Category Archives: Analgesics

FDA greenlights first non-opioid therapy to manage symptoms of opioid withdrawal

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As the opioid epidemic continues to grip the US as the leading cause of deaths in those under the age of 50, the FDA has made an important leap with the approval of Lucemyra (lofexidine hydrochloride) for managing the symptoms of opioid withdrawal in adult patients – the first non-opioid therapy for this purpose.

While this is an important step forward, the therapy is not a cure-all solution and is not guaranteed to prevent withdrawal symptoms and may only lessen their severity, and is only approved for use for up to 14 days. These symptoms can include anxiety, muscle aches, agitation, sweating, nausea, vomiting, problems sleeping and drug cravings, which can occur both in patients with opioid use disorder and in those using the drugs as directed by a medical professionals.

An oral, selective alpha 2-adrenergic receptor agonist, Lucemyra works by reducing the release of norepinephrine, which is thought to be a key element in the symptoms of opioid withdrawal. The regulator’s decision was based on two trials of 866 patients who met the Diagnostic and Statistical Manual-IV criteria for opioid dependence who were physically dependent on opioids and undergoing abrupt opioid discontinuation. In these trials, it was found that patients taking Lucemyra reported lower severity of withdrawal symptoms according to the Short Opiate Withdrawal Scale of Gossop.

The fast-tracked decision comes off the back of a positive opinion in March from an independent FDA advisory committee. The regulator also specified that it requires 15 postmarketing studies to be conducted to support the drug’s longer-term use.

“As part of our commitment to support patients struggling with addiction, we’re dedicated to encouraging innovative approaches to help mitigate the physiological challenges presented when patients discontinue opioids,” said FDA Commissioner Scott Gottlieb. “We’re developing new guidance to help accelerate the development of better treatments, including those that help manage opioid withdrawal symptoms. We know that the physical symptoms of opioid withdrawal can be one of the biggest barriers for patients seeking help and ultimately overcoming addiction. The fear of experiencing withdrawal symptoms often prevents those suffering from opioid addiction from seeking help. And those who seek assistance may relapse due to continued withdrawal symptoms. The FDA will continue to encourage the innovation and development of therapies to help those suffering from opioid addiction transition to lives of sobriety, as well as address the unfortunate stigma that’s sometimes associated with the use of medication-assisted treatments.”


Three medicines step closer to EU approval

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Three medicines treating HIV, pain and cancer have been recommended for approval by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) at its latest meeting.

Gilead’s Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) was endorsed as a treatment HIV-1 infection.

The once-daily single tablet regimen has shown high rates of virologic suppression and no treatment-emergent resistance through 48 weeks in Phase III clinical trials involving treatment-naïve adult patients and among virologically suppressed adults who switched regimens.

The marketing application contains data from four Phase III studies in which the regimen met its primary goal of non-inferiority to ViiV Healthcare’s flagship drug dolutegravir (DTG) at 48 weeks.

The therapy was approved in the US in February.

The CHMP also recommended approval of one hybrid medicine, FGK Representative Service GmbH’s Dzuveo (sufentanil), for the treatment of pain.

Hybrid applications rely in part on the results of preclinical tests and clinical trials for a reference product and in part on new data.

The opioid produces analgesia by activating μ-opioid receptors primarily within the central nervous system, and its most common side effects are nausea, vomiting and pyrexia.

Elsewhere, the Committee voiced its support for Obvius Investment BV’s generic medicine Carmustine Obvius (carmustine), for the treatment brain tumours, non-Hodgkin’s lymphoma and Hodgkin’s disease.


Medicinal cannabis is safe and effective — it’s time to reboot research

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Researchers are calling for medicinal cannabis to be properly established in our modern medical arsenal.

Researchers claim that medicinal cannabis is safe and effective in pain relief, and are calling for the treatment to be properly established in our modern medical arsenal.

Cannabis has been used for centuries in pain relief, as a sleep aid and for many other purposes, yet there is little evidence on its safety and effectiveness. This is in part due to relatively recent legal restrictions on its use, which have hampered research efforts and resulted in doctors having little to no understanding of its use.

However, there has been an explosion in the number of studies published since 2012. The review provides two major studies on the use of cannabis in cancer patients and the elderly, as well as a comprehensive overview of the evidence, regulations, ethics and practical use. The authors and editors call for more research to improve the evidence base.

In a study led by Professor Victor Novack, A Professor at Ben-Gurion University of the Negev in Israel a team of researchers analysed data collected during the medicinal cannabis treatment of 2,970 cancer patients between 2015 and 2017. The two main problems patients were hoping to overcome were sleep problems and pain, and cannabis has been shown to be effective in alleviating both 95.9 percent of the patients reported an improvement in their condition.

The same team also analysed the effectiveness of medical cannabis in elderly patients who were being treated in 2015-2017 for a variety of issues, including pain and cancer. The researchers conclude in their paper: “Our study finds that the therapeutic use of cannabis is safe and efficacious in the elderly population. Cannabis use may decrease the use of other prescription medicines, including opioids. Gathering more evidence-based data, including data from double-blind randomised controlled trials, in this special population is imperative.”

In a review Professor Donald Abrams at University of California San Francisco Ward covers 10,000 scientific abstracts, “concluded that there was conclusive or substantial evidence that cannabis or cannabinoids are effective for the treatment of pain in adults; chemotherapy-induced nausea and vomiting and spasticity associated with multiple sclerosis.”

Yet the report also highlighted the barriers to research in the US, which may explain the lack of strong evidence for the therapeutic use of cannabis. This dearth of research has also led to numerous ethical issues in prescribing cannabis, not least because many doctors do not understand the treatment enough to advise dosage and use. An article by researchers at the University of British Columbia, Canada and International Cannabis and Cannabinoids Institute, Prague, Czech Republic provides practical guidance for doctors, with data on cannabis pharmacology.

“We feel it is absolutely imperative to not only present the current state of affairs but also propose the development of the scientific research program within the paradigm of evidence-based medicine,” said Prof Novack,  “Our ultimate aim should be to scientifically establish the actual place of medical cannabis-derived products in the modern medical arsenal.”


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.