Kevin Kunzmann

Verrica Pharmaceuticals has resubmitted the New Drug Application (NDA) for investigative topical therapy VP-102 for the treatment of 

The latest submission to the US Food and Drug Administration (FDA) comes after the company received a 

 for its NDA in 2021, at which time the agency identified issues with a contract manufacturing organization (CMO) facility relevant to the drug. However, Verrica denied the facility in question was specifically related to the manufacturing of VP-102. They additionally noted the FDA had not identified deficiencies related to the product’s clinical, safety, chemistry, manufacturing or control characteristics in the CRL.

With the announced NDA resubmission, Verrica highlighted a “successful tech transfer” of bulk solution manufacturing to resolve the CRL issue. “We look forward to working with the FDA through the review process, and if approved, bringing VP-102 to patients as the first FDA-approved treatment option for molluscum,” Verrica president and chief executive officer Ted White said in a statement.

VP-102 is a drug-device combination therapy featuring a single-use, topical, targeted application of 0.7% w/v cantharidin to treat molluscum. 

Pooled analysis of a pair of phase 3 trials

 assessing the agent in pediatric and adult patients with molluscum showed mean lesion counts in treated patients decreased by 76%, versus just 0.3% in patients treated with vehicle at day 84 (

 <.0001). Approximately half of all patients to receive VP-102 achieved complete molluscum lesion clearance at day 84 (

Common adverse events associated with VP-102 were mild-to-moderate application site blistering, pruritus, pain and erythema.

Molluscum is a highly contagious viral skin infection caused by pox virus that results in painful, inflammatory and irritated lesions. Untreated cases can last for a mean 13 months, or up to several years. A majority of the approximate 6 million patients in the US are children, and no treatment is currently approved by the FDA.

VP-102 is additionally being assessed for the treatment of common warts and external genital warts, with Verrica having recently completed phase 2 clinical trials for both patient populations.

This article was published by our sister publication HCP Live.

Articles

After addressing a 2021 CRL, Verrica Pharmaceuticals vies for the agent to become the first drug approved to treat the common skin infection.

VP-102 resubmitted to FDA for molluscum contagiosum approval

The legalization of cannabis in Canada, and corresponding availability of edible cannabis products, was associated with a major increase in the rate of poisoning-related 

There has been a clear correlation between the availability of legal cannabis and edible products and a rising prevalence of unintentional pediatric cannabis-related poisonings since 2018, according to new data from investigators at Ottawa Hospital Research Institute. Findings from their cross-sectional analysis of pediatric hospitalizations show the correlation is significant enough that cannabis is now a nationally leading cause of pediatric poisoning hospitalizations—an issue that investigators warned may burden countries with increasing cannabis legalization and marketing such as the United States.

Led by Daniel T. Myran, MD, MPH, investigators sought to analyze the change in rate of all-cause poison hospitalizations due to cannabis in children aged 0-9 years old across Canada’s 4 most populous provinces throughout a series of 3 legalization policy periods from the last 8 years.

Citing ongoing discussions among the US Senate to federally legalize recreational cannabis, the team noted a growing field of evidence that cannabis legalization is positively correlated with pediatric cannabis poisonings; such cases generally present with concerning, high-acuity conditions including decreased consciousness, respiratory depression and seizures.

Canada legalized recreational cannabis for adults ≥18 years old in October 2018, using a 2-phase strategy that allowed provinces to permit or prohibit sale of expanded commercial edible products alongside mandatory dried cannabis flower; Ontario, British Columbia and Alberta permitted sale of cannabis edibles and THC-infused beverages in January 2020, while Quebec prohibited sale of edible products that included candies, sweets and products that would be potentially attractive to children and young adults.

As such, investigators analyzed these 4 provinces—the most populous in Canada—across 3 states of legalization: pre-legalization (January 2015 – September 2018); period 1, representing legalized dried flower (October 2018 – December 2019); and period 2, representing legalized dried flower and edibles in the 3 provinces (exposed provinces) and restriction in Quebec (control province) (January 2020 – September 2021).

Myran and colleagues observed 581 pediatric hospitalizations for cannabis poisoning from 2015 – 2021; a majority of patients were boys (53.9%), and mean age was 3.6 years old. Investigators additionally observed another 4406 hospitalizations for all-cause poisonings.

Among the all-cause poisoning hospitalizations, the rate per 1000 hospitalizations due to cannabis poisoning was 57.42 in exposed provinces and 38.5 in the control province. In period 1, following legalization, the rate per 1000 poisoning hospitalizations increased to 149.71 in exposed provinces (incidence rate ratio [IRR], 2.55; 95% CI, 1.88 – 3.46) and to 117.52 in the control province (IRR, 3.05; 95% CI, 1.82 – 5.11).

In period 2, when the exposed provinces permitted edibles, the rate per 1000 poisonings due to cannabis again more than doubled to 318.04 among exposed provinces (IRR, 2.16; 95% CI, 1.68 – 2.80), but remained at a similar rate of 137.93 in Quebec (IRR, 1.18; 95% CI, 0.71 – 1.97).

With approximately 1 in every 3 pediatric poisoning hospitalizations involving cannabis in provinces with legalized dry leaf and edible cannabis products, Myran and colleagues stressed these findings may provide state- and country-level legislators insight into best policies and strategies in place to mitigate risk in places where cannabis is legalized.

“Our findings of disparate proportions of pediatric poisonings in Quebec and Ontario, despite the comparable overall dollar value of legal cannabis sales during the study, suggest that product type rather than sales volume is a key factor associated with pediatric poisonings,” they wrote. “The large increase in harms associated with the sale of commercial cannabis edibles and concentrates in exposed jurisdictions suggests that restricting or prohibiting the sale of these products could be a highly effective regulatory act to reduce the frequency and severity of unintentional pediatric poisonings.”

They additionally recommended consideration of child-resistant or unit-dose packaging to avoid overexposure risk, as well as increased public health messaging around the risk of pediatric cannabis consumption. Indeed, a key facet to reducing the impact of cannabis legalization on pediatric hospitalizations is in the very marketing and promotion of the product.

“Our findings suggest that placing restrictions on the sale of visually attractive and palatable commercial cannabis edibles is a key strategy and policy consideration for preventing unintentional pediatric cannabis poisonings for the US and other countries considering legalization of recreational cannabis,” they wrote.

Pediatric Hospitalizations for Unintentional Cannabis Poisonings and All-Cause Poisonings Associated With Edible Cannabis Product Legalization and Sales in Canada

This article was published by out sister publication HCP Live.

A cross-sectional study showed cannabis ingestion has been the cause of 1 in every 3 pediatric poisoning hospitalizations in provinces that sell edibles.

Pediatric cannabis poisoning hospitalizations spiked in Canada after edible legalization

About 6% of pediatric patients hospitalized with influenza during the 2021–22 season suffered from a 

 coinfection, according to new data from the Centers for Disease Control and Prevention (CDC).

Findings from surveillance data show a greater rate of pediatric patients with said coinfection were more likely to require respiratory support than those hospitalized with lone influenza. They were also more likely to die from their hospitalization.

A team of CDC investigators, led by Katherine Adams, MPH, of the Influenza Division at the National Center for Immunization and Respiratory Diseases, conducted an analysis of available national data on COVID-19- and influenza-associated hospitalizations to interpret the burden of overlap infection and outcomes among US pediatric patients amid the coinciding 2020-21 flu season and COVID-19 pandemic. The team conducted their assessment at a time when the 2022-23 flu season has shown an early climb in pediatric hospitalizations, as well as sustained SARS-CoV-2 circulation.

“The current influenza season is the first with substantial co-circulation of influenza viruses and SARS-CoV-2,” investigators wrote. “Although both seasonal influenza viruses and SARS-CoV-2 can contribute to substantial pediatric morbidity, whether coinfection increases disease severity compared with that associated with infection with one virus alone is unknown.”

The team assessed patients aged <18 years old who had been hospitalized or died with influenza per 3 CDC surveillance platforms used during the 2021-22 flu season (October 3, 2021 – October 1, 2022).

Among the 575 pediatric influenza-associated hospitalizations observed, 32 (6%) involved a SARS-CoV-2 coinfection. A majority of patients with either coinfection (56%) or lone influenza (58%) reported underlying medical conditions (

 = .81). Just 17% of coinfected patients were vaccinated against seasonal influenza, versus 42% of those with lone influenza (

Investigators additionally observed a greater proportion of patients with coinfection receiving invasive mechanical ventilation (13%) than those with lone influenza (4%; 

 = .03). Such patients additionally had a nearly three-fold greater occurrence of BiPAP or CPAP use than lone influenza patients (16% vs 6%; 

 = .05). However, there were no significant differences found between the two cohorts in prevalence of intensive care unit (ICU) admission.

The team’s data accounted for 44 influenza-associated pediatric deaths during the 2021-22 US flu season; 7 (16%) decedents had a coinfection of SARS-CoV-2. Among those who died and with available data, 0 of 6 with coinfections and 5 of 31 (16%) with lone influenza had been vaccinated for seasonal influenza (

The most common health complications among pediatric decedents with coinfections were pneumonia, acute respiratory distress syndrome, and bronchiolitis.

Cardiomyopathy or myocarditis occurred in 5 of 32 (16%) decedents with influenza and none with coinfection (

Though the findings only represent “a small number of cases of influenza and SARS-CoV-2 coinfection,” investigators concluded their findings elucidated the infrequency of coinfection among hospitalized children without underlying medical conditions—but also the increased need for invasive and noninvasive mechanical ventilation among such impacted patients.

“These findings also highlight the underuse of influenza antivirals and seasonal influenza vaccines, particularly among persons aged <18 years with influenza virus and SARS-CoV-2 coinfections who died,” investigators wrote.

The team concluded that respiratory virus prevention and mitigation during this cocirculation of SARS-CoV-2 and influenza requires public awareness of the risk of pediatric coinfection. They added that prevention strategies including masking and up-to-date vaccination for children should be adopted during the season of circulating viruses.

“To identify coinfections with influenza virus and SARS-CoV-2, clinicians should follow recommended testing algorithms for patients with acute respiratory illness symptoms in outpatient, emergency department, and hospital settings,” they wrote. “Clinical guidance on early initiation of antiviral treatment for influenza and SARS-CoV-2 should be followed for pediatric patients with suspected or confirmed influenza or SARS-CoV-2 infections (or both), who are hospitalized, have severe or progressive disease, or are at increased risk for complications.”

Prevalence of SARS-CoV-2 and Influenza Coinfection and Clinical Characteristics Among Children and Adolescents Aged <18 Years Who Were Hospitalized or Died with Influenza — United States, 2021–22 Influenza Season

New surveillance data from the 2021-22 influenza show the impact of coinfection among younger patients.

COVID-19, flu coinfection in children can require more respiratory ventilation use

 intervention for the prevention of obesity provides is more cost-effective for infants in low- and mid-socioeconomic positions (SEPs) compared to infants from greater socioeconomic groups, according to new findings.

In new economic evaluation data from a team of Australia and New Zealand investigators, infants from low and mid-SEPs were very likely to achieve cost-effective outcomes from a series of simple sleep intervention strategies provided to their patients. The findings support policy-level strategies to address health inequities given both positive economic and clinical outcomes.

Led by Dr. Anagha Killedar, a research fellow at the Menzies Center Health Policy & Economics at the University of Sydney, investigators sought to examine the cost-effectiveness of the Prevention of Overweight in Infancy (POI) trial sleep intervention delivered to parents of infants ≤2 years old, based on patient SEP groups. The POI trial showed that an intervention including parental sleeping arrangement and feeding pattern advice; settling technique guidance; partial sleep intervention; and modified sleep techniques for parents were associated with reduced body mass index (BMI) in infants as well as cost-effectiveness.

However, existing evidence regarding clinical and cost-effectiveness in childhood obesity intervention based on SEP groups is mixed.

“Socioeconomic inequality in the prevalence of childhood over- weight and obesity is a stubborn problem in many countries,” investigators wrote. “Recent national health surveys have shown that obesity prevalence among children in low socioeconomic areas is twice that in high socioeconomic areas in Australia and New Zealand. Furthermore, there is concern that these inequalities are increasing over time.”

Killedar and colleagues conducted the SEP-specific economic evaluation of the POI sleep intervention by deriving intervention costs and overall effects at patients through age 5 via the original trial data. They then applied the data to a population-representative cohort of 4898 Australian children aged 4-5 years old.

The team then simulated quality-adjusted life years and health care costs through age 17 in the cohort via a purpose-build SEP-specific model. Cost-effectiveness rations and acceptability curves were derived for each of low-, mid- and high-SEP groups.

Investigators observed that incremental cost-effectiveness ratios, in Australian dollars per quality-adjusted life year gained per patient, were smaller among low- and mid-SEP group infants: $23,010 and $18,206, respectively. Among high-SEP group infants, the ratio was $31,981 per life year gained. They additionally noted very strong cost-effective probabilities among the low- and mid-SEP groups (92% - 100%) compared to the high-SEP group (79%).

“The findings of this study bear important implications for decisions on how best to target the sleep intervention,” investigators wrote. “As the intervention is highly cost-effective in the low- and mid-SEP groups, and the needs of the low-SEP group are the highest (having the highest rates of overweight and obesity), an approach that targets the intervention to low-SEP groups would satisfy both efficiency and equity objectives. The decision-maker would not need to make any trade-offs between these goals.”

The team concluded their findings support evidence for policies that may address health inequities—noting that the observed correlation between cost-effectiveness of an early-childhood sleep intervention and SEP shows a “trade-off between efficiency and equity would not need to be made if choosing to target low-SEP groups.”

“To promote policy approaches that address inequities, ana- lyses such as these should be conducted routinely for candidate interventions,” investigators wrote. “Further work is needed in the reporting of intervention effect sizes by SEP, health care usage by SEP, and the collection of intervention resource use and SEP measures at an individual level to allow for routine stratified economic evaluations of interventions.”

The study, “Is the cost-effectiveness of an early-childhood sleep intervention to prevent obesity affected by socioeconomic position?,” was published online in 

An economic analysis of a clinical sleep intervention suggests it may provide a step toward improved health equity.

Early childhood sleep intervention is more cost-effective for lower socioeconomic groups

Apremilast was associated with reduced psoriasis severity among pediatric patients who previously were unable to control their disease with standard therapy, according to new data.

 this week, a team of multinational investigators reported that the oral PDE4 inhibitor was significantly efficacious in patients aged 6-17 years old with moderate-to-severe psoriasis, while maintaining a safety and tolerability profile to that observed in prior assessments.

The 16-week results from the phase 3 SPROUT trial would support the progression of investigation into the drug for younger patients than its current US Food and Drug Administration (FDA) indication.

Led by Loretta Fiorillo, MD, of the Stollery Children’s Hospital at the University of Alberta in Canada, investigators conducted a multi center, double-blind, placebo-controlled parallel study to analyze apremilast’s efficacy and safety in pediatric patients with moderate-to-severe plaque psoriasis inadequately controlled by or intolerant to topical steroids.

As they noted, akpremilast has already been approved practically globally for treating adults with psoriasis—as well as other inflammatory diseases including psoriatic arthritis and oral ulcers linked to Behcet’s disease.

“Since FDA approval in 2014, apremilast has consistently demonstrated a favorable benefit-risk profile in 706,585 adult patients worldwide across the approved indication,” they wrote.

The team enrolled patients aged 6-17 years old and randomized them 1:2 to apremilast 20 mg or 30 mg dependent on baseline weight, or placebo, through 16 weeks. They sought a primary endpoint of static physician’s global assessment (sPGA) response, defined as scores of 0 or 1—indicating clear or almost clear skin—or score improvements of ≥2 points since baseline at week 16.

They additionally sought a major secondary endpoint of Psoriasis Area Severity Index (PASI)-75 response at week 16.

Their trial results at 16 weeks included 163 patients administered apremilast versus 82 administered placebo. Mean patient age was 12.2 years old; 52.2% were female, and mean weight was 52.0 kg. Patients had had psoriasis for a mean duration of 4.2 years, and approximately three-fourths (75.5%) had sPGA scores of 3 at baseline. Mean PASI scores were 19.8 at baseline.

Investigators observed a three-fold increased rate of patients on apremilast achieving the primary endpoint of sPGA response at 16 weeks (33.1%) versus those on placebo (11.5%)—a 21.7% treatment difference (95% CI, 11.2 - 32.1; 

In the secondary endpoint, they again observed a three-fold increased rate of apremilast patients achieving PASI-75 at week 16 (45.4%) than patients given placebo (16.1%); the treatment difference was 29.4% (95% CI, 17.8 - 40.9; 

There were no significant differences in primary nor secondary endpoint achievement among apremilast patients based on patient baseline age or weight, investigators noted.

Fiorillo and colleagues observed a safety profile consistent with past assessments of apremilast; approximately two-thirds (65.0%) of treated patients reported any treatment-emergent adverse event. Two such events were deemed severe by clinical grade, and 5 patients withdrew from the trial due to an akpremilast-related adverse event. The most common burden among treated patients was gastrointestinal disorders including diarrhea.

Regardless, the team concluded that no new safety signals for the PDE4 inhibitor were observed in the pediatric population, and its significant benefit in efficacy across various age and weight groups gives promise to its potential utility in managing difficult-to-treat pediatric psoriasis.

“There are limited treatment options for pediatric patients with moderate to severe plaque psoriasis,” they wrote. “In this randomized placebo-controlled study, oral apremilast demonstrated effectiveness and was well tolerated in pediatric patients with moderate-to-severe plaque psoriasis.”

The study, “Efficacy and Safety Results of Apremilast in Pediatric Patients With Moderate to Severe Plaque Psoriasis: 16-Week Results From SPROUT, a Phase 3, Randomized, Controlled Study,” was presented at Fall Clinical 2022.

New 16-week data from the SPROUT trial show the PDE4 inhibitor may be highly efficacious in children and adolescents.

Apremilast may significantly, safely benefit severe pediatric psoriasis

Tralokinumab provides both symptom and psychosocial benefit for adolescent patients with moderate to severe 

 over 16 weeks, according to new findings.

In new data derived from the phase 3 ECZTRA clinical trial program for the interleukin 13 (IL-13) inhibitor agent, a team or US investigators reported improved sleep, anxiety and depression, and quality of life associated with the disease among treated adolescents.

The findings further support use of the LEO Pharma drug—recently approved by the US Food and Drug Administration (FDA) for adults with atopic dermatitis—as a comprehensive benefit for adolescents whose psychosocial factors may be heightened due to the chronic skin disease.

Led by Weily Soong, MD, a physician at the AllerVie Health - Alabama Allergy & Asthma Center, investigators evaluated the effect of tralokinumab on patient-reported outcomes in the ECZTRA 6 trial through 16 weeks. Previously, the phase 3 study showed tralokinumab provided “substantial efficacy” and good tolerability in adolescent patients.

Their patient population included 301 adolescents aged 12-17 years old randomized to receive either subcutaneous tralokinumab 150 mg (n = 100), 300 mg (n = 101), or placebo (n = 100) once every 2 weeks. Key patient-reported outcomes included:

Itch per worst pruritus Numeric Rating Scale (NRS)

Sleep interference per eczema-related sleep NRS

Children’s Dermatology Life Quality Index (CDLQI)

Hospital Anxiety and Depression Scale (HADS)

Trial participants who received rescue therapy or had missing data were defined as non-responders.

Investigators observed significantly greater proportions of patients receiving either dose of tralokinumab achieving a ≥4 point improvement in adolescent worst pruritus NRS:

Investigators additionally observed ≥6 point improvements in CDLQI in 31.0% (

 <.001) of the tralokinumab arm, respectively, versus 15.9% of the placebo arm. Another 38.7% (

 <.001) of the tralokinumab treatment arms reported ≥6 point improvement in poem versus 10.5% of the placebo arm.

Similarly to the other outcomes, tralokinumab was associated significant improvements in eczema-related sleep NRS and mean change in HADS versus placebo.

“Tralokinumab significantly improved symptomatic and psychosocial impacts of moderate to severe atopic dermatitis in adolescents using clinically relevant patient-reported outcomes at week 16, including itch, sleep interference, anxiety/depression, and overall quality of life,” they concluded.

The study, “Tralokinumab Treatment Substantially Improves Patient-Reported Outcomes in Adolescents with Moderate-to-Severe Atopic Dermatitis at 16 Weeks,” was published online in 

Originally published on our sister brand, 

New data from ECZTRA 6 show improved sleep quality, itch relief and quality of life among teenagers treating atopic dermatitis with the IL-13 inhibitor.