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UK HealthCare anesthesiologist Dr. Rae Brown has led the FDA advisory committee since last year, providing expert recommendations on opioid regulation.

UK anesthesiologist brings expertise to FDA’s opioid review committee

Raeford E. Brown Jr., MD, FAAP

UK HealthCare anesthesiologist and professor Dr. Rae Brown has led the Food and Drug Administration (FDA) advisory committee since last year, providing expert recommendations on opioid regulation and developing strategies to mitigate opioid risks in society.

In July 2016, Brown was named chair of the FDA Advisory Committee on Analgesics and Anesthetics. He was nominated to serve on the committee by the Commissioner of FDA in 2015 and served on the committee for a year prior to being named chair.

The committee is composed of physicians and scientists from across the nation with expertise in anesthesiology, opioid pharmacology, clinical research and epidemiology. The advisory committee meets monthly at FDA headquarters in Silver Spring, Maryland.

Tackling the opioid crisis

During the past year, the committee has reviewed risk mitigation strategies that serve as a major agency response to the current opioid crisis. In addition, the committee has evaluated 10 abuse deterrent formulations of opioids, discussed the risks and benefits of increasing the availability of naloxone – a drug to treat opioid overdose – and reviewed the risks of codeine in the pediatric population. Brown said the committee is cautious and deliberate in scrutinizing every product reviewed for the market, as the availability of new opioids can make the ongoing epidemic in America much worse.

“My first question is, ‘Is it safe?’” Brown said of reviewing opioid deterrents presented to the committee. “Is it a safe medication for the group it is marketed to, and is it effective? My second question is, ‘Do the data support whether or not it has a real deterrent properties that are going to stand up to all the chemists in the U.S.?’ ”

Developing new clinical trials for pediatric patients

In September 2016, Brown served as the chair of an FDA symposium on the lack of clinical trials demonstrating the safety and effectiveness of opioids in infants, especially the premature. Brown, a professor of pediatric anesthesiology, is now involved in the development of an international consortium designed to provide large numbers of pediatric patients for unique safety trials.

Brown will serve as the chair of this committee for three more years. He also currently serves as the chair-elect of the Section on Anesthesiology and Pain Medicine of the American Academy of Pediatrics and will be appointed chair in November of 2017.


Next steps:

  • At the National Rx Drug Abuse and Heroin Summit in Atlanta, UK clinicians, researchers and health policy leaders led discussions on how to combat the opioid drug crisis.
  • Surgical procedures, both major and minor, require pain management. UK Anesthesiology & Pain Management provides comprehensive anesthesiology services following surgeries, as well as for chronic and cancer-related symptoms.
Researchers and health policy leaders from UK discussed how to combat drug abuse during this year's National Rx Drug Abuse and Heroin Summit.

UK brings expertise to national summit on opioid drug crisis

Addiction researchers, clinicians, intervention coordinators and health policy leaders from UK and UK HealthCare are taking part in a national conversation this week focused on combating the opioid drug crisis.

The National Rx Drug Abuse and Heroin Summit, taking place April 17-20 in Atlanta, is the largest national collaboration of professionals from local, state and federal agencies, business, academia, treatment providers, and allied communities impacted by prescription drug abuse and heroin use. It was introduced in 2012 under the leadership of Operation UNITE and U.S. Rep. Harold “Hal” Rogers (KY-5th) with the purpose of alleviating the burden of illegal substance abuse through comprehensive approaches. In this regard, UK leads the way.

Last year alone, investigators in the UK Center on Drug and Alcohol Research received $9.6 million for projects dedicated to substance abuse and addiction. Since 2010, the National Institute on Drug Abuse has awarded more than $92 million to UK research projects. UK HealthCare is proud to support the summit through sponsorship.

“UK is uniquely positioned to confront these questions because of its multidisciplinary research endeavors, leading academic medical center and regional referral network deployed to confront the scourge of opioids. We’re committed to working in – and with – communities to help navigate the complex nature of critical policy changes and effective healthcare implementation,” UK President Eli Capilouto said.

Kentucky’s rate of opioid overdose death remains above the national average, with the Centers for Disease Control and Prevention reporting 1,273 Kentucky overdose deaths in 2015.

“The opioid epidemic is far-reaching and multifaceted, leaving a void in each family and community it scars,” Capilouto said. “Kentucky families and communities throughout Appalachia know the devastation and havoc of addiction. That’s why this question is critical to UK researchers who lead the research, healthcare and policy questions surrounding opioid abuse.”


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Promising results in UK clinical trial get opioid therapy closer to market

A clinical trial at the UK Center on Drug and Alcohol Research (CDAR) revealed a promising therapy for moderate-to-severe opioid use disorders.

The randomized, double-blind clinical trial compared weekly and monthly dosage of CAM2038, a buprenorphine therapy developed by Braeburn Pharmaceuticals and Camurus, with the current standard of care: a daily dose of buprenorphine/naloxone.

Reaching a milestone for FDA approval

Led by Dr. Michelle Lofwall in UK’s CDAR, the trial established the drug’s non-inferiority to the current treatment, a critical milestone in the application for FDA approval. While results indicated CAM2038 met non-inferiority, a key secondary outcome also demonstrated that CAM2038 was superior to current standard treatment, based on a pre-defined distribution of illicit opioid use.

Opioid overdoses cause more than 30,000 deaths every year, and 2.6 million Americans suffer from an opioid use disorder. More than 12 million people misused a prescription opioid pain reliever and 800,000 used heroin in 2015. The National Institutes on Drug Abuse has called for safe, proven solutions to initiate treatment and stabilize patients through an extended opioid recovery program. The Surgeon General’s Report called for more access to evidence-based effective treatments, like buprenorphine, for opioid use disorders.

The study’s positive results provided the necessary evidence for entering the FDA-approval submission process. Evidence suggests people with a moderate-to-severe opioid use disorder might benefit from receiving an injectable therapy administered on a weekly or monthly basis. The weekly injection is appropriate for induction and initial stabilization, and the monthly injection is better for stabilized patients. Together, both weekly and monthly medications allow for individualized dosing, which is critical for optimal patient outcomes and recovery from a deadly disease.

Eliminating stigmas

Lofwall, a psychiatrist and associate professor in the UK College of Medicine, served as principal investigator on the study, along with Sharon Walsh, director of the CDAR. Lofwall, who sees patients’ personal struggles with opioid use disorder in clinical practice, stresses the need for progressive and practical therapies to treat opioid addiction. An injectable therapy administered in a clinician’s office eliminates the risk of diverting traditional forms of buprenorphine and decreases the risk of relapse and overdose. The discreet nature of the therapy also eliminates any stigma and shame felt by patients taking oral opioid maintenance medications in daily life.

“If approved, the CAM2038 weekly and monthly injectable buprenorphine medications can improve how we treat opioid addiction and decrease the stigma associated with the medication that is in large part due to concerns about non-adherence and diversion,” Lofwall said. “Together with the six-month buprenorphine implant, these new long-acting medication delivery systems would allow us to administer a proven medication to the patients directly, leading to improved medication efficacy as demonstrated in this trial as well as avoiding the potential for missed or stolen doses, diversion or accidental pediatric exposure, which are significant public health concerns.”

Braeburn Pharmaceuticals, an Apple Tree Partners company, is a commercial-stage pharmaceutical company delivering individualized medicine in neuroscience. Long-acting therapeutic treatment options can be essential to improving patient outcomes and facilitating recovery in neurological and psychiatric disorders, which are often complicated by stigma and present significant public health challenges.


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Physical therapy

Physical therapy often better than opioids for long-term pain management

Written by Tony English, PT, PhD, director of the Division of Physical Therapy at the University of Kentucky‘s College of Health Sciences.  

Tony English

Tony English

According to the Centers for Disease Control and Prevention (CDC), sales of prescription opioids have quadrupled in the U.S. since 1999, even though there has not been an overall change in the amount of pain reported.

People with chronic pain conditions unrelated to cancer often depend on prescription opioids to manage their pain. As opioid use has increased, so has the misuse, abuse and overdose of these drugs in Kentucky and across the country.

The statistics are sobering:

  • As many as one in four people who receive prescription opioids long term for non-cancer pain in primary care settings suffer with addiction.
  • Heroin-related overdose deaths more than quadrupled between 2002 and 2014, and people addicted to prescription opioids are 40 times more likely to be addicted to heroin.
  • More than 165,000 people in the United States have died from opioid pain-medication-related overdoses since 1999.
  • Every day, more than 1,000 people are treated in emergency departments for misusing prescription opioids.

The CDC released guidelines in March urging prescribers to reduce the use of opioids in favor of safer alternatives in the treatment of chronic pain. Physical therapy is one of the recommended non-opioid alternatives.

If you or someone you know has pain not related to cancer, consider physical therapy as a safer alternative for managing your pain. Physical therapists diagnose and treat movement disorders that may be contributing to your pain and will develop an active treatment plan specific to your goals.

A 2008 study following 20,000 people over a period of 11 years found that people who exercised regularly reported less pain. Manual therapy can reduce pain and improve mobility so that people have more pain-free movement. That, in turn, promotes more activity, which reduces pain even further. Exercise and manual therapy are two components of an active treatment plan that may be used by a physical therapist to help manage pain.

The American Physical Therapy Association has launched a national campaign called #ChoosePT to raise awareness about the risks of opioids and the choice of physical therapy as a safe alternative for long-term pain management.


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A UK physician created the PATHways clinic to help pregnant women with opioid addiction get clean and learn how to care for their baby.

UK clinic helps pregnant women with opioid addiction

After coming to UK two years ago, Dr. Agatha Critchfield, an OB-GYN at UK HealthCare Women’s Health, was overwhelmed by the cases of pregnant women with opioid addiction she saw in her practice. So she decided to do something about it.

Dr. Critchfield created PATHways, an opioid treatment clinic for pregnant women recovering from addiction. It combines treatment with prenatal care, counseling and a support group. The program is based on the Centering Pregnancy model, which reduces negative outcomes and prepares women to have a child through group counseling and peer support.

PATHways is special because it works to help patients in three important ways. First, the program treats the medical condition of opioid addiction. Then it delivers specialized prenatal care. Finally, PATHways gives women the skills and knowledge to fulfill their maternal roles once their babies arrive.

The program was born out of necessity to serve a large population of prenatal patients coming to UK with substance abuse disorders. Critchfield said few evidence-based opioid treatment programs were designed for pregnant women. So she started one herself, and it has been successfully treating patients who might have otherwise not been helped.

To learn more about the PATHways program and how it has helped many mothers-to-be, click here.