Tag Archives: Painkillers

Snail Venom Has Potential to Create Powerful New Painkillers

Though still in the research phase, the venom-filled treatment could produce a new class of drugs one hundred times more powerful than morphine.

Ocean-dwelling cone snails have become responsible for one of the most powerful drugs on the planet. Australian researchers have created a drug using venom from cone snails that is reportedly 100 times more powerful than morphine and “appeared to significantly reduce pain.”

The Sydney Morning Herald has noted that the still-unnamed drug doesn’t have the addictive components of other painkillers. The primary ingredient in the drug is conotoxin, a compound secreted by cone snails.

But as of now, it has only been tested on rats and a human trial is still two years away. “We don’t know about side effects yet, as it hasn’t been tested in humans. But we think it would be safe,” said lead researcher David Craik of the University of Queensland in Australia. The goal of the drug is to manage neuropathic pain, which affects 15 percent of the U.S. population and can arise from cancer, AIDS, diabetes, and other debilitating diseases.

Craik thinks that the venom-filled treatment could open up a “whole new class of drugs capable of relieving one of the most severe forms of chronic pain that is currently very difficult to treat.” A painkiller with conotoxin called ziconotide has already been approved for human use, but is not available in pill form and requires a spinal cord injection.

New ‘Abuse Resistant’ Painkiller May Torpedo Zohydro

The news of Purdue Pharma’s intention to rival Zohydro has caused the drug’s maker, Zogenix, to see its stock drop by more than 20 percent.

The makers of OxyContin have delivered a potentially devastating blow to the controversial new drug Zohydro – which produces an effect five to 10 times stronger than Vicodin – by revealing that they plan to submit an “abuse-resistant” painkiller to the Food and Drug Administration.

Purdue Pharma, which created MS Contin in 1984 and OxyContin in 1996, completed testing on a version of hydrocodone that cannot be crushed so abusers can snort or inject the drug. The new painkiller will be submitted to the FDA later this year, but it has already had a negative impact on Zohydro and its maker, Zogenix, which experienced a drop in shares by more than 20 percent following Purdue’s announcement.

The news is the latest in a series of public condemnations from the medical community directed toward Zohydro, a pure form of hydrocodone which was approved by the FDA in 2013 despite a lack of an abuse-deterrent formulation – an additive like naloxone or niacin which would cause an adverse effect if ingested by injection or snorting, but would remain inactive if consumed orally and absorbed into the gastrointestinal tract. The agency even ignored an 11-2 vote against approving the drug by their own scientific advisory panel.

The decision spurred a letter of protest from more than 40 doctors, addiction specialists, and lawmakers urging the FDA to reconsider its decision, given the recent overwhelming rate of painkiller addiction across the United States and elsewhere, as well as the inherent dangers of the drug. In the letter, the authors said that Zohydro is powerful enough to cause a fatal overdose in a person unaccustomed to taking opioids with just two capsules.

One of the letter’s signatories, Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing, summed up the drug’s potential by stating, “It will kill people as soon as it’s released.” In response, Zogenix has posted a warning about the drug’s potential side effects on its site and established an external safe-use board to oversee “appropriate use” of Zohydro.

FDA approves a powerful new opioid painkiller

Addiction experts protested loudly when the Food and Drug Administration approved a powerful new opioid painkiller last month, saying that it would set off a wave of abuse much as OxyContin did when it first appeared. An F.D.A. panel had earlier voted, 11 to 2, against approval of the drug, Zohydro, in part because unlike current versions of OxyContin, it is not made in a formulation designed to deter abuse.

Now a new issue is being raised about Zohydro. The drug will be manufactured by the same company, Alkermes, that makes a popular medication called Vivitrol, used to treat patients addicted to painkillers or alcohol. In addition, the company provides financial support to a leading professional group that represents substance abuse experts, the American Society of Addiction Medicine.

For some critics, the company’s multiple roles in the world of painkillers is troubling.

Dr. Gregory L. Jones, an addiction specialist in Louisville, Ky., said he had long been concerned about financial links between the group and the drug industry, adding that the Zohydro situation amplified those potential conflicts.

Dr. Stuart Gitlow, the current president of the American Society of Addiction Medicine, said he had been unaware until now of Alkermes’s involvement with Zohydro. Dr. Gitlow, who is affiliated with Mount Sinai Hospital in New York City, said that the group would seek more information from Alkermes about the situation and then decide what, if anything, to do next.

Officials of Alkermes appear to recognize the issue they face. In recent years, the company has been trying to increase sales of Vivitrol, a form of a drug called naltrexone, that is used to treat both alcoholism and opioid addiction.

In a statement, Rebecca Peterson, a spokeswoman for Alkermes, said the company was “evaluating its role with respect to Zohydro” as a result of the drug’s approval. She declined to elaborate.

The tie between Alkermes and Zohydro had not drawn attention because the company did not initially own the drug, nor was it apparently involved in the efforts to get it approved in the United States.

A small California-based company called Zogenix purchased the right to market Zohydro in the United States from another drug maker, Elan. Then a year later, in 2011, Alkermes bought a unit of Elan that included Zohydro, among other products, and inherited the existing agreement with Zogenix.

In their presentation to the F.D.A., officials of Zogenix said they would closely monitor the drug’s use for signs that it was being abused and quickly move to stop such problems. Agency officials said they had approved the drug to give doctors another long-acting opioid to use when treating patients with chronic pain. A few days after the drug’s approval, Zogenix announced that it had signed an agreement with another company, Altus Formulation, under which Altus would develop a formulation of Zohydro that was less vulnerable to abuse than the one just approved.

The development of drug formulations that are less prone to abuse can take years and are not always successful. Currently, drugs like OxyContin are designed so their consistency changes when they are crushed, making them difficult to inject or snort.

Zogenix began running a clinical trial of Zohydro in 2010. In a statement, the company’s president, Dr. Stephen J. Farr, said that the F.D.A. only recently laid out guidelines for the types of features it would like to see in opioid formulations that deter abuse. “Zogenix is fully engaged in efforts to bring an abuse-deterrent-form formulation of Zohydro,” to market, he said.

Dr. Andrew J. Kolodny, the chief medical officer of Phoenix House, which runs drug and alcohol treatment centers in 10 states, said he believed that the American Society of Addiction Medicine should not take money from a company whose product would most likely worsen this country’s drug abuse problem. In addition, Dr. Kolodny, who is a member of the group, said that while Phoenix House will continue to use Vivitrol when appropriate to treat patients, Alkermes officials will find the door closed. “Representative of Alkermes are not welcome,” he said.

Narcotic painkillers fail to improve pain control

A new study finds that despite a decade of extensive prescription opioid use, the identification and treatment of pain has failed to improve.

Experts say use of prescription opioid analgesics has reached epidemic levels with the benefit of the prescriptions questionable. “There is an epidemic of prescription opioid addiction and abuse in the United States,” said G. Caleb Alexander, M.D., M.S., co-director of the Johns Hopkins Center for Drug Safety and Effectiveness. “We felt it was important to examine whether or not this epidemic has coincided with improved identification and treatment of pain.”

Alexander and his fellow researchers used the National Ambulatory Medical Care Survey, designed to analyze trends from 2000 to 2010 associated with patients seeking medical treatment for non-cancer pain. They found no significant change in the proportion of pain visits — approximately one-half – treated with pain relievers.

During this time, non-opioid (analgesic) prescriptions remained stable, consisting of 26-29 percent of pain visits. However, opioid (morphine-related) prescriptions nearly doubled, from 11 percent in 2000 to 19 percent in 2010. Of approximately 164 million pain visits in 2010, roughly half were treated with some kind of pain relieving drug: 20 percent with an opioid and 27 percent with a non-opioid pain reliever.

Alexander and colleagues also examined visits for new-onset musculoskeletal pain, and in spite of similar increases in opioid prescribing, the results showed a significant decrease in non-opioid analgesics prescriptions.

Researchers found a 38 to 29 percent drop between 2000 and 2010, despite a lack of evidence showing opioids are more effective or safer than non-opioid treatments for such pain. Chronic pain affects nearly 100 million U.S. adults and carries major costs in terms of health care and lost productivity.

Initiatives designed to increase patient and provider awareness of pain have come with unintended consequences. Prescription opioid abuse has been increasingly documented in emergency department visits and deaths.

“By 2008, the annual number of fatal drug poisonings surpassed those of motor vehicle deaths and overdose deaths attributable to prescription drugs exceeded those of cocaine and heroin combined,” Alexander and colleagues noted.

The new study is one of the first to focus on trends in pain treatment in ambulatory care—that is, office and clinic visits. Experts say the results highlight the importance of balancing the risks and benefits of analgesics prescribed in the primary care setting.

“The majority of pain medications are prescribed by primary care physicians, who treat over half of the chronic pain in the United States,” said Matthew Daubresse, M.H.S., lead author of the report. “Pain specialists only treat a fraction of these patients.”

“We found that not only have the rates of treated pain not improved, but in many cases, use of safer alternatives to opioids, such as medicines like ibuprofen and acetaminophen, have either stayed flat or declined,” said Alexander.

“This suggests that efforts to improve the identification and treatment of pain have backfired, due to an over-reliance on prescription opioids that have caused incredible morbidity and mortality among patients young and old alike.”

In response to the growing opioid epidemic, on September 10, the Food and Drug Administration announced new labeling changes and post-market study requirements for extended-release and long-acting opioid analgesics.

“These regulatory changes may help prescribers and patients to better appreciate the risks of these therapies,” Daubresse said. “Despite this, the ultimate impact of the FDA’s labeling change has yet to be seen.”