The FDA has approved cysteamine ophthalmic solution 0.37% (Cystadrops, Recordati Rare Diseases, Inc.) for the treatment of patients living with cystinosis. The solution is the first FDA-approved cysteamine eye drop formulation that reduces corneal crystals with dosing 4 times a day, according to Andrea Recordati, CEO of Recordati Rare Diseases.

Cystinosis is a rare genetic condition present from birth. The condition causes the build-up of cystine crystals throughout the body, which causes widespread tissue and organ damage, and significantly impacts the eyes. Patients living with cystinosis often have sensitivity to light, eye discomfort and pain. Recent developments in treatment have led to increased life expectancies of those living with the disease.

In a phase 1/2a open label, controlled, randomized study across multiple centers, 15 patients were given cysteamine ophthalmic solution 0.37%. Eight participants also were part of an adaptive dose-responsive clinical trial. Corneal cystine density was assessed using 

The study found that patients receiving cysteamine ophthalmic solution 0.37% saw a 40% reduction in IVCM scores across all corneal layers 90 days after the baseline. Those in the adaptive dose-response clinical trial saw a 30% decrease in IVCM score, which was maintained through the 5-year study period.

“People living with cystinosis and their caregivers have to manage multiple medications every day. To reduce their daily burden, Recordati worked to develop a new viscous eye drop formulation for treating corneal cystine crystals,” said Recordati, in a prepared statement.

Common adverse effects associated with cysteamine ophthalmic solution was stinging, blurred vision, eye irritation, and eye redness. It is applied 4 times daily as a drop during waking hours and can be stored for up to 7 days at room temperature after opening.

U.S. FDA Approves CYSTADROPS® (Cysteamine Ophthalmic Solution) 0.37%, A New Practical Treatment Option for the Ocular Manifestations of Cystinosis (Press release) White Oak, MD, August 28, 2020 EurekAlert! Accessed August 28, 2020

Articles

Drops of cysteamine ophthalmic solution are applied 4 times a day.

FDA Approves Ophthalmic Solution for Treatment of Cystinosis

A new study from the Yale School of Public Health has found that higher rates of e-cigarette and marijuana use did not result in more e-cigarette or vaping-related lung injuries (EVALI) in the United States.

The study estimated the relationship between states’ total reported EVALI cases per capita as of January 2020, and pre-outbreak rates of adult vaping and marijuana use. The results showed higher rates of vaping and marijuana use are associated with fewer EVALI cases per capita.

“If e-cigarette or marijuana use per se drove this outbreak, areas with more engagement in those behaviors should show a higher EVALI prevalence,” said assistant professor and study author Abigail Friedman in a press release. “This study finds the opposite result. Alongside geographic clusters of high EVALI prevalence states, these findings are more consistent with locally available e-liquids or additives driving the EVALI outbreak than a widely used, nationally-available product.”

The CDC started a cross-state investigation into vaping-related lung injuries in August 2019, which confirmed more than 2800 cases and 68 deaths. In February 2020, the CDC concluded its national updates and officially classified vitamin E acetate, the additive linked to EVALI and common THC e-liquids, as the “primary cause of EVALI.”

Since the EVALI outbreak, a variety of state and federal legislative actions were passed to restrict sales of nicotine e-cigarettes, including a temporary ban on all e-cigarette sales in Massachusetts in late-2019 and bans on flavored e-cigarette sales in several states and localities, according to the study. The researchers suggest that those policies may have targeted the wrong behavior if the goal was to reduce EVALI risks.

According to Friedman, a negative relationship between EVALI prevalence and rates of pre-outbreak vaping and marijuana use suggests that well-established markets may have crowded-out the use of riskier, informally sourced e-liquids.

The 5 earliest states to legalize recreational marijuana (Alaska, California, Colorado, Oregon, and Washington) all had less than 1 EVALI case per 100,000 residents from 12 to 64 years of age. However, none of the highest EVALI-prevalence states (Utah, North Dakota, Minnesota, Delaware, Indiana) allowed recreational marijuana use.

“If this policy led some recreational marijuana smokers to switch to vaping THC, perhaps in order to avoid detection, it would have increased their likelihood of exposure to contaminated e-liquids when those came on the market. This may have contributed to the higher EVALI prevalence in those states,” said Friedman in a press release.

It may be crucial for policymakers to consider the potential unintended consequences of policies that forbid smokable marijuana while allowing THC e-liquids going forward.




Rates of e-cigarette and marijuana use not associated with larger outbreaks of vaping-related lung injuries, YSPH study finds. Yale School of Public Health. 

https://publichealth.yale.edu/news-article/26879/

. Published August 25, 2020. Accessed August 26, 2020.


The results showed higher rates of vaping and marijuana use are associated with fewer EVALI cases per capita.

Study Finds Rates of E-Cigarettes, Marijuana Use Not Associated With Vaping-Related Lung Injuries

The Department of Defense (DoD) awarded Adaptive Phage Therapeutics (APT) $9.8 million for the development of multiple high-priority, bacteriophage-based display vaccine candidates against coronavirus disease 2019 (COVID-19).

APT is currently the only company investigating a phage-based COVID-19 vaccine program that is set to begin clinical trials in 2020, according to a company press release. The award from the DoD will support APT’s ability to advance and evaluate vaccine candidates in phase 1 clinical trials this year.

Therapeutic use of phage-based vaccines is well-understood and has a favorable safety profile, offering specific advantages as a vaccine candidate option, according to APT. Phage-based vaccines work by establishing a platform approach that provides the opportunity to adjust the vaccine in response to mutations in the coronavirus. Phage-based vaccines are also self-adjuvanted, which means they are capable of automatically activating and boosting immune response, allowing for multiple antigens to be displayed, according to APT.

“A vaccine against COVID-19 will be a critical enabler to protect our service members and the American people,” said Thomas Dunn, acting program manager, Naval Advanced Medical Development, Naval Medical Research Center, in a press release. “This research contract will expedite prospective efforts to deliver a safe and effective phage-vaccine."

Additionally, recent studies have demonstrated that immunity to COVID-19 may be transient and require frequent booster vaccinations in order to maintain immunity. For this reason, APT has been investigating delivery of the vaccine orally in the form of a lozenge that would facilitate necessary booster doses with greater ease.

“We anticipate phase 1 trials to demonstrate safety and immunogenicity,” said Greg Merril, CEO and co-founder, APT, in the press release. “The potential benefits of a phage-based vaccine include versatility for route of administration (mucosal and intramuscular), including a potential oral lozenge, adaptability to virus mutations, speed of development and cost-effectiveness. These benefits, along with the established safety profile of phage, offer hope as a potential tool in mitigating this terrible pandemic.”

Merril noted that the company is also ready to rapidly scale up production in the United States should the vaccine be approved by the FDA.

“We are fully committed to deploying our facilities and our staff to fight the impact of this public health crisis,” Merril said.




Adaptive Phage Therapeutics Receives Department of Defense Award for Development of COVID-19 Vaccine. Gathersburg, MD: Adaptive Phage Therapeutics; August 20, 2020. businesswire.com/news/home/20200820005593/en. Accessed August 21, 2020.

The Department of Defense awarded Adaptive Phage Therapeutics $9.8 million for the development of multiple high-priority, bacteriophage-based display vaccine candidates against COVID-19.

Department of Defense Awards Adaptive Phage Therapeutics $9.8 Million for Development of COVID-19 Vaccine

The coronavirus disease 2019 (COVID-19) pandemic may be having a widespread effect on people’s mental health, according to a new study published in 



The COVID-19 pandemic has caused more than 800,000 deaths worldwide and there has been over 23.4 million confirmed cases, according to the World Health Organization. The pandemic has led to widespread shutdowns and social distancing measures, with schools and businesses closed, and a subsequent spike in unemployment.

The study authors analyzed Google search queries that mentioned “panic attack” or “anxiety attack” from the United States between January 2004 and May 9, 2020. Examples of the queries they used are “am I having a panic attack” and “signs of an anxiety attack.”

The study authors chose to look at anxiety attacks because they are indicative of, or can often lead to, other mental health problems, such as depression. Anxiety attacks are also triggered by outside stressors and are socially contagious. The study authors then evaluated trends after President Donald Trump declared a national emergency on March 13, 2020.

The largest growth in queries occurred between March 16, 2020, and April 14, 2020, with a cumulative increase of 17%, according to the study. This increase coincided with the release of national social distancing guidelines on March 16 and their extension on March 29.

Additionally, the study authors found that searches for anxiety attacks coincided with the United States surpassing certain international benchmarks, such as surpassing China in most reported cases on March 26 and surpassing Italy for most deaths on April 11. An increase was also seen when the Centers for Disease Control and Prevention recommended facemasks on April 3.

"In practical terms, over the first 58 days of the COVID-19 pandemic, there were an estimated 3.4 million total searches related to severe acute anxiety in the United States…In fact, searches for anxiety and panic attacks were the highest they've ever been in over 16 years of historical search data," Benjamin Althouse, PhD, principal scientist at the Institute for Disease Modeling, said in the press release.

The researchers said that it may take years to fully deal with the fallout from the COVID-19 pandemic. As such, resources should be made available to those who need it the most, the study authors concluded.

Reference:

Am I having a panic attack? Internet searches for anxiety attacks take off during COVID-19 (Press Release), La Jolla, CA. August 24, 2020, EurekAlert! Accessed August 25, 2020

Over the course of the COVID-19 pandemic, Google searches for anxiety have climbed 17%. 

Study: COVID-19 Pandemic Causing Mental Health Issues

Coping with peanut allergies is largely driven by fear of accidental exposure and allergic reaction, according to a study from Aimmune Therapeutics. The investigators found that his fear and stress can have major emotional and social effects for children and teens with peanut allergies as well as their caregivers.

According to Aimmune, the APPEAL-2 study was designed to explore several ways that peanut allergies impact youth and caregivers. Patients with these allergies frequently experience frustration, stress, uncertainty, and low levels of confidence in managing their allergy, according to the study’s results.

“In their own words, children, teens, and their caregivers revealed the day-to-day difficulties of living with peanut allergy, and how the lack of societal awareness impacts their emotional and social development,” said investigator Audrey Dunn Galvin, PhD, in a statement.

The investigators found that most teenagers reported negative experiences when going to restaurants, including embarrassment at having to declare their allergy or being treated unkindly by staff. A quarter of teens also reported that their allergy impacted dating and romantic relationships.

Nearly a third of children and a small number of teenagers said they did not want others to know about their allergy and actively chose not to disclose it. Some said this was because of embarrassment, while others said it was to avoid teasing or bullying. Nearly all children and teens reported a negative impact on their social activities, adding that they avoided social situations as a strategy of disease management. They also felt left out or envious because they feel unable to attend social events, and several participants reported incidents of teasing or bullying.

The researchers also found significant impacts on caregivers, who reported many of the same emotional impacts. Over a third reported that their child’s allergy had a negative impact on their work or career, including having to take time off and limiting their working hours. The authors emphasized that this could illustrate a potential socioeconomic impact for families with peanut allergies.

Caregivers also reported that buying and preparing food was a major, time-consuming aspect of managing their child’s allergy, and often mentioned the need to determine suitable places to eat and the nearest hospital or pharmacy before going out. Nearly a quarter of respondents said they prefer to avoid social events if peanuts were served or if they would have no control over the environment, and some caregivers did not allow their children to attend social events.

The authors noted that this caregiver anxiety is rooted in a lack of control. Approximately half of caregivers reported that they worry about having less control over their child’s food and environment as the child ages and becomes increasingly independent.

Although these findings reveal frustration and fear for children with peanut allergies and their parents, the researchers also noted several opportunities to reduce the burden of living and coping with such allergies. Education is vital in order to increase awareness and understanding, among both the general public and health care professionals. They also recommended adding clearer and more meaningful precautionary allergen food labeling, as well as developing more informative communication around food allergen risks and safety.

Largest European Qualitative Study on Peanut Allergy Highlights Negative Impact of Avoidance and Fear of Accidental Peanut Allergy Reactions on Allergic Individuals and Their Caregivers [news release]. Aimmune Therapeutics; August 24, 2020. 

https://ir.aimmune.com/news-releases/news-release-details/largest-european-qualitative-study-peanut-allergy-highlights

Many caregivers reported that their child’s peanut allergy negatively impacts their job or career, suggesting potential socioeconomic impacts on families.

Peanut Allergy Study Emphasizes Impact of Avoidance, Fear of Accidental Reaction

A new study from researchers at the University of Turku, Abo Akademi University, and University of Bristol, found that people who tend to react negatively to rules and recommendations have lower trust in medical doctors and a more negative attitude toward vaccines, which may cause them to reject vaccines for themselves or their children.

The defiance in people acting negatively toward vaccines may stem from the vaccine recommendations given by authorities or social pressure in society to get vaccinated, according to the study.

The study authors also found that defiance and lower trust in physicians correlated to a higher likelihood to use complementary and alternative medicine (CAM), or treatments and substances that are not included in evidence-based medicine. These treatments have not been clearly demonstrated through established scientific methods.

A list of CAM products was presented to 770 parents of young children, from which they were asked to select the products they had using during the past 12 months to treat an illness or to maintain good health. Further, approximately 40% of the parents reported using 1 or more CAM products.

The results showed that half of the parents reported taking the flu vaccine during the preceding season. Although approximately 75% of the parents had accepted the childhood vaccines for their children without hesitation, approximately 7% had refused to take a vaccine for their child at least once.

However, 9 out of 10 parents partly or completely trusted the physician’s ability to make correct diagnoses and that physicians have their patients’ best interest in mind when making health-related decisions, according to the study.




Defiance and low trust in medical doctors related to vaccine skepticism. University of Turku. 

https://www.utu.fi/en/news/press-release/defiance-and-low-trust-in-medical-doctors-related-to-vaccine-scepticism

. Published August 20, 2020. Accessed August 25, 2020.

Negative feelings toward vaccines may be caused by the recommendations given by authorities or social pressure in society to get vaccinated, according to a study.

Study: Defiance, Low Trust in Medical Doctors Related to Vaccine Skepticism

Walgreens is now offering flu shots daily at all of its nearly 9100 pharmacies, with additional safety measures in place that follow the CDC’s recommendations for anyone over 6 months of age to get the flu shot.

“The convergence of COVID-19 and flu season means that flu vaccinations are critical to reduce the overall burden of respiratory illnesses on the healthcare system and help protect communities,” said Kevin Ban, MD, chief medical officer of Walgreens, in a press release. “Getting your flu shot at Walgreens is one more thing we know everyone can do to help keep themselves and their loved ones healthy, in addition to social distancing, thorough hand washing and wearing face coverings.”

Back in June, Walgreens announced their implementation of additional safety measures or exceeding CDC guidelines for pharmacy team members and patients to best meet anticipated demand for flu shots this season.

Some of the new preparations for customers include filling out any paperwork online, bringing a face covering to enter the Walgreens store, and bringing insurance information and photo identification.

Further, enhanced cleaning regimens, plexiglass shields, and social distancing protocols will be maintained at all Walgreens locations. All pharmacy team members who administer the flu shot will be wearing plastic face shields as additional protection in addition to their disposable face masks and gloves. Before administering the immunizations, pharmacy team members will take patients’ temperature and screen for the presence of symptoms or illness.




Flu shots now available at all Walgreens pharmacies. Walgreens. 

https://news.walgreens.com/press-releases/general-news/flu-shots-now-available-at-all-walgreens-pharmacies.htm

. Published August 17, 2020. Accessed August 18, 2020.


Walgreens is now offering flu shots daily at all of its nearly 9100 pharmacies, with additional safety measures in place that follow the CDC’s recommendations for anyone over 6 months of age to get the flu shot.


Flu Shots Now Available at All Walgreens Pharmacies

To support pediatricians, pharmacists and primary care physicians as schools reopen during the pandemic, MJH Life Sciences™ today announced it will host “Debating the Road Back to School,” a free, live, one-hour webinar on Thursday, Aug. 20, at 6 p.m. EDT.

August traditionally kicks off back-to-school time in the United States, but this year presents challenges as the number of new, confirmed coronavirus cases increases each day in many parts of the country. As a result, school administrators, nurses and teachers are trying to reopen while protecting student safety and preventing new infections.

This panel discussion will feature some of the biggest names in the pediatric and pharmacy fields, who will discuss Centers for Disease Control and Prevention guidelines, how to return to school safely and how to counsel parents through this confusing time. They’ll also address the pros and cons of adding the new coronavirus to the list of state-mandated immunizations for children once a vaccine is available.

The moderator will be Kathleen Kenny, Pharm.D., the president and CEO of Med Ink Exec, and panelists include Donna Hallas, Ph.D., PPCNP-BC, CPNP, PMHS, FAANP, FAAN, a clinical professor and the director of the pediatric nurse practitioner program at NYU Rory Meyers College of Nursing, and Paul Lipkin, M.D., an associate professor of pediatrics at Kennedy Krieger Institute and Johns Hopkins University School of Medicine.

“From the start of the COVID-19 lockdown, we recognized how important it was for our audiences to receive impartial, up-to-the-minute, science-based information and education about the crisis,” said Mike Hennessy Jr., president, and CEO of MJH Life Sciences™. “That’s why we began immediately creating detailed, COVID-specific content and webinars relevant to all medical specialties (for example, our ‘

Multisystem Inflammatory Syndrome in Children: A new wrinkle in COVID-19’ webinar

), including fielding research into pandemic has affected physician’s practices today and into the future the most recent success of the widely attended and highly rated “

” webinar, we decided to host another educational and time-sensitive webinar to support these clinicians on the front lines.”

During the webinar, the panelists will provide insight on the following pressing questions:


Can children return to school and be in classroom environments that ensure health and well-being for all?

What factors must be considered when creating reopening policies, in terms of masks, testing and infection-prevention methods?

Where do children fall on the list of recipients once a vaccine is made available, and will that immunization be mandated?


MJH Life Sciences™ is the largest privately held, independent, full-service medical media company in North America dedicated to delivering trusted health care news across multiple channels, providing health care professionals with the information and resources they need to optimize patient outcomes. MJH Life Sciences™ combines the reach and influence of its powerful portfolio of digital and print product lines, live events, educational programs and market research with the customization capabilities of a boutique firm. Clients include world-leading pharmaceutical, medical device, diagnostic and biotech companies. For more information, please visit https://www.mjhlifesciences.com/.

To support pediatricians, pharmacists and primary care physicians as schools reopen during the pandemic, MJH Life Sciences™ today announced it will host “Debating the Road Back to School,” a free, live, one-hour webinar on Thursday, Aug. 20, at 6 p.m. EDT.

MJH Life Sciences™ Hosts Expert-Driven 'Debating the Road Back to School' Live Webinar

Today, the Department of Health and Human Services (HHS) and Department of Defense (DoD) announced a deal with Moderna, Inc, to manufacture and deliver 100 million doses of the manufacturer’s 

.

Moderna will manufacture these vaccine doses, which will be owned by the US government, as clinical trials are conducted simultaneously. In a press release, the DoD and HHS said that manufacturing the vaccine while clinical trials are ongoing will expedite the traditional development timeline.

If the vaccine doses are used as part of a COVID-19 vaccination campaign, it would be available to Americans at no cost; however, health care providers may charge for the cost of administering the vaccine, according to the HHS.

This initiative will also bolster the US government’s Operation Warp Speed, which aims to begin delivering safe and effective COVID-19 vaccines to the US population by the end of 2020.

“In creating a vaccine portfolio for Operation Warp Speed, the Trump Administration is increasing the likelihood that the United States will have at least 1 safe, effective vaccine by 2021,” said HHS Secretary Alex Azar, in a press release. “Today’s investment represents the next step in supporting this vaccine candidate all the way from early development by Moderna and the National Institutes of Health, through clinical trials, and now large-scale manufacturing, with the potential to bring hundreds of millions of safe and effective doses to the American people.”

Should the vaccine be approved by the FDA, doses of the vaccine will be distributed and administered as part of a COVID-19 vaccination campaign, according to the press release.

The Biomedical Advanced Research and Development Authority worked in conjunction with the DoD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and Army Contracting Command to provide up to approximately $1.5 billion in funding to produce and deliver the vaccine to government-designated locations across the country, the agencies stated in a press release. Additionally, the US government can acquire up to 400 million additional doses of the vaccine.

The agencies also announced that fill-finish manufacturing will be conducted in US-based facilities, which will ensure the vaccine doses are packaged and ready to ship immediately, subject to successful clinical trials and FDA authorization.

May, Moderna, Inc, announced a collaboration with Lonza Ltd

, to manufacture the mRNA vaccine (mRNA-1273) candidate, for immunization against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), on a larger scale.


Over time, the companies plan to maintain additional production sites at Lonza’s facilities internationally, which should allow for the companies to develop to up to 1 billion doses of mRNA-1273 per year, they announced in a 

The mRNA-1273 vaccine was selected by Moderna in collaboration with investigators from Vaccine Research Center at the National Institute of Allergy and Infectious Diseases, a part of the National Institutes of Health (NIH). The first clinical batch was finished on February 7, 2020, and underwent analytical testing at that time. That first batch was then shipped to NIH on February 24, which was 42 days following the sequence selection.

Moderna submitted an Investigational New Drug application to the FDA for phase 2 and late stage studies of mRNA-1273 on April 27, 2020.

A phase 3 clinical trial that began on July 27 is the first government-funded phase 3 clinical trial for a COVID-19 vaccine in the United States.

This article was originally published by Pharmacy Times. 

Moderna will manufacture doses of its experimental coronavirus disease 2019 vaccine candidate as clinical trials are ongoing to expedite the production process.  

100 Million Doses of Experimental COVID-19 Vaccine to be Produced Under New US-Moderna Deal

Officials with the FDA have approved the opioid olicerdine (Olinvyk, Trevena) for intravenous (IV) use in the hospital setting.

Olicerdine is indicated for patients with severe pain who require an IV opioid when alternative treatments prove to be inadequate, according to the press release. It is only approved for short-term IV use in a controlled clinical setting and is not approved for at-home use.

In a controlled, open label trial, 1535 patients were treated with olicerdine. The patients were living with moderate to acute pain after undergoing a bunion or abdominal surgery. Safety and efficacy were established by comparing the opioid against a randomized placebo.

The recommended daily dose limit of olicerdine is 27 mg. Patients who received olicerdine reported a decrease in pain compared with the placebo. According to the press release, olicerdine has a safety profile that is similar to other opioids.

“Addressing the opioid crisis remains a top priority for the FDA. We will continue to do everything we can to reduce the number of Americans who are addicted to opioids and cut the rate of new addiction through a number of cross-agency initiatives…Importantly, the FDA will only approve new drug applications, including those for opioid medications, following a rigorous review to evaluate the risks and benefits and ultimate determination that the data support safety and effectiveness,” Deputy Director for Regulatory Programs in the FDA’s Center for Drug Evaluation and Research, Douglas Throckmorton, MD, said in the press release.

Common adverse reactions were nausea, vomiting, dizziness, headache, and constipation, which is similar to other opioids. According to the press release, olicerdine should not be administered in an unmonitored setting to patients with significant respiratory depression or severe bronchial asthma.





FDA Approves New Opioid for Intravenous Use in Hospitals, Other Controlled Clinical Settings (News Release), White Oak, MD, August 10, 2020, FDA, Accessed August 10, 2020

The FDA has approved olicerdine (Olinvyk, Trevena) for use in patients with severe pain who require an IV opioid when alternative treatments prove to be inadequate. 

All News