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Simple Blood Test System Detects Brain Injuries

Nerve cells illustration


21 November 2017. An engineering team at Purdue University designed a system that detects indicators of traumatic brain injuries in lab tests with one or two drops of blood. The system is described in a paper published earlier this month in the journal IEEE Sensors Letters (paid subscription required).

Traumatic brain injury occurs when the head is subjected to sudden violent jolt or an object pierces the skull and damages brain tissue. These injuries can range from mild to severe and cause a number of symptoms from headache and dizziness in mild cases to repeated nausea, seizures, slurred speech, and increased confusion in moderate to severe cases.

Mild traumatic brain injuries, known as concussions, occur in some contact sports, such as American football and rugby, requiring quick diagnosis to help determine if participants should stop playing until their conditions improve. The Purdue Neurotrauma Group that took part in this project studies youth sports injuries and found concussions are often the result of an accumulation of blows to the head, not necessarily a single violent hit. And, as a result of these multiple hits, neurological changes occur that release tell-tale proteins into the blood.

The team led by Purdue mechanical engineering professor Jeffrey Rhoads is seeking a simple, inexpensive lab test to detect traumatic brain injury. The researchers designed their system to detect characteristic protein biomarkers of conditions such as traumatic brain injury in minute amounts of blood, as small as one or two drops. This detection of biomarkers could make it possible to spot a disease in its early stages, when more treatment options are available and to prevent deterioration if the disorder is left untreated.

The researchers designed the system to work as a pipette, a common lab device that transports and delivers measured amounts of fluids. Packed inside each pipette dispenser is a sensor, coated with an antibody to detect the target protein. To increase its sensitivity, the sensor vibrates at a high frequency powered by piezoelectric effects from changes in mechanical force or stress. And because a pipette dispenses multiple samples, the system provides a better analytical tool.

“Detecting biomarkers is like trying to find a handful of needles in a large haystack,” says Rhoads in a university statement. “So we devised a method that divided the large haystack into smaller haystacks. Instead of having a single sensor, it makes more sense to have an array of sensors and do statistical-based detection.”

In their study, Rhoads and colleagues tested blood samples for the protein s100 beta found in glial cells that surround neurons in the brain. In cases of traumatic brain injury, s100 beta concentrations increase markedly in cerebrospinal fluid found in the brain and spinal cord. At these high concentrations, S100 beta proteins can leak through the blood-brain barrier, making them detectable in blood samples. The researchers report their system detects S100 beta proteins in small blood samples at a sensitivity high enough to indicate traumatic brain injury.

The Purdue team designed the pipette system as a platform for simple, inexpensive tests to detect a number of conditions beyond traumatic brain injury, and the university applied for a patent on the technology. The Purdue Neurotrauma Group hopes to use the system to screen entire high school football teams for concussions next fall.

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Biotech, Cancer Center Partner on T-Cell Research

Human T-cell lymphocyte

Scanning electron micrograph of a human T-cell lymphocyte (National Institute of Allergy and Infectious Diseases, NIH)

20 November 2017. A developer of cancer diagnostics and treatments is collaborating with Moffitt Cancer Center to advance therapies for ovarian cancer with T-cells from the immune system. The partnership between Moffitt, in Tampa, Florida and ITUS Corp. in San Jose, California is a cooperative research and development agreement, where the parties share staff and facilities, but do not usually involve transfers of funds.

ITUS and Moffitt plan to further develop treatments to attack ovarian cancer tumors. The technology is based on T-cells, white blood cells in the immune system altered to express chimeric antigen receptors, being adopted as treatments for some blood-related cancers, such as leukemia. For these blood-related cancers, the engineered T-cells seek out and bind to a protein called CD19 found on the surface of B cells — another type of white blood cell — associated with several blood-related cancers.

In this project, the chimeric antigen receptor T-cells, or CAR T-cells, are modified to target proteins found on ovarian tumors. While expressed on ovarian tumor cells, these proteins, known as follicle-stimulating hormone receptors, are rarely found on healthy cells. Thus treatments seeking out these proteins are likely to cause fewer adverse effects than many current chemotherapies.

Earlier in November, ITUS licensed this CAR T-cell technology from Wistar Institute in Philadelphia. In January 2017, a team from Wistar Institute led by Jose Conejo-Garcia, published a study testing modified T-cells that target follicle-stimulating hormone receptors in lab cultures and mice grafted with several types of human ovarian cancer. The researchers found the engineered T-cells attacked only the tumor cells across all of the ovarian cancer types in the mice, and not the surrounding healthy tissue.

In addition, mice receiving the altered T-cells showed measurable therapeutic effects, including clearance of the tumors in some cases. Moreover, the modified T-cells persisted in the mice, providing immunity against a later introduction of ovarian tumor cells. And the researchers reported longer survival times among the T-cell recipient mice, without noticeable toxicity.

Under the new agreement, Conejo-Garcia, now at Moffitt Cancer Center, will lead a research team to develop CAR T-cells targeting follicle-stimulating hormone receptors to the point of filing an investigational new drug application, in effect a request to Food and Drug Administration to begin clinical trials. “Successive to the FDA’s review and permission,” says Amit Kumar, president of ITUS in a company statement, “we hope to take this therapy into human clinical testing for patients suffering from ovarian cancer.”

ITUS’s main business is liquid biopsy blood tests called Cchek that detect solid tumor cancers based on immunological responses to malignancy. With licensing of the CAR T-cell technology from Wistar Institute, ITUS formed a subsidiary known as Certainty Therapeutics to develop CAR T-cell treatments for solid tumors, beginning with ovarian cancer. Wistar Institute is also a minority partner in Certainty Therapeutics.

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Bayer Acquiring Therapeutic Peptides in $1.1B+ Deal

Lab flasks

(Republica, Pixabay)

20 November 2017. Bayer AG, the global drug maker and agricultural chemical company, is partnering with a Japanese biologics enterprise to discover a series of peptides for therapies. The deal could bring PeptiDream Inc. in Kawasaki, Japan more than $1.1 billion if all parts of the agreement are completed.

PeptiDream discovers therapeutic peptides, short chains of amino acids that are somewhat similar chemically to proteins but smaller. The company’s discovered peptides, known as constrained peptides and macrocyclics, are small enough to penetrate cell membranes as well as work on cell-surface targets, and can be configured into oral drugs. But these peptides are also large and robust enough to disrupt interactions among proteins, which can be difficult to address with traditional drug compounds and some biologics.

After initial discovery, PeptiDream can also develop its peptides into candidates for peptide therapies or more conventional small-molecule or low molecular weight drugs that address biologic targets. In addition, the company says it can create peptide-drug conjugates that use the ability of peptides to find specific molecular targets, but also deliver drug compound cargoes to those precise targets, making them safer than conventional drugs in many cases.

In the agreement with Bayer, the two companies are collaborating on discovery of peptide and macrocyclics to address an undisclosed number of targets determined by Bayer, using PeptiDream’s platform. The two companies will also refine the discovered molecules into therapeutic peptide and small molecular drug candidates. The license gives Bayer rights to develop and commercialize all of the identified candidates. Bayer also has an option to negotiate for an extension of the license to add candidates for peptide-drug conjugates, as well as diagnostics, bioimaging, and agricultural applications.

The deal provides PeptiDream with an undisclosed initial payment and research funds. The company is also eligible for payments at the completion of preclinical, clinical, and commercialization milestones equaling $1.11 billion if all are fulfilled. PeptiDream will be eligible as well for royalties on sales of Bayer products from the collaboration.

While the license with Bayer is not an exclusive arrangement, PeptiDream says it’s the most extensive so far. “This is one of the broadest discovery deals PeptiDream has entered into,” notes PeptiDream CEO Patrick Reid in a company statement, “covering peptide therapeutics and small molecule therapeutics, and options to peptide drug conjugates, diagnostic agents, bioimaging agents, and more.”

In the past 7 years, says the company, it crafted deals with 17 pharmaceutical companies, most recently Kleo Pharmaceuticals in July 2017. Five other drug makers also licensed PeptiDream’s entire discovery platform.

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Infographic – America’s Immigration Advantages

Immigration and the American economy

(Trade Vistas/CSIS)

18 November 2017. If you’ve read Science & Enterprise for any length of time, you’ve seen that many of the scientists and entrepreneurs in the U.S. featured on our pages come from someplace else. In addition, our report in July of this year from a meeting of university research executives told about their fears of an immigration crackdown doing real damage to their labs and scientific production.

Our friends at Trade Vistas, a project of the Center for Strategic and International Studies in Washington, D.C., compiled a chart outlining the benefits to the U.S. from immigration, posted as this weekend’s infographic. It begins by noting that more than 1 in 3 workers in the U.S. with a PhD in in science, technology, engineering, or mathematics immigrated to this country. Andrea Durkin, Trade Vista’s editor, tells more about immigration’s economic impact and potential in an essay posted yesterday.

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Process Devised for Continuous Stem Cell Production

Disc used to produce cells

Disc used to continuously produce cells (Newcastle University)

17 November 2017. Researchers in the U.K. developed a process for closed-loop continuous production and collection of large quantities of stem cells for therapies. A team from Newcastle University describes its process in today’s issue of the journal ACS Applied Materials & Interfaces (paid subscription required).

The cell production process is a creation of Newcastle’s Institute of Genetic Medicine where a research focus is tissue engineering for regenerative medicine. A team led by tissue engineering professor Che Connon is seeking more efficient and reliable production processes for human cells, particularly where large numbers of individual cells are needed for treatments. The researchers’ goal is a manufacturing process for individual cells like those used today for producing synthetic proteins and biologic drugs, such as vaccines.

Most cell generation processes today use batch production methods in flasks or other lab dishes. Collections of cells produced through these techniques then need to be broken down with enzymes or chemicals to free-up individual cells. The actual quantity of individual cells is limited by the total surface area of the lab dishes used to produce those cells. The researchers say these limits create a bottleneck in the production of therapeutic cells.

Connon and colleagues instead designed a process that produces individual cells for collection, with materials that keep producing the desired cells from a single generation surface. Their process uses a coating of peptides, short chains of amino acids with amphiphilic properties, like fats suspended in water. These peptide amphiphiles then enable the cells to peel away from the surface, and allow for more cells to grow in their place.

The Newcastle team tested their process with corneal stroma or connective tissue stem cells in the eye. The authors report their process grew individual cells at a steady rate, which self-detached from the culture at a rate of about 1 percent of the total number of cells per hour, with the detached cells then collected. In addition, cells generated through this process retained their original traits and properties. The system maintained this production rate for a month. The authors say the process can also be used to produce similar mesenchymal stem cells that transform into bone, cartilage, and other connective tissues.

“Remarkably,” says Connon in a university statement, “with this continuous production technique even a culture surface the size of a penny can, over a period of time, generate the same number of cells as a much larger-sized flask.” Connon adds, “This concept also represents an important innovation for cell-based therapies, where treatments can require up to a billion cells per patient.  With our new technology, one square meter would produce enough cells to treat 4,000 patients ….”

Connon is also scientific founder and chief scientist at Atelerix Ltd., a spin-off company from Newcastle University. Atelerix is commercializing a process for storing and transporting cells at room temperature, instead of freezing, using natural hydrogels, water-based polymers.

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Thin, Flexible, Lower-Cost Motion Sensors Developed

Joshua DeGraff

Joshua DeGraff holds printed flexible motion sensor. (Florida State University)

17 November 2017. Engineers in the U.S. and France created and tested motion-detecting sensors more flexible and thinner than today’s sensors, and made with a low-cost process. A team from the High-Performance Materials Institute at Florida State University in Tallahassee and Institut National des Sciences Appliquées, or INSA, in Lyon, France describe the sensors in the November issue of the journal Materials & Design (paid subscription required).

The team led by INSA’s Pierre-Jean Cottinet is seeking highly sensitive wearable sensors for rehabilitation, robotics, and internet-of-things applications that need to capture motions, sometimes subtle,  made by people wearing the devices. Many current motion-detecting sensors on the market, however, are produced like semiconductors, which can detect motions, but are stiff and inflexible. Other motion detectors are made with more flexible metals, but they tend to be less sensitive and require more costly manufacturing processes.

To meet these needs, the INSA-Florida State researchers designed a sensor technology they say provides the needed flexibility for integration into wearable fabrics and sensitivity to detect subtle motions, but can also be produced inexpensively. Their solution uses multi-wall carbon nanotubes known as BuckyPaper, made into films only 7 microns — 7 millionths of a meter — thick. The team made the BuckyPaper sensors with a commercially available ink-jet printer, adding in silver ink electrodes during the printing process.

The result say the researchers is a motion-detecting sensor that is more sensitive than metallic devices, yet still more flexible than semiconductors. The team tested a prototype device woven into a fabric glove for testing, with encouraging results.

“We measure sensors by gauge factor,” says Florida State doctoral candidate and first author Joshua DeGraff in a university statement, “which indicates how much resistance value changes as a material is strained or bent. Our gauge factor has been up to eight times higher than commercial sensors and 75 percent higher than many other carbon nanotube sensors.” Gauge factor is calculated as the ratio of per-unit change in resistance to per-unit change in length.

Tests with the prototype may have proved the concept of the new motion detector, but the device still needs to be refined before it’s ready for commercialization. The researchers want to make the sensor even thinner to better integrate into fabrics, with more real-world testing to guarantee the device fits into the many curves and shapes of the human body.

“We’re not quite there yet, but this is an important step,” adds Richard Liang, director of the High Performance Materials Institute. “Consumers want great quality and affordable prices, and this material provides both of those things.”

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Biotech Licenses Mayo Clinic Microbiome Research

Gut microbes illustration

Gut microbes illustration (

16 November 2017. A biotechnology company developing therapies with specialized gut microbes is licensing research from the Mayo Clinic on these microbes’ effects with autoimmune diseases. Financial aspects of the agreement between Mayo Clinic in Rochester, Minnesota and Evelo Biosciences in Cambridge, Massachusetts were not disclosed.

Evelo Biosciences discovers and produces therapies for a range of disorders from what it calls monoclonal microbials, derived from natural occurring microbes in the microbiome, communities of beneficial bacteria in the gut. The company says it uses computational techniques to identify gut microbes that can activate or infiltrate immune system cells for attacking tumor cells and their supporting microenvironment. Evelo says its monoclonal microbials are also able to induce regulatory T-cells in the immune system to block the actions of proteins associated with inflammation.

The technology licensed from Mayo Clinic is based on research by immunologist Veena Taneja and gastroenterologist Joseph Murray on the effects of microbial imbalances in the gut on rheumatoid arthritis, an autoimmune condition. With rheumatoid arthritis, the immune system is tricked into attacking healthy cells, that leads to inflammation of joints — wrists, fingers, feet, and ankles — and surrounding tissue.

In a paper published in November 2016, Taneja, Murray, and colleagues reported the effects of Prevotella histicola, a bacterium native to the human gut considered beneficial to the immune system. The Mayo Clinic team induced human rheumatoid arthritis in lab mice, with the animals randomly assigned to receive P. histicola bacteria as treatment, with others left untreated for comparison.

The results show mice receiving the bacteria experienced less arthritic inflammation and less severe inflammation than the untreated mice. The reduced inflammation was traced to reduced autoimmune activity in the treated mice, including generation of regulatory T-cells that often fail to respond to autoimmune conditions. And while the authors say introduction of P. histicola bacteria generated an immune response, the basic or innate immune system in the treated mice remained unaffected.

The agreement gives Evelo Biosciences a worldwide license to the patent rights for this technology. The company says the Mayo Clinic’s findings support its basic technology, and as a result Evelo expects to produce a treatment candidate for clinical trials in 2018.

Evelo Biosciences is a two year-old company, formed by venture investment company Flagship Ventures. In August 2016, the company signed its first collaboration and licensing agreement with Mayo Clinic for microbiome-based cancer therapies. Mayo Clinic, as well as Taneja and Murray, have financial interests in Evelo.

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Report: Health System Not Ready for Alzheimer’s Therapies

Flow chart

Flow chart with projected numbers for Alzheimer’s disease diagnostics and treatment. (Rand Corporation)

16 November 2017. A new study finds the U.S. health care system does not have the capacity for large-scale screening and treatment of people with early indicators of Alzheimer’s disease. The report, Assessing the Preparedness of the U.S. Health Care System Infrastructure for an Alzheimer’s Treatment, was released yesterday by Rand Corporation, a public policy research institute in Santa Monica, California.

Alzheimer’s disease is a progressive neurodegenerative condition affecting growing numbers of older people worldwide. People with Alzheimer’s disease often have deposits of abnormal substances in spaces between brain cells, known as amyloid-beta proteins, as well as misfolded tangles of proteins inside brain cells known as tau. Rand Corp. cites data showing some 5.5 million people in the U.S. are now living with Alzheimer’s-related dementia, with that number expected to grow to 11.6 million by 2040.

The Rand study was sponsored by biotechnology company Biogen in Cambridge, Massachusetts. The company has 5 therapy candidates for Alzheimer’s disease in clinical trials, including two treatments in late-stage studies.

The Rand research team led by health policy specialist Jodi Liu sought to estimate new demands for diagnostics and treatments, particularly from people in the early stage of Alzheimer’s disease, as new treatments for the disease are approved by FDA. The authors note that a number of new drugs and biologic therapies are in late stage clinical trials, including synthetic antibodies removing amyloid-beta plaques, similar synthetic antibodies targeting accumulated tau protein tangles, blockers of enzymes that support amyloid-beta accumulations, and vaccines harnessing the immune system to stop further amyloid-beta and tau deposits.

Liu and colleagues constructed a simulation model to calculate demands put on health care providers if treatments for Alzheimer’s disease became available. The team cites evidence that many people are not screened for Alzheimer’s, even in early stages known as mild cognitive impairment, due to the lack of reliable treatments. If the late-stage clinical trials show positive results and new drugs or biologics become available, more individuals will likely agree to be screened and treated for Alzheimer’s disease if needed.

The Rand model assumes initial screening would take place in primary care settings, doctors’ offices or clinics, for signs of mild cognitive impairment. If those first tests are positive, patients would visit a neurologist or gerontologist for tests of amyloid-beta biomarkers in the brain, as shown in positron emission tomography, or PET, scans. A positive PET scan would then lead to a confirming scan, followed by treatments of drugs by intravenous infusion every 4 weeks for a year.

Results from the model indicate the U.S. health care system does not yet have the capacity to diagnose and treat the 15 million individuals with mild cognitive impairment likely to request these services. The biggest bottleneck is the lack of specialists, neurologists and gerontologists, to diagnose the presence of amyloid-beta plaques. However, lack of PET imaging equipment and infusion facilities for treatments would contribute to the backlogs. See the chart at the top for expected numbers of patients.

The researchers estimate that with the anticipated growth in case loads, patients in 2020 would wait nearly 19 months on average for treatment. Between 2020 and 2040, say the authors, some 2.1 million more people would develop Alzheimer’s while waiting for treatment. The team says that adding additional capacity would require a coordinated effort across the health care industry, at both the national and local levels, including changes in regulatory requirements and reimbursement (e.g., insurance, Medicare) practices.

“While significant effort is being put into developing treatments to slow or block the progression of Alzheimer’s dementia,” says Liu in a Rand Corp. statement, “little work has been done to get the medical system ready for such an advancement. While there is no certainty an Alzheimer’s therapy will be approved soon, our work suggests that health care leaders should begin thinking about how to respond to such a breakthrough.”

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Trial Underway Testing Personal RNA Cancer Drug

Cancer in headline


15 November 2017. A clinical trial is underway testing a treatment for solid tumor cancers derived from messenger RNA, genetic material with protein coding instructions for cells. The trial is conducted by biotechnology company Moderna Therapeutics in Cambridge, Massachusetts, testing the safety of its experimental drug code-named mRNA-4157 both by itself and with the immunotherapy drug pembrolizumab, marketed by drug maker Merck as Keytruda.

Moderna develops therapeutic proteins with a technology that synthesizes messenger RNA, a nucleic acid with the genetic code from DNA used by cells to produce the amino acids in proteins for cellular functions. Moderna manipulates the coding region in the messenger RNA chemistry to provide instructions for cells to produce proteins with specific therapeutic properties. Those coding instructions are contained in a standard package that appears in most cases like natural RNA to avoid triggering an immune response, and reach the desired cells where the therapeutic protein is needed.

Moderna’s mRNA-4157 is an exception to its general technology platform, in that it’s designed to provoke an immune response. In this case, the immune response attacks targets called neoantigens, unique sets of mutations expressed in cancer patients’ tumors. Thus mRNA-4157 is expected to act like a vaccine to induce immune responses specifically targeted to those unique mutations, addressing 20 specific regions on the neoantigen targets.

In June 2016, as reported in Science & Enterprise, Moderna began a collaboration with drug maker Merck to develop a messenger RNA drug to enhance the capabilities of Keytruda that harnesses the immune system to fight tumors. Keytruda is in a class of drugs called checkpoint inhibitors that limit the actions of tumor cells to block the immune system. In this case, Keytruda stops receptor proteins on the surface of tumor cells from blocking the activation of T-cells in the immune system to attack tumors. Keytruda is already approved by Food and Drug Administration to treat a number of solid tumor and blood-related cancers.

The clinical trial is mainly testing the safety of mRNA-4157 for 21 days, but also looking for any evidence of anti-tumor activity over 50 days. The early-stage study is enrolling 90 individuals at 6 sites in the U.S. with a variety of solid-tumor cancers, such as lung cancer and melanoma, that cannot be removed by surgery. Participants will be assigned to receive mRNA-4157 at various dosage levels, to find the maximum tolerated dose, both alone and when combined with Keytruda, as well as among patients with different types of tumors.

The research team is also tracking the ability of mRNA-4157, either with or without Keytruda, to generate antigen-specific T-cells, as well as gauge any effects on biomarkers specific to the tumors in patients. The study is likewise measuring among Keytruda recipients the concentration of the drug in their blood, as well as any antibodies countering the effects of Keytruda. In addition, researchers are tracking response rates to the drugs in the patients’ tumors, as well as overall and progression-free survival time.

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Two Opioid Addiction Treatments Found Safe, Effective

Heroin powder

Heroin powder (Drug Enforcement Administration)

15 November 2017. A clinical trial testing two leading therapies for opioid abuse found the treatments both safe and effective, even though they work in different ways. Results of the comparative effectiveness study, led by researchers at New York University medical school appear in yesterday’s issue of the journal The Lancet (paid subscription required).

The team led by psychiatry professor John Rotrosen and population health specialist Joshua Lee, the paper’s senior and first authors respectively, sought evidence to support choosing between two of the leading drugs prescribed in opioid treatment programs, extended-release naltrexone or a combination of buprenorphine and naloxone. Extended-release naltrexone, marketed as Vivitrol by Alkermes Inc. is given as a monthly injection, while the buprenorphine-naloxone combination, marketed as Suboxone by Indivior Inc. is taken by patients daily as a film dissolved under the tongue.

The drugs work in quite different ways. Vivitrol, the extended-release naltrexone, blocks the activation of opioid receptors and requires complete detoxification before beginning treatment. Suboxone, the combination of buprenorphine and naloxone, still activates opioid receptors, but only mildly, which helps reduce cravings and withdrawal symptoms. The need for complete removal of opioids from the body limits the use of Vivitrol for many prospective patients, while Suboxone can be used as a maintenance drug in a structured treatment program. The two drugs had not been previously evaluated head-to-head.

The clinical trial, funded in part by National Institute on Drug Abuse at National Institutes of Health, enrolled 570 adults addicted to heroin or prescription opioid drugs, and still taking non-prescribed opioids. Participants were recruited from 8 residential treatment facilities in the U.S., where they were randomly assigned to receive either Vivitrol or Suboxone as part of their therapies. The treatments continued for 24 weeks, including outpatient follow-ups after the residential programs.

Rotrosen, Lee, and colleagues looked primarily at relapse-free survival during the 24 weeks, with relapse defined as any non-prescribed opioid use, detected in urine tests and reports from participants themselves. The results show, as expected, a larger percentage of recruits for the study receiving Suboxone (94%) were able to participate in the full treatment programs than those receiving Vivitrol (72%), who first needed to completely detox. As a result, somewhat more of the total participants successfully began their treatment programs with Suboxone (65%) than Vivitrol (57%).

Among participants successfully starting their programs, however, the early relapse percentages are about the same for the two treatments — 52 percent for Vivitrol and 56 percent for Suboxone — both in their urine samples and number of days remaining clean. Self-reported opioid craving was at first lower among Vivitrol recipients, but by the end of the study became similar for both treatment groups. Some Vivitrol recipients experienced mild to moderate injection site reactions, but the number of treatment-related adverse events were otherwise about the same for both groups. Those adverse events include overdoses, including 5 fatal overdoses during the study.

The researchers conclude the two drugs provide different strategies for treating opioid abuse, but once initiated are both safe and equally effective. “The good news is we filled the evidentiary void,” says Rotrosen in a NIDA statement, “and also learned that for those who were able to initiate treatment, the outcomes were essentially identical, as were adverse events. This gives patients the freedom to choose a treatment approach that best suits their lifestyle, goals and wishes.”

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