May 16, 2018

Lucemyra Reduces Opioid Withdrawal Symptoms

Lofexidine, the first medication for use in reducing symptoms associated with opioid withdrawal in adults, has been approved by the U.S. Food and Drug Administration. Lofexidine, an oral tablet, is designed to manage the symptoms patients often experience during opioid discontinuation.

Relieves Withdrawal Symptoms

Opioid withdrawal symptoms, which can begin as early as a few hours after the drug was last taken, may include aches and pains, muscle spasms/twitching, stomach cramps, muscular tension, heart pounding, insomnia/problems sleeping, feelings of coldness, runny eyes, yawning, and feeling sick, among others. The product will be marketed under the brand name Lucemyratm.

In 2016, more than 42,000 people died from an opioid overdose, or approximately 115 people per day, according to the National Institute on Drug Abuse (NIDA). Although effective treatments exist for opioid addiction, painful and difficult withdrawal is one of the reasons treatment fails, and relapse occurs.

By alleviating symptoms associated with opioid withdrawal, Lucemyra could help patients complete their discontinuation of opioids and facilitate successful treatment. To date, no other medications have been approved to treat opioid withdrawal symptoms.

Lucemyra Available August 2018

Lucemyra will be marketed by US WorldMeds, a specialty pharmaceutical company that acquired a license for lofexidine from Britannia Pharmaceuticals in 2003. NIDA provided funding to US WorldMeds to support clinical trials to document the clinical pharmacokinetics of lofexidine and to test medical safety and efficacy of the medication, as compared to a placebo, among patients undergoing medically supervised opioid discontinuation.

Lucemyra is expected to be commercially available in the United States in August 2018.

Posted by Webmaster at 08:05 PM

Barriers to Getting Substance Abuse Treatment

For patients with substance use disorders seen in the emergency department or doctor's office, locating and accessing appropriate treatment all too often poses difficult challenges, according to a study in the Journal of Addiction Medicine, the official journal of the American Society of Addiction Medicine (ASAM).

Issues related to patient eligibility, treatment capacity, understanding of options, and communication problems all contribute to gaps in referral and delays to getting treatment for patients with substance use disorders, according to the new research by Claire Evelyn Blevins, PhD, of Warren Alpert Medical School of Brown University and Butler Hospital, Providence, RI; Nishi Rawat, MD, of OpenBeds, Inc., Washington. DC; and Michael Stein, MD, of Boston University and Butler Hospital.

Obstacles to Treatment

The ongoing opioid crisis has drawn attention to the widening gap between the high need and limited access to substance use treatment in the United States. A recent Substance Abuse and Mental Health Services Administration report found that of 21.7 million Americans in need of substance use disorder treatment, only 2.35 million received treatment at a specialty facility. Yet there is little information on the organizational-level barriers to treatment for substance use disorders.

To address this issue, Dr. Blevins and colleagues performed a series of interviews with 59 stakeholders in the treatment referral process. The study gathered input from those who make referrals for substance use treatment, including emergency medicine physicians, addiction specialists, and other medical providers; as well as those who receive referrals, including substance use treatment facility staff and administrators.

Four Broad Themes

Analysis of the interviews identified four broad themes:

Patient Eligibility. Healthcare providers face difficulties in determining whether patients meet criteria for admission to a particular treatment center, including the application of treatment eligibility criteria. "Eligibility requirements may prevent a patient from entering a treatment center," the researchers write.

Treatment Capacity. Even if a patient is eligible, providers have trouble finding out whether space is available. "Despite the need for services, treatment centers may not run at capacity, because of frustrations encountered and time wasted on the referral and admission process."

Knowledge of Treatment Options. Providers may not understand the levels of available care for substance use treatment, and how to select the best treatment for their patient. "After determining appropriate level of care, a provider must then find a program that meets the patient's needs, which becomes more difficult with the differences in terminology and program guidelines."

Communication. Difficulties in communication between referring providers and treatment facilities can contribute to delays to starting treatment. The need for direct referral - "from the emergency department to a bed" - is particularly high for patients with opioid use disorders.

System Needs Improvements

"Access to substance use disorder treatment is often a maze that can be difficult to navigate for both providers and patients," Dr. Blevins and coauthors write. Based on the themes identified, they make recommendations for improvement in the referral process, including a database of clear eligibility criteria, real-time information on treatment capacity, and increased education and training for providers on substance use treatment.

They also propose ways to improve communication and reduce treatment waiting times, including new information technologies. The researchers write: "By improving systems that enhance communication across organizations, patient referrals may be more easily completed, improving access to care and expanding the use of appropriate treatments for the many patients in need."

In an accompanying commentary, David L. Rosenbloom, PhD, of Boston University School of Public Health discusses the underlying reasons for the current "dysfunctional referral system." He notes that referrals for other chronic diseases "may be more effective because they are to 'in-house' affiliated providers." Dr. Rosenbloom writes: "The standard of care should be to stabilize, initiate treatment, and provide a hands-on transfer to an entity that can complete a diagnostic assessment and provide evidence-based treatment" for patients with substance use disorders.

Posted by Webmaster at 08:39 AM

May 04, 2018

Alcohol-Related Cirrhosis More Serious

Alcohol-related cirrhosis patients are sicker, costlier and often female. More than one-third of cirrhosis cases are related to alcohol, a seven-year national study of more than 100 million privately insured people has found.

Among that group, 294,215 people had cirrhosis; 105,871 (36 percent) had alcohol-related cirrhosis. The latter group was sicker and admitted or readmitted to a hospital more often, incurring nearly twice the health care costs per person: $44,835 versus $23,329.

"When I look at this data, it tells me that this is a big problem," says Jessica Mellinger, M.D., a Michigan Medicine gastroenterologist and health services researcher at the Institute for Healthcare Policy & Innovation.

Big Problem for Women

And it could be a particularly big problem for women, who in recent years have been diagnosed with alcohol use disorders at a rate nearly twice that of men.

Mellinger's study, published in the journal Hepatology, found that women showed a 50 percent increase in alcohol-related cirrhosis during that seven-year period; men showed a 30 percent increase.

Although biology doesn't explain why women appear to be consuming more alcohol then they used to, it does shed light on the effects.

"Women process alcohol differently than men and they are more susceptible to damage in the liver than men," says Mellinger. "They can develop cirrhosis with less alcohol and in a shorter time frame. The hypothesis is that certain hormones make women more susceptible, though we don't know exactly why they are so much more susceptible."

A Costly, Widespread Issue

To conduct their study, Mellinger and her team examined privately insured individuals ages 18 to 64 by using the Truven MarketScan Commercial Claims and

Encounters database. It is the largest dataset of claims for people with private insurance obtained through their employers.

The study's goal was to determine the prevalence, health-care utilization and costs of alcohol-related cirrhosis among privately insured people in the United States. The research showed:

Patients with alcohol-related cirrhosis aren't uncommon. The figures nearly surpass those of some common cancers.
Health care for these patients is costly, sometimes as much as the cost for cancer patients.
Cirrhosis has already progressed when many patients see a doctor for symptoms, preventing a chance for early diagnosis and treatment.

Study to Be Expanded

But it only looked at one segment of the population.

"At the time we did this study, we also considered using data sets from Medicare and Medicaid, but they were restricting reporting of claims related to substance abuse, and we knew we'd be missing information," says Mellinger.

Since that time, the Centers for Medicare and Medicaid Services began reporting substance abuse; that information is now open to researchers. Mellinger expects alcohol-related cirrhosis statistics to increase significantly after that patient data is reviewed.

The reason: "Many people with [alcohol-related cirrhosis] are too sick to remain employed, so more of these patients are insured through government-sponsored insurance such as Medicare and Medicaid," she says, noting that another limitation of the study was a lack of information about race and ethnic groups.

Alcohol-Use Treatment Programs Vital

Prior research has shown that there is no ethical justification for deprioritizing patients from receiving a transplant because they have alcohol-related liver disease.

"But first they will need alcohol cessation treatment before they can be transplanted with success," says Mellinger. "Alcohol-use treatment is effective and many patients do stop drinking, obtain transplant and do well afterward."

Although there is stigma to alcohol-related cirrhosis, it is common and it's not a moral failure, she adds. "Many people in the medical community think that alcohol use is not treatable, but it is. There is a lot of collaboration at U-M to provide the right help for patients with alcohol-related liver disease."

Getting that help is crucial: When patients have advanced liver disease, the only action that affects whether they live or die is if they stop drinking.

Cirrhosis Is Permanent

"Once you have cirrhosis, or scar tissue on the liver, it's permanent," says Mellinger, who works closely with the University of Michigan psychiatry department and the University of Michigan Addiction Treatment Services.

"But even though the damage is still there, your liver function can improve dramatically" if you stop drinking.

Set to embark on further study with all insurance payers, Mellinger hopes her current work will help physicians better understand that alcohol-related cirrhosis is a growing problem that demands attention and resources.

"We're only touching the tip of the iceberg," she says. "By demonstrating that alcohol-related cirrhosis is a high-burden health care problem that could be prevented, we hope that it will increase funding for early detection of alcohol use and for greater utilization of alcohol-use treatment programs."

Sources Mellinger JL, et al. "The High Burden of Alcoholic Cirrhosis in Privately Insured Persons in the United States." Hepatology March 2018.

Posted by Webmaster at 08:41 AM