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Endo Provides Update On OPANA® ER

DUBLIN , July 6, 2017 /CNW/ -- Endo International plc (ENDP) continues to believe in the safety, efficacy, and favorable benefit-risk profile of OPANA® ER (oxymorphone hydrochloride extended release) when used as intended, and notes that the Company has taken significant steps over the years to combat misuse and abuse. Nevertheless, after careful consideration and consultation with the FDA following the FDA's June 2017 withdrawal request, the Company has decided to voluntarily remove OPANA® ER from the market. As a result, the Company expects to incur a pre-tax impairment charge of approximately $20 million in the second quarter of 2017 to write-off the remaining net book value of its OPANA® ER intangible asset. Reported net sales of OPANA® ER were $158.9 million for full-year 2016 and $35.7 million for first quarter 2017.

Endo plans to work with FDA to coordinate the orderly removal of OPANA® ER in a manner that looks to minimize treatment disruption for patients and allows patients sufficient time to seek guidance from their healthcare professionals. Patients taking OPANA® ER should discuss treatment options with their prescribing physician at their next visit.

Endo reiterates that neither the FDA's withdrawal request nor Endo's decision to voluntarily remove OPANA® ER from the market reflect a finding that the product is not safe or effective when taken as prescribed. To the contrary, Endo remains confident in the clinical research and other data demonstrating OPANA® ER's safety and efficacy, as well as its favorable risk-benefit profile when used as intended in appropriate patients.

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

  • 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 OPANA® 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.
  • OPANA® ER is not indicated as an as-needed (prn) analgesic.

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.
Reserve concomitant prescribing of OPANA® 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.

  • Significant respiratory depression
  • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
  • Hypersensitivity to oxymorphone (e.g., anaphylaxis)
  • Moderate and severe hepatic impairment
  • Known or suspected gastrointestinal obstruction, including paralytic ileus

WARNINGS AND PRECAUTIONS
Addiction, Abuse, and Misuse

  • OPANA® ER contains oxymorphone, a Schedule II controlled substance. Because extended-release products such as OPANA® ER deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of oxymorphone present.
  • Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed OPANA® ER. Addiction can occur at recommended doses and if the drug is misused or abused.
  • Assess each patient's risk for opioid addiction, abuse, or misuse prior to prescribing OPANA® ER, and monitor all patients receiving OPANA® ER for the development of these behaviors and conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as OPANA® ER, but use in such patients necessitates intensive counseling about the risks and proper use of OPANA® ER, along with intensive monitoring for signs of addiction, abuse, and misuse.
  • Abuse or misuse of OPANA® ER by crushing, chewing, snorting, or injecting the dissolved product will result in the uncontrolled delivery of the oxymorphone and can result in overdose and death.
  • Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing OPANA® ER. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug. Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product.

Life-threatening Respiratory Depression

  • Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended. Respiratory depression from opioid use, if not immediately recognized and treated, may lead to respiratory arrest and death. Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient's clinical status. Carbon dioxide (CO2) retention from opioid- induced respiratory depression can exacerbate the sedating effects of opioids.
  • While serious, life-threatening, or...

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