Tag Archives: Opiates

New pharmaceutical product to prevent heroin deaths

A new, lifesaving product aimed at reducing the death toll from heroin abuse — developed by a professor at the University of Kentucky College of Pharmacy — is in its final round of clinical trials and has received Fast Track designation by the Food and Drug Administration.

The product, a nasal spray application of the anti-opioid drug naloxone, was developed by Daniel Wermeling, UK professor of pharmacy practice and science, through his startup company AntiOp Inc.

Naloxone is the standard treatment for suspected opioid overdose, already in use by emergency rooms and emergency medical technicians across the country. Opioids are the class of pain-killing drugs that are related to morphine, including prescription drugs such as hydrocodone and oxycodone, as well as illegal drugs such as heroin.
Currently, naloxone is administered by injection. The nasal spray eliminates the need for needles, with a ready-to-use, single-use delivery device inserted into the nose of an overdose victim. The product delivers a consistent dose, absorbed across the nasal membranes even if the patient is not breathing.

“The goal is to make the medication available to patients at high risk of opioid overdose, and to caregivers, including family members, who may lack specialized medical training,” Wermeling said. “The treatment could be given in anticipation of EMS arrival, advancing the continuum of care and ultimately saving lives.”

Nationwide, deaths from opioid overdose are on the rise, according to data from the Centers for Disease Control and Prevention. Kentucky, long troubled by widespread abuse of prescription opioids, has seen a dramatic rise in deaths from heroin overdose in recent years. In autopsies from 2013, the state medical examiner attributed 230 deaths to heroin overdose, an increase of more than 60 percent from the previous year.

UK President Eli Capilouto congratulated Wermeling on his success with AntiOp, saying that it reflects the core values of the university.

“Too many Kentucky families have experienced the tragedy of seeing a loved one’s life cut short by a drug overdose,” Capilouto said. “The epidemic of opioid abuse in our state presents an enormous and urgent challenge, not only for health care providers and law enforcement, but also for us here at the University of Kentucky. Dr. Wermeling’s project is putting a powerful new tool into the hands of those on the front line of the fight against heroin, both here in Kentucky and beyond. This type of innovation embodies the three main components of the university’s mission — education, research and, above all, service.”

UK College of Pharmacy Dean Timothy S. Tracy said Wermeling’s work also provides an illustration of “bench-to-bedside” research in action. “Dr. Wermeling’s project is a great example of how UK College of Pharmacy faculty are working each and every day to create healthier Kentucky communities,” Tracy said. “Dr. Wermeling and his collaborative team of research colleagues saw a problem facing families in Kentucky and across the nation and developed an innovative solution. That type of translational approach is important to our college, this university, and, of course, the future of our Commonwealth.”

Wermeling’s research was supported by a three-year, $3 million grant from the National Institutes of Health through the National Institute on Drug Abuse with additional funding from the Kentucky Science and Technology Corporation. In May, AntiOp partnered with Reckitt Benckiser Pharmaceuticals to accelerate production and worldwide marketing of intranasal naloxone.

The Fast Track program of the FDA is designed to expedite the development and review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track-designated drugs ordinarily qualify for priority review, thereby expediting the FDA review process.
“As an educator, pharmacist, researcher and entrepreneur, being able to work on this naloxone project has been a dream come true,” Wermeling said. “I often tell my students and colleagues that this project has allowed me to use all of the skills I have learned over the years. It has been the ultimate problem-solving project, requiring me to utilize my pharmacological skills, my drug delivery knowledge, my business and marketing skills — all at the same time.

“At the end of the day, however, this project has always been about people. It has always been about utilizing the knowledge and skills that we have to improve patient care.”

A video featuring Dr. Wermeling discussing this work may be viewed online at https://www.youtube.com/watch?v=pgjIH5KkH0k

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.”