Search This Blog

Thursday, April 11, 2019

Janssen Presents New Data from 1st Phase 3 of Single-Tablet HIV Regimen

The Janssen Pharmaceutical Companies of Johnson & Johnson unveiled new 48-week data for SYMTUZA® (darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg D/C/F/TAF) showing that a high proportion of HIV patients achieved an undetectable viral load through 48 weeks after rapidly starting SYMTUZA®. A secondary endpoint of the study also showed that 97% of patients reported they were satisfied with their treatment.The results from the DIAMOND study – the first prospective Phase 3 trial studying the rapid initiation of a single-tablet regimen (STR) – were presented at the 13th Annual American Conference for the Treatment of HIV (ACTHIV 2019) in Miami, Florida.
The DIAMOND study evaluated the once-daily STR SYMTUZA® for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult patients who were enrolled within 14 days of receiving an HIV diagnosis and then started on SYMTUZA® before laboratory or baseline resistance test results were available.1 SYMTUZA® is approved by the U.S. Food & Drug Administration (FDA) for the treatment of HIV-1 infection in treatment-naïve and certain virologically suppressed adults.
“Rapid initiation of antiretroviral treatment is becoming the recognized standard of care for newly diagnosed HIV-1 patients, as it has the potential to improve treatment outcomes, including the probability of a person adhering to treatment and staying in care, and could be an additional strategy in our quest to achieve the 90/90/90 prevention and treatment goals as outlined by UNAIDS,” said Moti Ramgopal, M.D., Infectious Disease Director, Midway Immunology and Research Center, Fort Pierce, Florida.* “The DIAMOND study is the first evidence-based STR-specific trial in a rapid initiation model of care. SYMTUZA® was well-tolerated, and a high proportion of patients achieved undetectable viral loads of less than 50 c/mL after 48 weeks.”
DIAMOND is a Phase 3, single-arm, open-label, prospective, multicenter 48-week study evaluating the efficacy and safety of rapidly initiating SYMTUZA®.1 These 48-week data, which follow on from the interim 24-week results presented at the 2018 International AIDS Conference (AIDS 2018), confirm the safety, efficacy and tolerability profile of rapidly starting SYMTUZA® as a treatment for antiretroviral treatment (ART)-naïve adults with HIV-1.
Through 48 weeks, almost 90% (97/109) of patients enrolled in DIAMOND completed the study.1In the primary intent-to-treat (ITT) analysis, 84% (92/109) of patients achieved undetectable viral loads (viral load <50 c/mL; FDA-snapshot), and 8% (9/109) of patients had virologic failure (viral load ≥50 c/mL; FDA-snapshot) at 48 weeks.

Workforce Drug Testing Positivity Climbs to Highest Rate Since 2004: Quest

The rate of workforce drug positivity hit a fourteen-year high in 2018, according to a new analysis released today by Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services. Positivity rates in the combined U.S. workforce increased nearly five percent in urine drug tests (4.2% in 2017 versus 4.4% in 2018), climbing to the highest level since 2004 (4.5%) and are now more than 25 percent higher than the thirty-year low of 3.5 percent recorded between 2010 and 2012.
2019 Quest Diagnostics Drug Testing Index™: Based on the analysis of nearly 9 million workforce urine drug tests performed between January and December 2018.
The new findings of the Quest Diagnostics Drug Testing Index™ were unveiled today at the Drug and Alcohol Testing Industry Association (DATIA) annual conference in Chicago.
For an interactive map with positivity rates and trend lines by three-digit zip code in the United States, visit DTIDrugMap.com.
“Our in-depth analysis shows that marijuana is not only present in our workforce, but use continues to increase,” said Barry Sample, PhD, senior director, science and technology, Quest Diagnostics. “As marijuana policy changes, and employers consider strategies to protect their employees, customers and general public, employers should weigh the risks that drug use, including marijuana, poses to their business.”
Barry Sample, PhD, senior director of science & technology at Quest Diagnostics, and Kimberly Samano, PhD, scientific director at Quest Diagnostics will share the latest data and analysis from the Drug Testing Index via a live webcast on Tuesday, April 16, 2019 at 11 a.m. EDTClick here to register and attend.
Marijuana dominates in general U.S. workforce; opiate positivity declines
Marijuana continues to top the list of the most commonly detected illicit substances across all workforce categories (general U.S. workforce; federally mandated, safety-sensitive workforce; and combined U.S. workforce, which includes the prior two populations) and specimen types (urine, oral fluid, and hair).
The rate of marijuana positivity increased in nearly all workforce categories. In the general U.S. workforce, marijuana positivity increased nearly eight percent in urine testing (2.6% in 2017 versus 2.8% in 2018) and almost 17 percent since 2014 (2.4%).For the federally mandated, safety-sensitive workforce, which utilizes only urine testing, marijuana positivity grew nearly five percent between 2017 (0.84%) and 2018 (0.88%) and nearly 24 percent since 2014 (0.71%).
In the general U.S. workforce, the positivity rate for opiates in urine drug testing declined across all opiate categories. Among the general workforce screening for opiates (mostly codeine and morphine), positivity declined nearly 21 percent between 2017 and 2018 (0.39% versus 0.31%), the largest drop in three years and nearly 37 percent decrease since the peak in 2015 (0.49%). Among the more specific tests for other prescription opiates, the positivity for the semi-synthetic opiates (hydrocodone and/or hydromorphone) declined two percent between 2017 and 2018 (0.51% vs. 0.50%) and 43 percent since the five-year high in 2014 (0.88%). Similarly, the positivity for oxycodones (oxycodone and/or oxymorphone) declined more than 29 percent between 2017 and 2018 (0.61% vs. 0.43%) and more than 46 percent since the five-year high in 2014 (0.80%).
Positivity rates for both heroin and cocaine declined in general and federally mandated safety-sensitive U.S. workforce testing
Urine drug test results for the general U.S. workforce for heroin, indicated by the presence of the 6-acetylmorphine (6-AM) metabolite, declined six percent (0.033% in 2017 versus 0.031% in 2018) and more than 16 percent since its peak in 2015 and 2016 (0.037%). Cocaine positivity declined nearly seven percent in urine and more than 19 percent in oral fluid testing, but increased slightly year-over-year (6.3%) in hair testing.
Both heroin and cocaine positivity in the federally mandated, safety-sensitive workforce showed large declines between 2017 and 2018. Heroin positivity declined nearly 32 percent between 2017 and 2018 (0.019% versus 0.013%), with a decrease of more than 43 percent since 2015 (0.023%). 2018 positivity for cocaine declined nearly ten percent compared with 2017 (0.31% versus 0.28%), when the positivity rate was the highest in more than five years.
New Federal rules for opioid testing drive increase in safety-sensitive workforce positivity
Changes to Federal rules for drug testing the federally mandated, safety-sensitive workforce went into effect in January 2018. The addition of four semi-synthetic opiates contributed to the large increases in year-over-year positivity among those workers. In 2018, testing for semi-synthetic opiates (hydrocodone and/or hydromorphone) and for oxycodones (oxycodone and/or oxymorphone), the positivity rate was 0.45 percent and 0.34 percent, respectively. These positivity rates are both slightly less than general U.S. workforce testing.
Increases in post-accident positivity occur in both the federally mandated, safety-sensitive and, general U.S. workforce
In the federally mandated, safety-sensitive workforce, positivity for post-accident urine testing jumped more than 51 percent year-over-year (3.1% in 2017 versus 4.7% in 2018) and increased by nearly 81 percent between 2014 and 2018. The jump in 2018 was largely driven by the addition of prescription opiates to the panel where the post-accident positivity for the semi-synthetic opiates (hydrocodone and/or hydromorphone) and for oxycodones (oxycodone and/or oxymorphone) was 1.1 percent and 0.77 percent, respectively. Post-accident positivity in the general U.S. workforce climbed nine percent year-over-year (7.7% in 2017 versus 8.4% in 2018), and 29 percent over five years. The post-accident positivity rate has risen annually since 2011 in the general U.S. workforce and since 2010 in the federally mandated, safety-sensitive workforce.
“Increases in post-accident positivity among safety-sensitive workers should serve as a warning to employers that employee drug use may increase the risk of workforce accidents or injuries,” said Kimberly Samano, PhD, scientific director, Quest Diagnostics. “Our analysis suggests that employers committed to creating a safe, drug-free work environment should incorporate strategies that monitor drug use above and beyond pre-employment drug screening.”
Rise in urine specimens reported as invalid suggests more efforts to “cheat the test”
Findings show an increased percentage of urine specimens in both the federally mandated, safety-sensitive and general U.S. workforces reported as invalid due to inconsistency with normal human urine, suggesting attempts at specimen adulteration or substitution. Between 2017 and 2018, the percentage of invalid results in the federally mandated, safety-sensitive workforce jumped 80 percent (0.15% versus 0.27%), and 40 percent in the general U.S. workforce (0.15% versus 0.21%).
About the Quest Diagnostics Drug Testing Index™
The Quest Diagnostics Drug Testing Index™ (DTI) is a series of reports that provide insights into trends in workforce drug use, based on positivity results for de-identified laboratory testing performed by Quest Diagnostics for a range of illicit, legal and prescription drugs. It examines test results according to three categories of workers: federally mandated, safety-sensitive workers; the general workforce; and the combined U.S. workforce. Federally mandated, safety-sensitive workers include pilots, bus and truck drivers, and workers in nuclear power plants, for whom routine drug testing is mandated by the U.S. Department of Health and Human Services. Quest Diagnostics has analyzed annual workplace drug testing data since 1988.
The strengths of the DTI analysis include its large, nationally representative sample size, longitudinal monitoring, a testing population that is generally reflective of the U.S. workforce and the quality of the company’s drug testing services to confirm positive results. Limitations include analysis only of employers that perform drug testing with the company, and a lack of exact cross-specimen comparisons due to variations in substances for which employers test. Quest Diagnostics has analyzed annual workplace drug testing data since 1988 and publishes the findings as a public service.

Minerva presents roluperidone data to address symptoms of Schizophrenia

Minerva announced the presentation of a poster at the Congress of the Schizophrenia International Research Society. Findings to be presented in the poster demonstrate that administration of roluperidone increased BDNF release by astrocytes and hippocampal neurons obtained from the cerebral cortex of newborn rats, as well as the release of GDNF in cultured astrocytes. Furthermore, data showed that roluperidone enhanced BDNF gene expression at drug concentrations similar to those observed in humans at tested doses. Based on these results, researchers suggested that the effect of roluperidone on BDNF and GDNF may indicate the potential of this investigational compound for disease modification and improved neuroplasticity, in addition to its observed effects on the sigma and serotoninergic 5-HT neurotransmitter pathways.

Fred’s to evaluate strategic alternatives, close 159 stores by end of May

https://thefly.com/landingPageNews.php?id=2891360

Supernus ADHD drug can reach $500M in sales, says Jefferies

Supernus Pharmaceuticals’ SPN-812 has generated promising efficacy and safety data and several features may differentiate it from market leader Straterra, Jefferies analyst David Steinberg tells investors in a research note. The analyst estimates sales could reach $500M or more over time post a projected 2020 launch. The overall adult attention-deficit/hyperactivity disorder market remains “very large” and within the category, non-stimulant drugs represent a “major opportunity” and the two FDA approved drugs available are “suboptimal,” Steinberg contends. He keeps a Buy rating on Supernus with a $58 price target.

Passport news in KY removes overhang on Evolent’s stock, says Canaccord

Canaccord analyst Richard Close maintained a Buy rating and $19 price target on Evolent Health after news outlets reported that Passport Health Plan said Medicaid rates in Kentucky were finalized this week, implying a blended positive rate increase of 4.7% for PHP. Close tells investors in a research note that the “positive” news removes a recent overhang on Evolent’s stock and gives him greater confidence in the company’s ability to achieve 2019 guidance. He would be an aggressive buyer of the stock.

Citi sees $105 as ‘realistic’ takeout price for Esperion after approval

Citi analyst Joel Beatty believes bempedoic acid is likely to be approved and sees potential for Esperion Therapeutics to be acquired post approval in Q1 of 2020. The analyst sees $105 per share as a “realistic” takeout price after a U.S. approval. He believes an FDA panel in the second half of 2019 is likely and that if Esperion announces a panel will not be needed, it would be positive for the shares. In the event U.S. approval is not granted but approval in Europe is still a success, Beatty sees Esperion shares falling to $25. He has a Buy rating on the stock with a $75 price target.