DUBLIN, June 8, 2017 /PRNewswire/ -- Endo International plc (NASDAQ: ENDP) is aware of today's announcement by the U.S. Foodand Drug Administration (FDA) requesting that Endo voluntarily withdraw OPANA® ER (oxymorphone hydrochloride extended release) from the market. Endo is reviewing the request and is evaluating the full range of potential options as we determine
While the benefits of opioids in treating and managing pain are widely recognized, the misuse and abuse of these products have increased greatly in the U.S. As a pharmaceutical company with a demonstrated commitment to the improvement of pain management, Endo feels a strong sense of responsibility to improve the care of pain for patients while at the same time taking comprehensive steps to minimize the potential misuse of its products.
Despite the FDA's request to withdraw OPANA® ER from the market, this request does not indicate uncertainty with the product's safety or efficacy when taken as prescribed. Endo remains confident in the body of evidence established through clinical research demonstrating that OPANA® ER has a favorable risk-benefit profile when used as intended in appropriate patients.
FDA Drug Safety Risk Management and Anesthetic and Analgesic Drug Products Advisory Committees Meeting Outcome
On March 13 and 14, 2017, the U.S. Food and Drug Administration's (FDA) Drug Safety Risk Management and Anesthetic and Analgesic Drug Products Advisory Committees were convened 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 Advisory Committee members voted 18 to eight, with one abstention, that the benefits of reformulated OPANA® ER no longer outweigh its risks, more than half expressed their preference that OPANA® ER remain on the market, but with additional regulatory restrictions to mitigate the risks of misuse and abuse.
INDICATIONOPANA® 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 MisuseOPANA® 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 DepressionSerious, 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 IngestionAccidental ingestion of even one dose of OPANA® ER, especially by children, can result in a fatal overdose of oxymorphone.
Neonatal Opioid Withdrawal SyndromeProlonged 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 AlcoholInstruct 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 DepressantsConcomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.
CONTRAINDICATIONSOPANA® ER is contraindicated in patients with:
WARNINGS AND PRECAUTIONS Addiction, Abuse, and Misuse
Life-threatening Respiratory Depression
Neonatal Opioid Withdrawal SyndromeProlonged 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 PatientsThe 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 ReactionsPotentially 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 InsufficiencyCases 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 ImpairmentA 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 HypotensionOPANA® 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 ImpairedConsciousness
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 DisordersThe 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.
Risks of Driving and Operating MachineryOPANA® 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
Risks Specific to Abuse of OPANA® ER
Please see accompanying full Prescribing Information, including Boxed WARNING and Medication Guide.
About Endo International plcEndo International plc (NASDAQ: 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 StatementsThis press release contains "forward-looking statements," including, but not limited to, statements regarding the FDA's request to withdraw OPANA® ER, the Company's evaluation of potential options and the potential impact of such request and evaluation on the Company's business and expected, estimated or anticipated future results. Because forecasts are inherently estimates that cannot be made with precision, the Company's performance may differ materially from its expectations, estimates and targets, and the Company often does not know what the actual results will be until after the end of the applicable reporting period. Therefore, the Company will not report or comment on its progress during a current quarter except through public announcement. Any statement made by others with respect to progress during a current quarter cannot be attributed to the Company. All forward-looking statements in this press release reflect the Company's current analysis of information and represent the Company's judgment only as of the date of this press release. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the Company's expectations. 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, product recalls, withdrawals and other unusual items; 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. The Company 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 the Company'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.
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SOURCE Endo International plc
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