Impax Laboratories Launches Oxymorphone Hydrochloride Extended-Release Tablets

Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that it is commencing shipment of Oxymorphone Hydrochloride Extended-Release Tablets, through Global Pharmaceuticals, Impax’s generics division.

In June 2010, Impax reached agreement with Endo Pharmaceuticals and Penwest Pharmaceuticals (collectively Endo) to settle U.S. patent litigation with regard to the production and sale of its Oxymorphone Hydrochloride Extended-Release Tablets approved by the U.S. Food and Drug Administration (FDA) as therapeutically equivalent to the original formulation of OPANA ® ER. Under the terms of the settlement, Endo agreed to grant Impax a license to sell Impax’s approved product on January 1, 2013.

As a company whose mission is to provide high quality, lower-cost prescription drugs, Impax is actively participating in efforts to support prescriber and patient education of this product through the FDA-approved Risk Evaluation and Mitigation Strategy (REMS).

Oxymorphone Hydrochloride Extended-Release Tablets are indicated for the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time.

IMPORTANT RISK INFORMATION

Oxymorphone Hydrochloride Extended-Release Tablets, for oral use, CII

BRIEF SUMMARY

WARNING: ABUSE POTENTIAL, LIFE-THREATENING RESPIRATORY DEPRESSION, ACCIDENTAL EXPOSURE, and INTERACTION WITH ALCOHOL

Abuse Potential Oxymorphone hydrochloride extended-release tablets contains oxymorphone, an opioid agonist and Schedule II controlled substance with an abuse liability similar to other opioid agonists, legal or illicit [see Warnings and Precautions]. Assess each patient’s risk for opioid abuse or addiction prior to prescribing oxymorphone hydrochloride extended-release tablets. The risk for opioid abuse is 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 depressive disorder). Routinely monitor all patients receiving oxymorphone hydrochloride extended-release tablets for signs of misuse, abuse, and addiction during treatment .

Life-threatening Respiratory Depression Respiratory depression, including fatal cases, may occur with use of oxymorphone hydrochloride extended-release tablets, even when the drug has been used as recommended and not misused or abused. Proper dosing and titration are essential and oxymorphone hydrochloride extended-release tablets should only be prescribed by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain. Monitor for respiratory depression, especially during initiation of oxymorphone hydrochloride extended-release tablets or following a dose increase . Instruct patients to swallow oxymorphone hydrochloride extended-release tablets whole. Crushing, dissolving, or chewing oxymorphone hydrochloride extended-release tablets can cause rapid release and absorption of a potentially fatal dose of oxymorphone.

Accidental Exposure Accidental ingestion of oxymorphone hydrochloride extended-release tablets, especially in children, can result in a fatal overdose of oxymorphone.

Interaction with Alcohol The co-ingestion of alcohol with oxymorphone hydrochloride extended-release tablets may result in an increase of plasma levels and potentially fatal overdose of oxymorphone. Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while on oxymorphone hydrochloride extended-release tablets.

INDICATIONS AND USAGEOxymorphone hydrochloride extended-release tablets are indicated for the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time.

Limitations of UsageOxymorphone hydrochloride extended-release tablets are not intended for use:
  • As an as-needed (prn) analgesic
  • For pain that is mild or not expected to persist for an extended period of time
  • For acute pain
  • For postoperative pain unless the patient is already receiving chronic opioid therapy prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time.

CONTRAINDICATIONSOxymorphone hydrochloride extended-release tablets are contraindicated in patients with:
  • Significant respiratory depression
  • Acute or severe bronchial asthma or hypercarbia
  • Known or suspected paralytic ileus
  • Moderate and severe hepatic impairment
  • Hypersensitivity (e.g. anaphylaxis) to oxymorphone, any other ingredients in oxymorphone hydrochloride extended-release tablets, or to morphine analogs such as codeine.

WARNINGS AND PRECAUTIONS Abuse PotentialOxymorphone hydrochloride extended-release tablets contains oxymorphone, an opioid agonist and a Schedule II controlled substance. Oxymorphone can be abused in a manner similar to other opioid agonists, legal or illicit. Opioid agonists are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing oxymorphone hydrochloride extended-release tablets in situations where there is concern about increased risks of misuse, abuse, or diversion. Concerns about abuse, addiction, and diversion should not, however, prevent the proper management of pain.

Assess each patient’s risk for opioid abuse or addiction prior to prescribing oxymorphone hydrochloride extended-release tablets. The risk for opioid abuse is 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). Patients at increased risk may still be appropriately treated with modified-release opioid formulations; however these patients will require intensive monitoring for signs of misuse, abuse, or addiction. Routinely monitor all patients receiving opioids for signs of misuse, abuse, and addiction because these drugs carry a risk for addiction even under appropriate medical use.

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