, others believed its benefits are now overshadowed by the continuing public health concerns around the product's misuse, abuse and diversion. During the Advisory Committee discussion following the vote, a number of Committee members expressed their preference that OPANA® ER remain on the market with additional regulatory restrictions to mitigate the risks.
The FDA convened these Advisory Committees to discuss pre- and post-marketing data about the abuse of OPANA® ER, the product's overall risk-benefit profile, as well as the abuse of generic oxymorphone ER and oxymorphone immediate-release (IR) products. While the FDA will consider the Committees' vote, any decision regarding whether to take regulatory action rests solely with the Agency. Endo believes that OPANA® ER remains an important clinical choice for appropriate patients and will evaluate the range of available options for maintaining access for legitimate use.
"Endo remains confident that the body of evidence established through clinical research demonstrates that OPANA® ER has a favorable risk-benefit profile when used as intended in appropriate patients," said Matthew W. Davis, M.D., R.Ph., Senior Vice President, Research & Development, Branded Pharmaceuticals at Endo. "Our top priorities include patient safety and ensuring that patients with chronic pain have access to safe and effective therapeutic options. We plan to work collaboratively with the FDA as the Agency completes its evaluation of OPANA® ER, while advocating to preserve the important benefits of the medicine for patients."
Endo's Commitment to Reducing the Abuse and Diversion of Opioid Medications
As a responsible opioid manufacturer, Endo is committed to reducing the potential abuse, misuse and diversion of these products and has taken a number of efforts to date, including:
INDICATION
OPANA® ER is an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Limitations of Use
IMPORTANT SAFETY INFORMATION ABOUT OPANA® ER
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME;
INTERACTION WITH ALCOHOL; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
Addiction, Abuse, and Misuse
OPANA® 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 OPANA® ER, and monitor all patients regularly for the development of these behaviors and conditions.
Life-threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of OPANA® ER. Monitor for respiratory depression, especially during initiation of OPANA® ER or following a dose increase. Instruct patients to swallow OPANA® ER tablets whole; crushing, chewing, or dissolving OPANA® ER tablets can cause rapid release and absorption of a potentially fatal dose of oxymorphone.
Accidental Ingestion
Accidental ingestion of even one dose of OPANA® ER, especially by children, can result in a fatal overdose of oxymorphone.
Neonatal Opioid Withdrawal Syndrome
Prolonged use of OPANA® 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.
Interaction with Alcohol
Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while taking OPANA® ER. The co-ingestion of alcohol with OPANA® ER may result in increased plasma levels and a potentially fatal overdose of oxymorphone.
Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants
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.
CONTRAINDICATIONS
OPANA® ER is contraindicated in patients with:
WARNINGS AND PRECAUTIONS
Addiction, Abuse, and Misuse
Life-threatening Respiratory Depression
Neonatal Opioid Withdrawal Syndrome
Prolonged use of OPANA® ER during pregnancy can result in withdrawal in the neonate. Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. Observe newborns for signs of neonatal opioid withdrawal symptoms and manage accordingly. Advise pregnant women using opioids for a prolonged period of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants
Life-threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, and Debilitated Patients
The use of OPANA® ER in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment is contraindicated.
Patients with Chronic Pulmonary Disease: OPANA® 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 OPANA® ER.
Elderly, Cachectic, or Debilitated Patients: 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. Monitor such patients closely, particularly when initiating and titrating OPANA® ER and when OPANA® ER is given concomitantly with other drugs that depress respiration. Alternatively, consider the use of non-opioid analgesics in these patients.
Anaphylaxis, Angioedema, and Other Hypersensitivity Reactions
Potentially life-threatening hypersensitivity reactions, including anaphylaxis and angioedema, have occurred in patients treated with OPANA® ER in the postmarket setting. The most commonly described clinical features in these reports were swelling of the face, eyes, mouth, lips, tongue, hands, and/or throat; dyspnea; hives, pruritus, and/or rash; and nausea/vomiting. If anaphylaxis or other hypersensitivity occurs, stop administration of OPANA® ER immediately, discontinue OPANA® ER permanently, and do not rechallenge with any formulation of oxymorphone. Advise patients to seek immediate medical attention if they experience any symptoms of a hypersensitivity reaction.
Adrenal Insufficiency
Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Presentation of adrenal insufficiency may include non-specific symptoms and signs, including nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. If adrenal insufficiency is suspected, confirm the diagnosis with diagnostic testing as soon as possible. If adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids. Wean the patient off of the opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers. Other opioids may be tried, as some cases reported use of a different opioid without recurrence of adrenal insufficiency. The information available does not identify any particular opioids as being more likely to be associated with adrenal insufficiency.
Use in Patients with Hepatic Impairment
A study of OPANA® ER in patients with hepatic disease indicated greater plasma concentrations than those with normal hepatic function. OPANA® ER is contraindicated in patients with moderate or severe hepatic impairment. In patients with mild hepatic impairment, reduce the starting dose to the lowest dose and monitor for signs of respiratory and central nervous system depression.
Severe Hypotension
OPANA® ER may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. There is an increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (e.g., phenothiazines or general anesthetics). Monitor these patients for signs of hypotension after initiating or titrating the dosage of OPANA® ER. In patients with circulatory shock, OPANA® ER may cause vasodilation that can further reduce cardiac output and blood pressure. Avoid the use of OPANA® ER in patients with circulatory shock.
Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired
Consciousness
Difficulty in Swallowing and Risk for Obstruction in Patients at Risk for a Small Gastrointestinal Lumen
Risks of Use in Patients with Gastrointestinal Conditions
Increased Risk of Seizures in Patients with Seizure Disorders
The oxymorphone in OPANA® ER may increase the frequency of seizures in patients with seizure disorders, and may increase the risk of seizures occurring in some other clinical settings associated with seizures. Monitor patients with a history of seizure disorders for worsened seizure control during OPANA® ER therapy.
Withdrawal
Risks of Driving and Operating Machinery
OPANA® ER may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of OPANA® ER and know how they will react to the medication.
ADVERSE REACTIONS
Clinical Trial Experience
DRUG ABUSE AND DEPENDENCE
Controlled Substance
Abuse
Risks Specific to Abuse of OPANA® ER
Dependence
Please see accompanying full Prescribing Information, including Boxed WARNING and Medication Guide.
About Endo International plc
Endo International plc (NASDAQ / TSX: ENDP) is a highly focused generics and specialty branded pharmaceutical company delivering quality medicines to patients in need through excellence in development, manufacturing and commercialization. Endo has global headquarters in Dublin, Ireland, and U.S. headquarters in Malvern, PA. Learn more at www.endo.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements" including, but not limited to, the statements by Dr. Davis. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Endo's expectations and projections. Risks and uncertainties include, among other things, general industry and market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes, including regulatory decisions; challenges related to product marketing, such as the unpredictability of market acceptance for new products and/or the acceptance of new indications for such products; inconsistency of treatment results among patients; potential difficulties in manufacturing; the outcome of litigation, settlement discussions or other adverse proceedings; general economic conditions; and governmental laws and regulations affecting domestic and foreign operations. Endo expressly disclaims any intent or obligation to update these forward-looking statements except as required by law. Additional information concerning these and other risk factors can be found in Endo's periodic reports filed with the U.S. Securities and Exchange Commission and in Canada on the System for Electronic Data Analysis and Retrieval ("SEDAR"), including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K. Additional information about Endo is available on the World Wide Web at www.endo.com or you can contact the Endo Investor Relations department by calling (484) 216-0000.
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/endo-statement-on-fda-advisory-committees-vote-related-to-opana-er-300423788.html
SOURCE Endo International plc
Copyright 2017 PR Newswire
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