FDA approves updated label for Pfizer’s Embeda
BY Ryan Chavis
NEW YORK — Pfizer last week announced that the Food and Drug Administration approved a revised label for Embeda (morphine sulfate and naltrexone hydrochloride) extended-release capsules, for oral use, CII, to include abuse-deterrence studies.
The revised label states that the drug has properties expected to curb abuse via oral and intranasal routes when crushed, though abuse of the drug is still possible. The updated label also incorporates data from a human abuse potential study of intravenous (IV) morphine and naltrexone to simulate crushed Embeda, the company stated.
Embeda is indicated for treatment for pain that is severe enough to require daily, long-term opioid treatment when alternative treatment plans have proven inadequate. Pfizer said it expects the drug to be available in the United States in early 2015.
“Prescription opioids are an important treatment option for people with chronic pain. However, misuse and abuse of opioids in the U.S. is a serious societal concern, which is why the development of abuse-deterrent formulations of these medicines is a high priority,” said Bob Twillman, Ph.D.,director of policy and advocacy, American Academy of Pain Management. “All opioid medications, including morphine products, have the potential for abuse. We believe that anything that can be done to reduce this risk is a significant development for healthcare providers and their patients.”
From 1999 to 2010, the number of fatal overdoses involving prescription painkillers quadrupled, with more than 16,000 deaths in 2010, according to the Centers for Disease Control and Prevention. In 2012, the National Survey on Drug Use and Health showed that more than 12 million people in the United States used prescription painkillers for non-medical purposes in the previous year. Seventy percent of those using non-medical prescription opioids got them from a friend or relative.
“More than one-third of extended-release opioids prescribed are morphine, and Embeda is the first extended-release morphine with the potential to reduce abuse via the oral and intranasal routes when crushed,” said Dr. Steven Romano, SVP and head, Medicines Development Group, Pfizer Global Innovative Pharmaceutical Business. “Pfizer believes that abuse-deterrent products like Embeda are important to help address the growing public health problem of opioid abuse in the U.S.”
Ricola’s new product offers energy boost
BY Ryan Chavis
PARSIPPANY, N.Y. — Ricola, a manufacturer of herb drops, on Wednesday announced the introduction of Revitalizing Herb Drops, which work to restore energy. The drops contain a powder-filled center with B-vitamins to help give consumers a natural boost when they have a cough or cold, the company said.
"By adding Vitamin B we've created a truly unique herb drop that provides soothing relief and a naturally effective energy boost to help people get through their busy work day, even when they're not feeling well," says Joahne Carter, VP marketing and innovation at Ricola. "Our Revitalizing Herb Drops offer natural relief because they're created from the same blend of Swiss alpine herbs that we have been using for the past 80 years."
Available in a lemon zest flavor, Ricola's Revitalizing Herb Drops are now available at major retailers for a suggested retail price of $3.29 for an 18-count pack.
Drug Channels: Walmart, Walgreens dominate 2015 Medicare Part D preferred networks
PHILADELPHIA — Drug Channels on Tuesday released a report showing that Walmart and Walgreens dominate 2015 Medicare Part D preferred networks, followed by independent pharmacy.
"Walmart again leads the pack in preferred network participation," wrote Adam Fein, president of Pembroke Consulting and writer of the Drug Channels blog. "Walgreens has a big bet on preferred networks, while CVS and Rite Aid have been more cautious. Independent pharmacies feature prominently in many plans, which should — but probably won't — mute critics of preferred networks."
Based on online plan summary information, Drug Channels developed a table that summarizes the top seven retail pharmacy chains’ participation in major preferred networks.
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