Category Archives: Analgesics

Migraine maven Lilly finds ‘understanding gap’ between patients, nonpatients in new survey

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Disconnects still exist in perceptions around migraines.

Surveying both migraine sufferers and average consumers, Eli Lilly found significant understanding gaps between the two.

For instance, migraine patients estimated their pain episodes lasted an average of 31 hours, while nonsufferers guessed the average fell around 21 hours. Migraine patients also rated the pain they felt much higher than the average person’s rating of what they imagined the pain to be.

“There is a huge stigma in migraine,” said Sheena Aurora, a physician who has treated migraine patients and is now a medical fellow at Eli Lilly. “… Sometimes even people with migraines don’t realize the impact of their disease. When I treated patients with migraines, I would ask them how many migraine headache days did they have, and they would have to stop and think about it.”

Lilly undertook the survey to determine migraine perceptions among three groups of people: migraine sufferers, caregivers and loved ones, and consumers who didn’t know anyone who suffers from migraines.

Other poll findings included that migraine patients feel stressed and that they’re missing out on life. Patients reported that migraines had prevented them from doing what they wanted in their lives for an average 7 days out of the previous 30 days.

During the previous year, the migraines had been severe enough to force them to miss an average of 7.4 important events, such as birthday or holiday gatherings. And an overwhelming majority—82%—agreed that it is stressful to have an unpredictable disease like migraine.

“By highlighting their unmet needs and continuing to do that, then we can help patients talk to their physicians, help physicians recognize their impact and perhaps even help payers understand the impact of migraines,” Aurora said.

She noted that the survey and other studies around migraines are important as new treatments created specifically for migraines come to market. Of the four currently FDA-approved drugs, none were designed exclusively for migraines, a fact that is often seen in low adherence when patients can’t take the side effects or don’t get enough relief, Aurora said.

Lilly is currently working to bring a new class of migraine therapy to market. The Indianapolis drugmaker has already filed a Biologics License Application with the FDA for its CGRP inhibitor maintenance drug galcanezumab, which is eventually expected to go up against contenders from companies including Amgen and Teva.

Meanwhile, Lilly’s first-in-class acute migraine candidate lasmiditan is in late-stage trials with expectations for FDA filings this year.


FDA raises death count from kratom, a natural opioid

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Facing a rising death toll associated with the use of kratom, the U.S. Food and Drug Administration said it’s overseeing the recall and destruction of a “large volume” of potentially deadly dietary supplements containing this herb, which some people believe alleviates symptoms that come with opioid withdrawal.

The action involves supplements made by Divinity Products Distribution of Grain Valley, Missouri, and distributed under brand names including Enhance Your Life and Divinity, the Food and Drug Administration said in a statement Wednesday. In cooperation with the FDA, the company agreed to stop selling products containing kratom.

“Scientific data we’ve evaluated about kratom provides conclusive evidence that compounds contained in kratom are opioids and are expected to have similar addictive effects as well as risks of abuse, overdose, and in some cases, death,” FDA Commissioner Scott Gottlieb said in the release.

“The agency has also been assessing peer-reviewed research and a growing number of adverse event reports associated with kratom use, including 44 reported deaths,” the FDA said.

The agency has for years had doubts about kratom, a plant grown in Asia. It imposed import alerts on the substance in 2012 and 2014, and in November it said it knew of 36 fatalities associated with kratom, which has no FDA-approved therapeutic uses.

“Our death count has grown from 36 to 44,” FDA spokesperson Lyndsay Meyer told CBS MoneyWatch, adding that the deaths occurred from April 2011 through December 2017. “A recent death report to us, where the person died of opioid use, the only drug in that person’s system was kratom.”

With the U.S. in the midst of an opioid epidemic, the agency is concerned that people are viewing kratom as a natural alternative to prescription drugs, when there’s little to no difference between them, Meyer said.

“People are using kratom to get off opioids, when in fact it is opioids,” she said. “Heroin comes from a plant. Just because it comes from a plant doesn’t mean it’s safe,” she added.

Additionally, the FDA said it’s probing an outbreak of salmonella infections tied to products containing kratom. The Centers for Disease Control and Prevention (CDC) on Tuesday said 28 people in 20 states have been infected and 11 hospitalized after consuming kratom in pills, powder or tea.

The CDC and FDA advised against consuming kratom — also known as thang, kakuam, thom, ketom and biak — in any form.

In November, the FDA reported that calls to U.S. poison control centers regarding kratom rose 10 times from 2010 to 2015, with hundreds of calls coming in each year.


Ibuprofen better choice over oral morphine for pain relief in children

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Widely available ibuprofen is a better choice for pain relief in children who have undergone minor surgery, as it has fewer adverse effects compared with oral morphine.

Widely available ibuprofen is a better choice for pain relief in children who have undergone minor orthopaedic outpatient surgery, as it has fewer adverse effects compared with oral morphine, according to results from a clinical trial published in the Canadian Medical Association Journal.

“This result suggests that adequate pain management should be an important goal of care, even after minor outpatient surgery, and that more effective pharmacologic and nonpharmacologic strategies should be explored,” writes Dr Naveen Poonai, Clinician Scientist, Lawson Health Research Institute, and Associate Professor, Emergency Medicine, Department of Paediatrics, Schulich School of Medicine & Dentistry, Western University, with co-authors.

The study included 154 children aged 5 to 17 years who underwent minor orthopaedic surgery, such as keyhole surgery on joints, ligament and tendon repair, suture or hardware removal at London Health Sciences Centre in London, Ontario.

In the first 24 hours, more than 80% of the children in the study needed pain relief at home. Pain scores for children in both the oral morphine and ibuprofen groups were similar, but the children receiving oral morphine reported more adverse effects, such as nausea, vomiting, drowsiness, dizziness and constipation.

“Morphine did not provide superior analgesia but was associated with significantly more adverse effects, making ibuprofen a better analgesic option,” write the authors.

They note that as neither treatment completely relieved pain, more research is needed into effective pain relief, especially for more severe pain.

Oral morphine use at home has not been previously studied in children who have had minor surgery nor has it been compared with ibuprofen.