Friday, November 17, 2017

FDA Expands Indication of Electric Stimulation Device to Treat Opioid Withdrawal Symptoms

The Food and Drug Administration (FDA) has approved the use of an electric stimulation device to help to reduce the symptoms of opioid withdrawal, marking the first time a device has been indicated for withdrawal symptoms.

The NSS-2 Bridge is a small device placed behind the patient’s ear that emits electrical pulses to stimulate cranial nerves. These stimulations provide relief from common withdrawal symptoms during the first few days of drug abstinence; these include sweating, tremors, stomach problems, insomnia, and joint pain.

“Given the scope of the epidemic of opioid addiction, we need to find innovative new ways to help those currently addicted live lives of sobriety with the assistance of medically assisted treatment,” said FDA Commissioner Scott Gottlieb, M.D., in a press announcement. “While we continue to pursue better medicines for the treatment of opioid use disorder, we also need to look to devices that can assist in this therapy.”

The FDA marketing approval was granted based on an open-label pilot study of the effects of the nerve stimulator on 73 patients undergoing opioid physical withdrawal. The study found that the average clinical opiate withdrawal scale (COWS) scores of the participants dropped by about 63% after 20 minutes of use, and 85% after 60 minutes. After five days of use, 64 of the 73 participants (88%) successfully transitioned to medication-assisted treatment (MAT). Successful transition to MAT was defined as “those who returned to the clinic and received their first dose of maintenance medication,” the study authors noted in a report published in March in the American Journal of Drug and Alcohol Abuse.

The FDA reviewed the NSS-2 Bridge device through the de novo premarket review pathway, a regulatory pathway that fast-tracks low- to moderate-risk devices that are novel and for which there is no legally marketed predicate device to which the device can be compared. The device was developed by Innovative Health Solutions Inc., and was cleared by the FDA in 2014 for use in acupuncture.

To read more about this topic, see the Psychiatric News article “FDA Clears First Prescription-Based ‘Digital Therapeutic.”

Thursday, November 16, 2017

APA, Five Other Medical Groups Voice Opposition to Senate Proposal to Remove Individual Mandate

Repeal of the mandate under the Affordable Care Act (ACA) to buy health insurance is likely to raise premiums and increase the number of uninsured Americans, APA and five other medical specialty organizations said in a statement released today responding to provisions in the Senate tax reform bill that would eliminate the mandate.

“The Congressional Budget Office (CBO) estimates that repeal of the individual mandate will result in 13 million people becoming uninsured by 2027,” APA and the five other groups said. “Furthermore, repealing the mandate will increase premiums and destabilize the individual and small group markets.”

The five other organizations are the American Academy of Family Physicians, the American Academy of Pediatrics, the American College of Physicians, the American College of Obstetricians and Gynecologists, and the American Osteopathic Association. Together, they represent more than 560,000 physicians and medical students nationwide.

The so-called “individual mandate” requires individuals not otherwise covered by health insurance to buy insurance in the ACA health exchanges or pay a tax penalty. Advocates say that without the mandate to buy health insurance, only the sick would enroll, causing adverse selection and destabilization of insurance markets.

“Our members are the nation’s frontline physicians, providing care to individuals and families in communities large and small, urban and rural,” the groups stated. “They see each day the inherent value of having health care coverage. Health care coverage is the gateway to prevention and wellness and a guardrail in the event of a major health event. Having health care coverage and a continuous relationship with a physician are the two factors that have been proven the world over to increase quality and decrease cost.

“Additionally, increased access to affordable health care coverage is a major reason that bankruptcies related to health care have decreased significantly over the past five years. Health care coverage provides financial security to millions of people and protects them in the most challenging times of their life, especially those that have pre-existing conditions and conditions that require a high intensity of care over their lifetime.

“Our organizations oppose provisions in the Senate tax reform proposal that would repeal policies requiring individuals to purchase health care coverage,” they continued. “Our health care system needs improvements, and our organizations stand ready to work with the Senate to identify bipartisan and impactful reforms that will ensure a robust and competitive health care market. However, according to the Congressional Budget Office, repeal of the individual mandate in this form, absent additional reforms that would stabilize the insurance market, has the potential to raise health insurance premiums by a projected 20 percent and increase the number of uninsured Americans.”

(Image: iStock/Tupungato)

Wednesday, November 15, 2017

Naltrexone, Buprenorphine-Naloxone Found Equally Effective in OUD Patients Who Initiate Treatment

Extended-release naltrexone and sublingual buprenorphine-naloxone appear to be equally safe and effective at preventing opioid relapse in patients with opioid use disorder (OUD). However, it can be harder to initiate patients actively using opioids on naltrexone (due to required detox period) than buprenorphine-naloxone. These two findings were reported in a study published yesterday in The Lancet.

“Both medications are effective treatments for opioid use disorders versus counseling-only approaches or compared to placebo. What is now clear is how similar the outcomes are for those initiating treatment with either medication,” Joshua D. Lee, M.D., M.Sc., of NYU School of Medicine said in a press release. “Patients wanting naltrexone but who are unable to complete detox should be encouraged to start an agonist-based treatment like buprenorphine.”

Naltrexone (an opioid μ-receptor antagonist) differs from buprenorphine both in terms of induction and ongoing care. The medication cannot be initiated until patients are fully detoxified without risking precipitated withdrawal, but once initiated, naltrexone produces no opioid-like effects and no physiological dependence. In contrast, buprenorphine (a partial agonist) can be initiated as soon as patients are in mild-to-moderate withdrawal. Unlike naltrexone, buprenorphine maintains physiological opioid dependence, and withdrawal is likely to occur on discontinuation.

Lee and colleagues randomly assigned 570 patients with OUD to receive monthly injections of extended-release naltrexone (brand name Vivitrol) or daily buprenorphine-naloxone (brand name Suboxone) for 24 weeks. Study participants were 18 years or older and had used non-prescribed opioids in the past 30 days. Unlike patients in the buprenorphine-naloxone group, who received medication shortly after randomization, those assigned to naltrexone had to complete detoxification before receiving the first injection of medication. Detoxification was defined as not using an opioid for three or more days, having urine that tested negative for opioids, and having a negative naloxone challenge.

As expected, fewer patients successfully initiated naltrexone compared with buprenorphine/naloxone (72% versus 94%). Of the 474 patients who successfully began treatment, the proportion of opioid-relapse events over the course of the study was similar (52% for the naltrexone group versus 56% for the buprenorphine/naloxone group). The proportion of participants reporting adverse events and serious adverse events did not differ between the groups, with the exception of reactions at the injection site of naltrexone, all of which were of minor to moderate severity.

“Studies show that people with opioid dependence who follow detoxification with no medication are very likely to return to drug use, yet many treatment programs have been slow to accept medications that have proven to be safe and effective,” Nora D. Volkow, M.D., director of the National Institute on Drug Abuse, said in a press release. “These findings should encourage clinicians to use medication protocols, and these important results come at a time when communities are struggling to link a growing number of patients with the most effective individualized treatment.”

For related information, see the Psychiatric News PsychoPharm article “Psychiatrists Discuss Risks, Benefits of Medications for Opioid Use Disorder.”

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Tuesday, November 14, 2017

FDA Approves Abilify Pill With Embedded Digital Sensor to Track Ingestion

The Food and Drug Administration (FDA) on Monday approved Abilify MyCite—aripiprazole tablets with a sensor that digitally tracks if patients have ingested their medication.

The product is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, and for use as an add-on treatment for depression in adults.

According to an FDA press release, the system works by sending a message from the pill’s sensor to a wearable patch. The patch transmits the information to a mobile application so that patients can track the ingestion of the medication on their smartphone. Patients can also permit their caregivers and physician to access the information through a web-based portal.

“Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, said in the FDA press release. “The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers.”

The FDA noted in its release that the ability of the product to improve patient compliance with their treatment regimen has not been shown. Abilify MyCite should not be used to track drug ingestion in “real-time” or during an emergency because detection may be delayed or may not occur, the agency added.

The “digital health feedback system” (DHFS) has attracted the attention of clinician researchers interested in novel ways to improve medication adherence among patients with schizophrenia and bipolar disorder. In 2010, John Kane, M.D., and colleagues at Zucker Hillside Hospital and Massachusetts General Hospital partnered with Proteus Digital Health Inc.—the manufacturer of the DHFS technology—to characterize the feasibility and safety of the system in patients with bipolar disorder and schizophrenia. A principle concern at the outset was whether patients who may have paranoid or persecutory delusions would be amenable to using a device allowing others to monitor their behavior.

In a paper published in the Journal of Clinical Psychiatry (June 2013), Kane and colleagues found that of the 27 patients with schizophrenia or bipolar disorder who completed the study, none experienced a worsening of psychosis attributable to use of the DHFS, 19 found the DHFS concept easy to understand, and 24 said they believed the technology could be useful to them. (For the purposes of the study, the pill with the embedded DHFS was not pharmacologically active.) 

For related information, see the Psychiatric News article “Technologies Promise to Aid Medication Adherence, but Effectiveness Varies.”

Monday, November 13, 2017

ADHD Medication Use During Pregnancy Poses Modest Birth Risks

The use of attention-deficit/hyperactivity disorder (ADHD) medications during pregnancy can modestly increase the risk of some negative birth outcomes, according to a study published Friday in Pediatrics

Ulrika Nörby, Ph.D., of Lund University in Sweden and colleagues found that infants exposed to ADHD medications during pregnancy were about 50% more likely of being admitted to a neonatal intensive care unit (NICU) than infants whose mothers never took these medications and about 20% more likely to require care in a NICU than infants whose mothers used these medications before or after but not during pregnancy.

Infants exposed to ADHD medications in utero were also more likely to experience central nervous system–related disorders such as seizures (odds ratio=1.9) and were more often born preterm (odds ratio=1.3) compared with infants who were not exposed to these medications. 

“These findings warrant attention but are hardly reasons to abstain from ADHD medication during pregnancy if treatment is crucial for the woman,” Nörby and colleagues wrote. “Because women who used these drugs during pregnancy in many ways differed from the average pregnant population, it is uncertain to what extent these associations can be explained by the ADHD medication itself.” 

Nörby and colleagues analyzed data from Swedish birth and medical registries, including nearly one million single births recorded between July 1, 2006, and December 31, 2014. They identified 1,591 infants (0.2%) who were exposed to ADHD medication during pregnancy (1,464 were exposed to stimulants and 165 were exposed to atomoxetine).

“Despite the authors’ effort to control possible confounding by using a comparison group who carried a diagnosis of ADHD, it is an imperfect control condition,” Kimberly Yonkers, M.D., a professor of psychiatry, epidemiology, and obstetrics, gynecology, and reproductive sciences at Yale University, told Psychiatric News. “Women who used ADHD medication were clearly different in many ways from the other two groups.” 

Yonkers added that the authors did not have information related to the use of illicit substances and alcohol in these women, which could be a contributing factor. She noted that the study found women taking ADHD medications reported much higher levels of nicotine use than those who did not, so it is possible that other substance use by this group was higher as well.

To read more about mental health and pregnancy, see the Psychiatric News PsychoPharm article “Yes or No: Prescribing Antidepressants to Pregnant Patients” by Jennifer L. Payne, M.D., and the American Journal of Psychiatry article “ADHD and Pregnancy” by Marlene P. Freeman, M.D.

(Image: iStock/Halfpoint)

Thursday, November 9, 2017

Antipsychotics May Increase Risk of Aspiration Pneumonia in Older Adults

Antipsychotics are commonly used in hospitals for non-psychiatric purposes, particularly to manage delirium in older hospitalized patients. A study published in the Journal of the American Geriatrics Society found that patients who received antipsychotics for a non-psychiatric purpose had about 40%-50% increased risk of aspiration pneumonia—an infection that occurs following the ingestion of solids or liquids into the lungs—than hospital patients without antipsychotic exposure.

“This association was robust through multiple analytical approaches and persisted when focusing on individuals with discharge diagnoses of delirium and dementia,” wrote lead author Shoshana Herzig, M.D., M.P.H., of Harvard Medical School and colleagues. The researchers also noted there was no association between antipsychotics and nonaspiration pneumonia, which supports the idea of a causal link between antipsychotic exposure and aspiration pneumonia.

Herzig and colleagues analyzed data on patients admitted to a large academic medical center in Boston from January 2007 through July 2013, excluding psychiatric hospitalizations (to focus on off-label antipsychotic use), transfers from other hospitals, or hospitalizations shorter than 48 hours.

Of the 146,552 hospitalizations included in the analysis, antipsychotics were used in 10,377 cases, or about 7%. Aspiration pneumonia occurred in 557 (0.4%) hospitalizations. The incidence of aspiration pneumonia was 1.2% in patients with antipsychotic exposure and 0.3% in unexposed individuals. After adjusting for factors such as patient age, length of hospital stay, and exposure to other medications, the authors found that antipsychotic exposure resulted in a 1.4-1.5 increased odds of aspiration pneumonia; the risks were the same for typical and atypical antipsychotics.

Herzig and colleagues also found that age did not impact the relative risk of aspiration pneumonia, but they pointed out that overall use of antipsychotics steadily increased with age. Exposure rates were 5.2% for patients 65 and under, 7.3% for patients 65-74, and 12.5% for patients 75 and older. As such, the absolute risks of aspiration pneumonia were higher in patients 75 and older.

“[O]ur findings suggest that targeting older adults for interventions aimed at improving antipsychotic prescribing practices will lead to the greatest absolute reduction in the occurrence of this costly and morbid complication,” the authors wrote.

To read more on this topic, see the Psychiatric News article “Mortality Risk High for Dementia Patients Taking Antipsychotics.


Wednesday, November 8, 2017

Guided Online CBT Program May Enhance Collaborative Care for Depression, Anxiety

Incorporating a computerized cognitive-behavioral therapy (CCBT) into a collaborative care program may lead to symptom improvements in patients with depression and anxiety beyond those reported by patients receiving usual care from a primary care physician (PCP), according to a study published today in JAMA Psychiatry

“Our report confirms the effectiveness of guided CCBT, highlights the critical importance of patient engagement with online interventions, and provides high-quality evidence about the limits and potential benefits of these emerging technologies,” wrote Bruce L. Rollman, M.D., M.P.H., of the University of Pittsburgh School of Medicine and colleagues.

The researchers recruited patients aged 18 to 75 years who were recently diagnosed with anxiety, generalized anxiety, panic, or depression from 26 primary care offices in Pittsburgh. Study participants were randomly assigned to one of three interventions for six months: (1) care manager–guided CCBT alone, (2) care manager–guided access to both CCBT and a moderated, password-protected Internet support group (CCBT+ISG), or (3) usual care under their PCP. 

Participants assigned to the CCBT program received an email and phone call from a care manager introducing the eight-session Beating the Blues CCBT program, which included text, audiovisual clips, and “homework” assignments on CBT techniques. Patients in the CCBT+ISG group were also encouraged to participate in moderated discussion boards or check out other resources on the Internet support group page. 

Care managers logged into the CCBT program’s portal to monitor patients’ progress, sent personalized feedback and encouragement via email, and called patients who either had not improved or failed to log in regularly. PCPs were regularly updated about their patients’ progress through electronic medical records. Participants in the usual care group were informed of their anxiety and mood symptoms, and referring PCP, but were not given treatment advice unless suicidality or significant worsening of symptoms was captured during assessments at three, six, and 12 months. 

Over the six-month period, 504 of 603 patients (83.6%) with CCBT access started the program and completed an average of 5.4 sessions. Overall, 228 of 302 patients (75.5%) in the CCBT+ISG arm logged into the Internet support group at least once; of these patients, 141 (61.8%) made at least one online comment or post. 

Patients receiving CCBT+ISG or CCBT alone reported significant improvements in mental health–related quality of life and mood and anxiety symptoms compared with patients receiving usual care at six months—improvements that were still evident when patients were reassessed six months after the intervention ended. The researchers also found that the more CCBT sessions the patients completed, the greater the improvement in their symptoms.    

“[A]lthough our ISG [Internet support group] did not produce any measurable benefit over CCBT alone, providing online CCBT to patients with depression and anxiety receiving primary care via a centralized collaborative care program is an effective strategy for delivering mental health care at scale,” the authors concluded.

For related information, see the Psychiatric News article “Early Follow-Up Is Key to Patient Success in Collaborative Care” and the American Journal of Psychiatry article Improving the Efficiency of Psychotherapy for Depression:Computer-Assisted Versus Standard CBT.”

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