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Pharmaceutical Approval Update.

Mary Choy

    P & T : a Peer-Reviewed Journal for Formulary Management
    |April 7, 2017
    PubMed
    Summary
    This summary is machine-generated.

    New abuse-deterrent hydrocodone bitartrate (Vantrela ER) offers long-term pain management. Etelcalcetide (Parsabiv) treats hyperparathyroidism in kidney disease patients, while deflazacort (Emflaza) addresses Duchenne muscular dystrophy.

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    Area of Science:

    • Pharmacology and Therapeutics
    • Nephrology
    • Neurology and Musculoskeletal Disorders

    Background:

    • Opioid analgesics are crucial for chronic pain, necessitating abuse-deterrent formulations.
    • Secondary hyperparathyroidism is a common complication in patients with chronic kidney disease undergoing hemodialysis.
    • Duchenne muscular dystrophy is a severe genetic disorder requiring effective therapeutic interventions.

    Purpose of the Study:

    • To review the therapeutic applications of three recently approved medications.
    • To highlight abuse-deterrent hydrocodone bitartrate (Vantrela ER) for chronic pain management.
    • To discuss etelcalcetide (Parsabiv) for secondary hyperparathyroidism and deflazacort (Emflaza) for Duchenne muscular dystrophy.

    Main Methods:

    • Review of clinical trial data and regulatory submissions for Vantrela ER, Parsabiv, and Emflaza.

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  • Analysis of pharmacokinetic and pharmacodynamic profiles related to abuse deterrence.
  • Evaluation of efficacy and safety data in target patient populations.

    • Main Results:

    • Vantrela ER demonstrates abuse-deterrent properties, potentially reducing misuse of hydrocodone bitartrate.
    • Parsabiv effectively lowers parathyroid hormone levels in hemodialysis patients with secondary hyperparathyroidism.
    • Emflaza shows clinical benefit in patients with Duchenne muscular dystrophy, improving muscle function markers.

    Conclusions:

    • These agents represent significant advancements in managing chronic pain, chronic kidney disease complications, and Duchenne muscular dystrophy.
    • Abuse-deterrent formulations like Vantrela ER are vital for safer long-term opioid therapy.
    • Parsabiv and Emflaza offer new therapeutic options for specific patient groups, improving disease management.