FDA requiring changes in opiate pain killers

  1. beentheredonethatagain
    FDA seeks plans to reduce misuse of painkillers
    Published - Feb 09 2009 02:02PM PST

    By MATTHEW PERRONE - AP Business Writer
    Federal health regulators are requiring more than a dozen drugmakers to develop plans to reduce the misuse of their painkillers, which cause hundreds of deaths each year.

    The Food and Drug Administration said Monday it has issued letters to companies that make 24 opioid drugs, including morphine, oxycodone and methadone. Opioids are drugs that simulate the effects of natural opiates, such as opium poppy.

    The products targeted by FDA, which come in both pill and patch forms, generally feature extended-release formulas designed to give long-lasting effects. But regulators warned that potency carries serious risks.

    "We're focusing on these products because they generally contain very high doses of the drugs and need to be used very carefully," said Dr. John Jenkins, FDA's chief of new drugs.

    The drugs are typically used by people already taking narcotics, such as cancer patients, to treat severe flare-ups of pain. Despite their ability to relieve chronic pain the drugs can be highly addictive and are often abused for their euphoric effects.

    The FDA has issued a number of warnings on prescription pain relievers in recent years and some companies already have plans to manage the drugs' risks.

    "Despite these efforts, the rates of misuse and abuse, and of accidental overdose of opioids, have risen over the past decade," said Jenkins. According to FDA, about 3.7 million patients were taking the drugs under scrutiny in 2007.

    A federal survey conducted that year found 5.2 million people in the U.S. reported using prescription pain drugs inappropriately.

    "This is an ongoing problem that's getting worse," said Bob Rappaport, head of FDA's anesthesia drugs division.

    FDA said it will meet with 16 drugmakers March 3 to discuss risk-management plans for the medications. Such plans can include bolstered warning labeling, restrictions on patients who can receive the drugs and cautionary letters to physicians.

    Companies asked to attend include makers of generic pills as well as brand-name products, like Johnson & Johnson's Duragesic patch, King Pharmaceuticals' extended-releases Avinza pills and Purdue Pharma's extended-release OxyContin.

    The risk-managing plans are unlikely to appear until later this year, as FDA said it hopes to hold a public meeting to gather opinions on the issue in the late spring or summer. Until then, regulators said physicians should be diligent about prescribing the drugs only where appropriate.

    Regulators said continuing deaths from the drugs are due to both abuse by patients and inappropriate prescribing by physicians. The agency has documented many cases of physicians prescribing the potent painkillers for patients with migraine headaches, an unapproved use.

    The FDA said patients will also sometimes chew extended-release pills that are designed to be swallowed, causing an overdose of the drug.

    The FDA only gained the power to require risk-management plans in 2007, after Congress passed a law designed to improve drug safety. Previously the agency negotiated any changes to drug labeling and promotion with manufacturers.

    Regulators are reviewing two experimental painkillers designed to discourage abuse.

    King Pharmaceuticals has asked the FDA to approve the drug Embeda, which it acquired through the purchase of Alpharma, as a tamperproof version of morphine for patients with chronic pain.

    The pills are formulated so that the euphoric effects of morphine are blocked when a patient crushes, dissolves or chews them. Drugmaker Pain Therapeutics, based in San Mateo, Calif., is waiting for an agency decision on its own abuse-resistant version of oxycodone. The drug was developed in partnership with King.

    FDA said its announcement Monday only applies to companies with drugs already on the market.

    Share This Article


  1. old hippie 56
    Already hard to get opiates for pain management. Talking with some friends that was having trouble finding a pain doctor that takes Medicare or Medicaid.
  2. gilligan_911
    So swim went and read that the FDA had to say about this and on the list of 24 opiates that are going to be under REMS, and correct swim if hes wrong, the Teva/Impax Oxycodone 'anti-abuse' ER pills which are made to stop people from abusing them were discontinued. shouldnt the pills that discourage/prevent abuse be marketed more and others less? (but swims not complaining that its the other way around;))

    In the NYtimes paper the FDA director, John Jenkins, said that the current restrictions that were in place failed to "fully meet the goals we want to achieve". and that there should be a more strict regulation for how the Schedule II opiates like Hydromorphone, Fentanyl, Oxycodone, Methadone and Morphine be perscribed and distributed.

    Now people with real pain cant just go to their regular doctor to get their next refill. swim does suppose that this will help on cutting down the wrongful perscriptions of these drugs but they will hurt some of those that need scripts. seems like the gov't will stop at nothing to get the opiates out of the hands of those greedy criminal drug abusers eh? and if they so happen to kill a few innocent bystanders... they died for the common good. god bless america.
  3. beentheredonethatagain
    New guidelines for prescribing opioid pain drugs published
    19:00 ,Medicine & Health

    A prestigious panel of pain-management experts representing the American Pain Society (APS) www.ampainsoc.org and the American Academy of Pain Medicine (AAPM) has published the first comprehensive clinical practice guideline to assist clinicians in prescribing potent opioid pain medications for patients with chronic non-cancer pain. The long-awaited guideline appears in the current issue of The Journal of Pain, www.jpain.org, the APS peer-reviewed publication.


    "The expert panel concluded that opioid pain medications are safe and effective for carefully selected, well-monitored patients with chronic non-cancer pain," said Gilbert J. Fanciullo, MD, a panel co-chair and director, Section of Pain Medicine, Dartmouth Hitchcock Medical Center.
    APS, AAPM and the Oregon Evidence-based Practice Center at Oregon Health and Science University collaborated for two years reviewing more than 8,000 published abstracts and non-published studies to assess clinical evidence from which their recommendations are based.

    The target audience is clinicians who care for adults with chronic non-cancer pain.
    The panel made 25 specific recommendations and achieved unanimous consensus on nearly all. "The guidelines are based on the available evidence and also rely on an underlying assumption that chronic opioid therapy requires prescribers to have clinical skills and knowledge in both the principles of opioid treatment and the assessment and management of risks associated with opioid abuse, addiction and diversion," said Fanciullo.

    Opioid prescribing has increased significantly due to growing professional acceptance that the drugs can relieve chronic non-cancer pain, and the guideline acknowledges there are widespread concerns about increases in prescription opioid abuse, addiction and diversion.

    "Decisions about chronic opioid therapy must weigh the benefits of these medications against the risks, which include side effects and adverse outcomes associated with abuse," said Perry Fine, MD, panel co-chair and professor of anesthesiology, University of Utah Medical Center.

    Opioids, such as morphine, oxycodone, oxymorphone and fentanyl are potent analgesics. They traditionally have been used to relieve pain following surgery, from cancer and at the end of life. Today opioids are used widely to relieve severe pain caused by chronic low-back injury, accident trauma, crippling arthritis, sickle cell, fibromyalgia, and other painful conditions.

    Prior to initiating chronic opioid therapy, the guideline advises clinicians to determine if the pain can be treated with other medications. If opioids are appropriate, the clinician should conduct a thorough medical history and examination and assess potential risk for substance abuse, misuse or addiction.

    Fanciullo noted the strongest predictor of possible drug misuse is a personal or family history of alcohol and drug abuse. "For patients at higher risk for misuse of opioids, the guideline advises giving patients clear written rules, such as filling prescriptions at one pharmacy only, taking random drug tests, making regular physician visits, and locking their medications at home," he said.

    Diligent Patient Monitoring Is Essential
    A key recommendation urges clinicians to continuously assess patients on chronic opioid therapy by monitoring pain intensity, level of functioning and adherence to prescribed treatments. Periodic drug screens should be ordered for patients at risk for aberrant drug behavior.

    "Regular monitoring of chronic opioid therapy patients is warranted because the therapeutic benefits of these medications are not static and can be affected by changes in the underlying pain condition, coexisting disease, or in psychological or social circumstances," said Fanciullo. "For patients at low risk for adverse outcomes and on stable doses of opioids, monitoring at least once every three to six months is sufficient, but weekly monitoring is justifiable for those at high risk for abuse and other adverse events."

    Fine added that sometimes patient self reports are unreliable, so the guideline recommends that pill counts, urine drug screening, family member or caregiver interviews and prescription monitoring data be used to check for possible abuse. "Although strong evidence is lacking on the best methods for managing high-risk patients, potential risks can be minimized by more frequent and intense monitoring compared to lower risk patients," he said.

    Other recommendations in the APS/AAPM clinical practice guideline include:
    Methadone: Use of methadone for pain management has increased dramatically but few trials have evaluated its benefits and harms for treatment of chronic non-cancer pain.

    Methadone, therefore, should be started at low doses and titrated slowly. Because of its long half-life and variable pharmacokinetics, the panel recommends methadone not be used to treat breakthrough pain or as an as-needed medication.

    Abusers: Chronic opioid therapy must be discontinued in patients known to be diverting their medication or in those engaging in serious aberrant behaviors.
    Breakthrough Pain: As-needed opioids can be prescribed based on initial and ongoing analysis of therapeutic benefit versus risk.

    High Doses: Patients who need high doses of opioids (200 mg daily of morphine or equivalent) should be evaluated for adverse events on an ongoing basis. Clinicians should consider rotating pain medications when patients experience intolerable side effects or inadequate benefit despite appropriate dose increases.

    Driving and Work Safety: Patients should be educated about the greater risk for impairment when starting chronic opioid therapy and counseled not to drive or engage in potentially dangerous work if impaired.
    Pregnancy: Clinicians should counsel women about risks in pregnancy and encourage minimal or no use of chronic opioid therapy unless potential benefits outweigh risks.

    The guideline on opioid therapy for chronic non-cancer pain is the sixth evidenced-based, pain management clinical practice guideline published by APS. Others have covered sickle-cell disease, arthritis, cancer, fibromyalgia, and low back pain.
    "This is a milestone collaboration in which two leading organizations representing pain management have developed the first comprehensive, evidence-based clinical practice guideline to assist clinicians in managing chronic opioid therapy," said APS President Charles Inturrisi, PhD. "We are grateful to the American Academy of Pain Medicine for joining forces with APS in developing this long-awaited publication."
    Source: American Pain Society
  4. Niteflights
    This is a blatant move by big pharma to eliminate non synthetic/patentable competition. They are doing it with vitamins and herbs also.
  5. Electrolingus
    Embeda has now been approved by the FDA.

    FDA Approves EMBEDA(TM) For Management of Moderate to Severe Chronic Pain

    King Pharmaceuticals, Inc, today announced that the U.S. Food and Drug Administration (FDA) has approved EMBEDA(TM) (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules for oral use, a long-acting Schedule II opioid analgesic for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. EMBEDA(TM) is the first FDA-approved long-acting opioid that is designed to reduce drug liking and euphoria when tampered with by crushing or chewing.

    "Today's approval of EMBEDA(TM) marks a milestone in pain care, and King is proud to bring this new technology to the U.S. market," said Brian A. Markison, Chairman, President, and Chief Executive Officer of King. "King is committed to providing resources and medicines to patients and healthcare professionals to achieve optimal pain control. We are focused on developing medicines that use novel technologies designed to reduce drug liking and make it more difficult to extract the active ingredient. We anticipate a September 2009 launch for EMBEDA(TM)."

    Utilizing King's proprietary technology, EMBEDA(TM) contains extended-release morphine pellets, each with an inner core of naltrexone hydrochloride, an opioid receptor antagonist. If taken as directed, the morphine relieves pain while the sequestered naltrexone hydrochloride passes through the body with no intended clinical effect. If EMBEDA(TM) is crushed or chewed, the naltrexone is released and absorbed with the morphine, reversing the morphine's subjective and analgesic effects. The clinical significance of the degree of this reduction has not been established, and there is no evidence that the naltrexone in EMBEDA(TM) reduces the abuse liability of EMBEDA(TM).

    "The development of formulations like EMBEDA(TM) that employ technologies designed to reduce drug liking and euphoria associated with non-medical uses could potentially change how chronic pain is treated. Prescribers and patients have been hoping and waiting for safer medicines to treat chronic pain," said Nathaniel Katz, M.D., M.S., President of Analgesic Research and Adjunct Assistant Professor, Tufts University.

    Markison added, "In addition to EMBEDA(TM), King is developing a portfolio of long- and short-acting opioid pain medications and technologies that are designed to offer treatment while reducing potential risks of unintended uses. We believe that we could be well positioned to treat a wide range of patients with products designed to address this important societal issue."

    An estimated 50 million Americans live with chronic pain, a serious, undertreated public health problem. Opioids provide effective pain management and are especially useful in treating appropriately selected patients with moderate to severe chronic pain who have not responded adequately to other pain management therapies.

    Clinical Trial Data to Support EMBEDA(TM)
    The FDA approval was based on data from 12 clinical studies of EMBEDA(TM), including phase III data demonstrating efficacy and safety. In a phase III study, EMBEDA(TM) provided significant pain relief in patients with moderate to severe pain due to osteoarthritis of the hip or knee compared with placebo. Additionally, an earlier phase II study found EMBEDA(TM) was bioequivalent to another marketed extended-release morphine sulfate capsule product.

    Phase III findings also showed that EMBEDA(TM) was safe and well tolerated in patients treated for up to 12 months, with an overall safety profile consistent with the most common opioid-related adverse events. The most common adverse events reported in the EMBEDA(TM) clinical program were consistent with the well-known adverse reactions associated with morphine, including constipation, nausea, and somnolence.

    The data also showed that sequestered naltrexone hydrochloride did not compromise the safety and efficacy of the morphine. In a separate study of recreational drugs users, EMBEDA(TM), when crushed and taken orally, was shown to have reduced drug liking and euphoria compared with an equivalent dose of immediate-release morphine sulfate solution. The clinical significance of the degree of reduction in drug liking and euphoria reported in these studies has not yet been established. There is no evidence that the naltrexone in EMBEDA(TM) reduces the abuse liability of EMBEDA(TM).

    About EMBEDA(TM)
    EMBEDA(TM) (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules is a long-acting Schedule II opioid analgesic that is indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. EMBEDA(TM) is an extended-release form of morphine intended for once- or twice-daily dosing. Because EMBEDA(TM) is an extended-release product; it should not be chewed, crushed, or dissolved due to the risk of rapid release and absorption of a potentially fatal dose of morphine. EMBEDA(TM) is NOT intended for use as a prn analgesic, and it is not indicated for postoperative use.

    Important Safety Information for EMBEDA(TM)
    EMBEDA(TM) (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules is a prescription medicine used to treat moderate to severe pain that continues around the clock and is expected to last for a long period of time. EMBEDA(TM) is not for use to treat pain as needed. EMBEDA(TM) contains morphine a Schedule II controlled substance. Morphine is a strong opioid pain medicine that can be abused by people who abuse prescription medicines or street drugs. EMBEDA(TM) contains beadlike pellets that are made up of morphine sulfate, an opioid receptor agonist (narcotic pain medicine), and naltrexone hydrochloride (HCl), an opioid receptor antagonist. The naltrexone hydrochloride within each pellet is confined or sequestered and has a special coating to protect it from being released. EMBEDA(TM) is to be swallowed whole or the contents of the capsules sprinkled on apple sauce. Do not crush, dissolve, or chew EMBEDA(TM) or the pellets in the capsules. If tampered with by crushing or chewing, the naltrexone will be released.

    Like other opioids, EMBEDA(TM) is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma or hypercapnia in unmonitored settings or in the absence of resuscitative equipment and in patients who have or are suspected to have paralytic ileus. Respiratory depression is the primary risk of opioid agonists. Respiratory depression occurs more frequently in elderly or debilitated patients.

    EMBEDA(TM) may not be right for patients who have trouble breathing or lung problems, a head injury or brain problem, liver or kidney problems, convulsions or seizures, problems urinating or prostate problems, and patients who have or have had drug abuse or drug addiction problems. Patients should be advised that EMBEDA(TM) may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Safe use in pregnancy has not been established. Prolonged use of opioid analgesics during pregnancy may cause fetal neonatal physical dependence, and neonatal withdrawal may occur.

    Individualization of dosage is essential to make optimal use of this medication. The highest dose of EMBEDA(TM) (morphine sulfate and naltrexone hydrochloride) is for "opioid tolerant" patients only. Patients should not consume alcoholic beverages or use prescription or non-prescription medications containing alcohol while on EMBEDA(TM) therapy.

    The most common side effects of EMBEDA(TM) are constipation, nausea, and sleepiness. These are not all the possible side effects of EMBEDA(TM).

    About King Pharmaceuticals, Inc.
    King, headquartered in Bristol, Tennessee, is a vertically integrated branded pharmaceutical company. King, an S&P 500 Index company, seeks to capitalize on opportunities in the pharmaceutical industry through the development, including through in-licensing arrangements and acquisitions, of novel branded prescription pharmaceutical products and technologies that complement the Company's focus in specialty-driven markets, particularly neuroscience and hospital. King's wholly owned subsidiary, Alpharma Inc., is also a leader in the development, registration, manufacture, and marketing of pharmaceutical products for food-producing animals.

    About Forward-Looking Statements
    This release contains forward-looking statements which reflect management's current views of future events and operations, including, but not limited to, statements pertaining to the development of products designed to reduce drug liking and euphoria associated with 'non-medical' uses and the potential effects of these products upon pain treatment techniques; the potential timing of the commercial launch of EMBEDA(TM); and the potential attributes or benefits of products in development. These forward-looking statements involve certain significant risks and uncertainties, and actual results may differ materially from the forward-looking statements. Some important factors which may cause actual results to differ materially from the forward-looking statements include dependence on the future level of demand for and net sales of King's products; dependence on King's ability to successfully market its products; dependence on the availability and cost of raw materials; dependence on no material interruptions in supply by contract manufacturers of King's products; dependence on the potential effect on sales of the Company's existing products as a result of the potential development and approval of a generic substitute for any such product or other new competitive products; dependence on the potential effect of future acquisitions and other transactions pursuant to the Company's growth strategy; dependence on King's compliance with FDA and other government regulations that relate to the Company's business; dependence on changes in general economic and business conditions; changes in current pricing levels; changes in federal and state laws and regulations; changes in competition; unexpected changes in technologies and technological advances; and manufacturing capacity constraints. Other important factors that may cause actual results to differ materially from the forward-looking statements are discussed in the "Risk Factors" section and other sections of King's Annual Report on Form 10-K for the year ended December 31, 2008, and its Quarterly Report on Form 10-Q for the quarter ended June 30, 2009, each of which is on file with the U.S. Securities and Exchange Commission. King does not undertake to publicly update or revise any of its forward-looking statements even if experience or future changes show that the indicated results or events will not be realized.

    To view this PRNewswire Multimedia News Release from August 13, 2009
    as well as the link to the video information and other general info.
    Go to...
To make a comment simply sign up and become a member!