The Coronavirus resource center provides clinical news and articles, coverage from conferences and meetings, links to condition-specific resources, and videos and other content.

Visit Our Coronavirus Resource Center

An oral liquid containing acetaminophen, Genexa’s new fever and pain medication for infants is the newest in its clean medicine lineup. In addition to acetaminophen, it contains organic agave syrup, blueberry flavor, and citrus extract, as well as non–genetically modified organism flavor and purified water. The product joins the company’s other medicines for infants and newborns, including probiotics, saline nasal drops and spray, and vitamin D.

Nervive is a line of daily supplements designed to address nerve care and pain. It includes Nerve Health to fortify overall nerve health, as well as Nerve Relief and Nerve Relief PM for occasional aches, discomfort, and weakness related to aging. Nerve-related discomfort is especially common in aging adults because of natural structural changes in the nervous system, including loss of myelin and slowed signaling. To help address these changes, the supplements are specially formulated with ingredients to support patients’ fundamental functions and needs.

Designed to deliver apple cider vinegar in capsule form, Bragg Apple Cider Vinegar supplements offer 750 mg of acetic acid―the equivalent of 1 tbsp of liquid apple cider vinegar―in 3 capsules. Benefits of apple cider vinegar include appetite control and maintenance of healthy blood glucose and cholesterol levels. The supplements also include vitamin D and zinc and are available in 90-count bottles, according to a company statement.

With a line of 4 personalized nutrition packs to address specific health and wellness concerns, Nature’s Bounty aims to make daily supplement intake simple. Each pack contains 3 to 4 pills that are taken daily and are available in 4 varieties. A Good Night includes melatonin, L-theanine, and magnesium; Daily Essentials features an advanced multivitamin, high-dose vitamin C, and L-theanine; Master the Day includes Ginkgo biloba leaf extract, high-dose vitamin C, and super B complex; and Set the Foundation includes coenzyme Q10, Ginkgo biloba, and vitamin D. The supplements are available on Amazon and will be on retail pharmacy shelves later in the year.

Articles

This month's featured products include an infants' pain and fever reducer, daily supplements for nerve care and pain, and more. 

News

Retail

September 2021 OTC Product News

Pharmacy Times recently spoke with Andrea Silber, MD, the associate director for clinical research at the Center for Community Engagement and Health Equity within Smilow Cancer Hospital and Yale Cancer Center. In the interview, Silber said the COVID-19 pandemic has exacerbated disparities that already existed within oncology care, and she said the effects of these disparities on patients are very real and direct.

In addition, Silber said that although she's excited to see more data at the upcoming 2021 American Society of Clinical Oncology Annual Meeting, it is not enough to research and write about the disparities. Tackling these issues will require direct, intentional action.

Videos

Andrea Silber, MD, said the COVID-19 pandemic has exacerbated disparities that already existed within oncology care, and she said the effects of these disparities on patients are very real and direct.

Hospital

Oncology

Hematology

Tackling Disparities in Oncology Requires Action, As Well As Research

The FDA as approved ruxolitinib (Jakafi, Incyte) to treat chronic graft-versus-host disease (GVHD) after the failure of 1 or 2 lines of systemic therapy in individuals aged 12 years and older.

“GVHD is the leading cause of morbidity and mortality in patients following an allogeneic stem cell transplant, yet there historically have been limited treatment options available beyond first-line systemic therapies,” Steven Stein, MD, chief medical officer at Incyte, said in a statement.

Results of the REACH3 study showed that ruxolitinib had a better overall response rate (ORR) compared with the best available therapy for treatment of GVHD after allogeneic stem cell transplantation.

The ORR at week 24 was 49.7% for ruxolitinib compared with 25.6% for the alternative drug. The ORR through cycle 7, day 1, was 70% for ruxolitinib compared with 57% for the alternative drug.

“Incyte is proud to have contributed to the overall scientific understanding of GVHD through our REACH program, which has led to important treatment advances on behalf of patients and the medical community, including today’s approval of Jakafi for certain people who develop chronic GVHD,” Stein said.

The most common adverse reactions were anemia, thrombocytopenia, and viral infections.

The REACH3 study results were published in the 

GVHD can occur after an allogeneic stem cell transplant in which the donated cells initiate an immune response and attack the transplant recipient’s organs.

“In the U.S., there are over 14,000 people living with chronic GVHD, many of whom face significant complications that may impair daily activities and linger for years,” Susan Stewart, executive director at BMT InfoNet, said in the statement. “The approval of Jakafi is an exciting development for the GVHD community and an important step forward in the treatment of a disease with few options.”

Incyte announces FDA approval of Jakafi (ruxolitinib) for treatment of chronic graft-versus-host disease (GVHD). Business Wire. News release. September 22, 2021. Accessed September 23, 2021. 

https://www.businesswire.com/news/home/20210922005863/en

The overall response rate of ruxolitinib at week 24 was 49.7% compared with 25.6% for the best available therapy treatment for graft-versus-host-disease.

FDA Approves Jakafi to Treat Chronic GVHD

Pfizer and BioNTech have received the first FDA Emergency Use Authorization (EUA) for a COVID-19 booster shot, indicated for individuals 65 years of age and older, as well as for individuals of all ages who are at high risk of contracting severe COVID-19.

Individuals at high risk of severe COVID-19 include those whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at an elevated risk of serious complications from COVID-19, according to a Pfizer press release. The booster doses are to be administered at least 6 months after completion of the primary 2-dose series and are the same formulation and dosage strength as the original doses.

“This first FDA authorization of a COVID-19 vaccine booster is a critical milestone in the ongoing fight against this disease,” said Albert Bourla, DVM, PhD, chairman and CEO of Pfizer, in the press release. “Over the last year and a half, we have aimed to stay vigilant as the pandemic as evolved—including evaluating the impact of a booster dose. We believe boosters have an important role to play in addressing the continued threat of this disease, alongside efforts to increase global access and uptake among the unvaccinated.”

 from an FDA advisory committee, which did not recommend the booster shots for the broader public because they said more data are needed. However, the panel voted unanimously to recommend booster shots for adults over 65 years of age and those at high risk of severe COVID-19.

The EUA is based on data evaluating the safety, tolerability, and immunogenicity of a booster dose of the COVID-19 vaccine. According to the press release, clinical trials found that the booster dose elicited significantly higher neutralizing antibody titers against the wild-type SARS-CoV-2 virus, as well as the Beta and Delta variants, compared with titers observed after the initial 2-dose series.

These findings are from a phase 3 trial with 306 participants between 18 and 55 years of age who received a third dose of the vaccine between 4.8 months and 8 months after the primary 2-dose regimen. Researchers had a median follow-up time of 2.6 months post-booster and the neutralizing titers after the third dose met a prespecified 1.5-fold non-inferiority criterion of success and were statistically superior.

The reactogenicity profile within 7 days after the booster dose was typically mild to moderate, and the frequency of reactions was similar to or lower than after the second dose. The adverse event profile was generally consistent with earlier clinical safety data for the vaccine.

A third dose was previously authorized under the EUA for individuals at least 12 years of age who have undergone solid organ transplant or who have conditions resulting in an equivalent level of immunocompromise. This authorization is for a third dose administered at least 28 days following the second dose and is separate from the newly authorized booster dose.

“Today’s emergency use authorization is supported by clinical data underlining that a booster induced a strong immune response against tested variants of concern and can address a current public health need,” said Ugur Sahin, MD, CEO and co-founder of BioNTech, in the press release. “We will continue to monitor new SARS-CoV-2 strains, to be prepared for potential emerging escape variants.”

Pfizer and BioNTech Receive First US FDA Emergency Use Authorization of a COVID-19 Vaccine Booster. News release. Pfizer; September 22, 2021. Accessed September 23, 2021. 

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-receive-first-us-fda-emergency-use

The COVID-19 booster doses are to be administered at least 6 months after completion of the primary 2-dose series and are the same formulation and dosage strength as the original doses.

Coronavirus

FDA Issues Emergency Use Authorization for Pfizer, BioNTech COVID-19 Booster Vaccine

Intravenous (IV) treatment with remdesivir (Veklury; Gilead) significantly reduced the risk of hospitalization in high-risk patients who were diagnosed with COVID-19 but were not hospitalized, according to the results of a double-blind, placebo-controlled study.

Remdesivir is a nucleotide analog currently used as the antiviral standard of care for hospitalized patients with COVID-19. According to a Gilead press release, more than half of patients hospitalized with COVID-19 in the United States are treated with remdesivir because it directly inhibits viral replication of SARS-CoV-2.

“As the pandemic continues to evolve and new viral variants emerge, Veklury is playing a critical role as the antiviral standard of care for hospitalized patients, helping prevent disease progression and speed patients’ recovery,” said Merdad Parsey, MD, PhD, chief medical officer at Gilead Sciences, in the press release.

Researchers analyzed 562 participants who were randomly assigned 1:1 to receive either remdesivir or placebo. According to the press release, remdesivir demonstrated a statistically significant 87% reduction in risk for the composite primary endpoint of COVID-19-related hospitalization or all-cause death by day 28 compared with placebo.

Furthermore, the investigators found an 81% reduction in risk for the composite secondary endpoint of medical visits due to COVID-19 or all-cause death by day 28 for participants treated with remdesivir compared with placebo. No deaths were observed in either arm by day 28, according to the press release.

“Antiviral medications provide maximal benefit when used early in the disease course,” said Robert L. Gottlieb, MD, PhD, cardiologist and principal investigator at the Baylor University Medical Center, in the press release. “Last summer, data from clinical trials demonstrated the benefit of remdesivir in patients hospitalized with COVID-19, even when not yet requiring oxygen. These latest data show remdesivir’s potential to help high-risk patients recover before they get sicker and stay out of the hospital altogether.”

The researchers noted that enrollment for the trial was halted prior to fulfilling the enrollment targets in April 2021, due to changing epidemiology and adoption of new treatment options at the time. However, the researchers continued to collect data on enrolled participants and both the investigators and participants remained blinded.

In the trial, the safety profile was similar between remdesivir and placebo. The most common treatment-emergent adverse events in patients taking remdesivir were nausea and headache, and no new safety signals were identified among the 279 patients in the remdesivir arm. One death was observed in the study at day 59.

The use of a 3-day treatment cycle of remdesivir for the treatment of non-hospitalized patients with COVID-19 is investigational. The safety and efficacy for this use has not been established or approved by any regulatory agency globally. In the United States, remdesivir is FDA-approved for hospitalized adults and pediatric patients 12 years of age and older for the treatment of COVID-19.

“We are seeing very high numbers of hospitalized patients as new COVID-19 infections surge, placing increased demands on already overburdened health care systems,” Gottlieb said in the press release. “Remdesivir, also known as Veklury, is an effective antiviral for the treatment of hospitalized patients with COVID-19 and an essential tool to help reduce disease progression.”

Veklury (Remdesivir) Significantly Reduced Risk of Hospitalization in High-Risk Patients with COVID-19. News release. Gilead; September 22, 2021. Accessed September 22, 2021. 

https://www.gilead.com/news-and-press/press-room/press-releases/2021/9/veklury-remdesivir-significantly-reduced-risk-of-hospitalization-in-highrisk-patients-with-covid19

Remdesivir demonstrated a statistically significant 87% reduction in risk for the composite primary endpoint of COVID-19-related hospitalization or all-cause death by day 28.



Study: Remdesivir Significantly Reduces Risk of Hospitalization in High-Risk Patients with COVID-19

Most people who have genital herpes have no symptoms, or have very mild symptoms.

Herpes sores usually appear as one or more blisters on or around the genitals, rectum, or mouth.

Ten quiz questions to assess your knowledge on common symptoms and treatments for genital herpes.

Infectious Disease

Zoster

Pharmacy Quiz: Test Your Knowledge on Genital Herpes

The Moderna mRNA-1273 COVID-19 vaccine remains effective and safe for an average of 5.3 months after individuals receive the second dose, results of a clinical trial published in the 

The Coronavirus Efficacy (COVE) trial included 30,420 individuals at 99 US sites who were at severe risk of COVID-19 or whose location or circumstances put them at risk of COVID-19.

From July 27 to October 23, 2020, individuals were randomly assigned their first dose, with their follow-up 28 days after.

“Overall, we observed lower incidence rates of COVID-19 cases in July and August among participants vaccinated more recently, but it’s important to keep in mind that the numbers we are seeing are far from a decay back to original risk,” Lindsey Baden, MD, physician at the Division of Infectious Diseases at Brigham and Women’s Hospital, said in a statement.

After the FDA granted Moderna’s vaccine emergency use authorization, the COVE trial was amended to include 2 parts that monitored individuals who had already received the vaccine and administered the vaccine to those who received the placebo.

“The rapid redesign of the COVE study allowed us to successfully maintain participants in the study and will allow us to study longer-term safety and efficacy,” Baden said. “Using established and novel study methods, we’ve been able to continue to compare outcomes for those who were vaccinated earlier versus later in the study population.”

After 14 days since the second dose, investigators found that the vaccine was 93.2% effective against COVID-19 compared with the placebo group.

Prevention remained consistent throughout the follow-up, with efficacy greater than 90% 4 or more months after the second dose.

“Overall, our results continue to demonstrate that vaccines work and work extremely well at preventing COVID-19,” Baden said.

“We are continuing to explore questions about duration of immunity following vaccination and the impact of variants. But even as we examine the possibility of waning immunity, we see evidence that the vaccine is still very protective,” Baden said.

Safety was also continuously assessed in the group, with adverse events 7 days after vaccination, such as fatigue, headaches, joint pain, and muscle aches.

Vaccine efficacy was also high in individual subgroups such as aged 65 years or older, aged 75 years or older, different ethnical and racial groups, individuals with comorbidities, and those with occupational risk exposure.

“The message here is not that if you were vaccinated early, you’re not protected. Those vaccinated more recently may be experiencing a marginal improvement, but both groups are benefitting from protection compared to people who remain unvaccinated,” Baden said.

The same group of investigators also published results on 

 that explored the analysis of individuals who received the vaccine between July and December 2020 and those who received the placebo between December 2020 and March 2021.

Phase 3 trial results: mRNA-1273 vaccine continued to be safe and efficacious more than five months after second dose. EurekAlert. News release. September 22, 2021. Accessed September 23, 2021. 

https://www.eurekalert.org/news-releases/929287

It demonstrated 93.2% efficacy 14 days afterward and greater than 90% for 4 or more months.

Moderna COVID-19 Vaccine Remains Effective for 5.3 Months After Second Dose

Medication Pearl of the Day: Crizanlizumab (Adakveo)

Crizanlizumab is a selectin blocker indicated to reduce the frequency of vasoocclusive crises in adults and pediatric patients 16 years of age and older with sickle cell disease.

: Administer 5 mg/kg by intravenous infusion over a period of 30 minutes on week 0, week 2, and every 4 weeks thereafter.

 Injection: 100 mg/10 mL (10 mg/mL) solution in a single-dose vial.

 Most common adverse reactions (incidence > 10%) are nausea, arthralgia, back pain, abdominal pain, and pyrexia.

Crizanlizumab is a humanized IgG2 kappa monoclonal antibody that binds to P-selectin and blocks interactions with its ligands, including P-selectin glycoprotein ligand 1 (PSGL-1). Crizanlizumab can also dissociate preformed Pselectin/PSGL-1 complex. Binding P-selectin on the surface of the activated endothelium and platelets blocks interactions between endothelial cells, platelets, red blood cells, and leukocytes.

Crizanlizumab is a humanized IgG2 kappa monoclonal antibody that binds to P-selectin and blocks interactions with its ligands.

Daily Medication Pearl: Crizanlizumab (Adakveo) for Sickle Cell Disease

ALS is a disease that impacts the parts of the nervous system that control voluntary muscle movement.

ALS is the most common form of motor neuron disease.

As these motor neurons are lost, the muscles they control become weak and then nonfunctional, thus leading to muscle weakness, disability, and eventually death.

ALS usually strikes in late middle age (the late 50s is average) or later.

ALS results in muscles that are reduced in size (atrophic), weak, and soft, or muscles that are stiff, tight, and spastic.

Treatment options may include medications such as Rilutek, Radicava, breathing care, physical therapy, occupational therapy, speech therapy, nutitional and psychosocial therapy.

Amyotrophic Lateral Sclerosis (ALS) - Diseases | Muscular Dystrophy Association (mda.org)

Amyotrophic lateral sclerosis (ALS) - Diagnosis and treatment - Mayo Clinic

Specialty Pharmacy

Neurology

Pharmacy Clinical Pearl of the Day: Amyotrophic Lateral Sclerosis


Today's special episode marks the first part of our new series with NCPA, Independent Rx Forum, featuring Doug Hoey and Dr. Bri Morris! A host from Pharmacy Focus will be speaking with NCPA staff, leadership or other independent pharmacy experts about how the industry is changing, what these neighborhood pharmacies need to stay cutting-edge and sustainable into the future, and how NCPA works to support their success.

Podcasts

The Pharmacy Times® Pharmacy Focus podcast provides the latest industry news and information, thought-leader insights, clinical updates, patient counseling tools, and innovative solutions for the everyday practice and business of pharmacy.

Latest Clinical News