News Briefs

Galderma is introducing Epsolay (benzoyl peroxide) Cream 5%, a topical cream containing benzoyl peroxide 5% for the treatment of bumps and blemishes (inflammatory lesions) of rosacea in adults. 

The company said that the medication is the first and only microencapsulated benzoyl peroxide topical treatment proven to relieve the bumps and blemishes of rosacea and provide rapid, significant and sustained relief.

Over 16 million people in the United States struggle with rosacea, a chronic and recurrent skin condition that can worsen over time. More than 82% of people feel their rosacea is uncontrolled, and less than 50% are satisfied with their current prescription treatments, which can lead to overuse or misuse of these products and can trigger or worsen the condition. Rosacea can be so challenging to manage that 55% of people with the skin condition and a high disease burden reported a willingness to give up one year or more of their life to cure their symptoms, the company said.

"Through our decades-long heritage in dermatology and skin science, Galderma is committed to bringing cutting-edge innovation to patients with rosacea and the healthcare professionals who treat them," said Anthony Pansy, vice president and general manager of the U.S. prescription business at Galderma. "Epsolay Cream represents an important advancement for those who are living with this incredibly challenging skin condition."

A month's supply of Epsolay Cream costs as little as $0 for commercially covered patients with the Galderma CAREConnect savings card at participating pharmacies, according to Galderma.

"Until now, BPO has never been indicated to treat rosacea in part due to its poor tolerability for sensitive skin. Epsolay Cream helps overcome tolerability issues via its patented microencapsulation technology, which controls the gradual release of BPO onto the skin," said Ted Lain, executive director of the Austin Institute for Clinical Research and principal investigator for the Epsolay Cream clinical trials. "Epsolay Cream showed great efficacy and tolerability in the pivotal trials, as evidenced by high patient satisfaction and compliance."

The medication utilizes a proprietary, patented technology licensed from Sol-Gel Technologies to encapsulate BPO within silica-based microcapsules to create a barrier between the medication and the skin. The silica-based shell is designed to slowly release BPO over time to provide a tolerable and effective treatment.

Sol-Gel Technologies received FDA approval for Epsolay Cream on April 22, 2022 and has granted exclusive rights to Galderma to commercialize the treatment in the United States.

Ancient Nutrition is debuting its new Herbal Cider Vinegar product, which is set to be available in tincture, gummies and capsule formats.

The formula contains the time-honored genius of apple cider vinegar plus a regenerative organic-certified superfood blend of 10 fermented and antioxidant-rich herbs, spices and berries, the Nashville, Tenn.-based company said.

Included in the product’s formulation is organic and uncultured apple cider vinegar that is infused with fermented herbs, spices and berries such as turmeric, goji berry, sumac berry, guava, passionfruit, elderberry fruit, moringa leaf, holy basil leaf, feijoa and key lime.

“Apple cider vinegar has been used for its health-promoting benefits for centuries. Using the power of apple cider vinegar to amplify the benefits of time-honored and revered herbs and spices creates an incredible synergy. Simply put, Herbal Cider Vinegar takes ACV and herbs to the next level!” said co-founder of Ancient Nutrition Dr. Josh Axe. “Fermenting traditional superfoods such as herbs, spices, roots and berries in a raw vinegar culture is an ancient process that is an effective way to capture their beneficial properties. That’s what makes our Herbal Cider Vinegar a one-of-a-kind product that has benefits beyond measure.”

In addition, the Herbal Cider Vinegar product has also been designed to provide users with 3-in-1 benefits that include supporting healthy microbial balance, promoting healthy antioxidant levels, supporting healthy weight management, supporting healthy body composition, promoting cardiovascular health and function, and promoting healthy nutrient metabolism, the company said.

The Herbal Cider Vinegar capsules, tinctures and gummies retail for $24.95 each and will be available for purchase on Ancient Nutrition’s website and Amazon.

The majority of responding pharmacists (66%) would be prepared to administer COVID-19 vaccines to children under 5 years old if authorized to do so, according to a recent survey of pharmacists conducted by the American Pharmacists Association.

Nearly half of respondents (44%) said they are currently planning to vaccinate based on community needs and abilities of pharmacy teams following FDA and CDC authorization and guidance. Pharmacists’ level of vaccination engagement for this age group will be an individual practice and practitioner decision. As always, pharmacists stand ready to work with other immunization stakeholders, APhA said.

“The data show that pharmacists are again poised to contribute to our nation’s health efforts and vaccinate all Americans against COVID-19,” said Scott Knoer, APhA executive vice president and CEO. “This has been true since the first COVID-19 vaccines arrived in December 2020, and it continues to be the case today despite the enormous challenges facing pharmacists in every practice venue.”

CDC recently reported that 70% of COVID-19 vaccinations have occurred in pharmacies, including 60% of adolescent vaccinations and 46% of vaccinations in children 5 to 11 years old.

The survey of 612 pharmacists was conducted from Feb. 12, 2022 to March 1, 2022, with respondents from all regions of the country and representing a wide range of practice types, including chain pharmacies, independent pharmacies and supermarket pharmacies. The margin of error in this survey is ±3.9% at the 95% confidence level.

Summer is just around the corner, and Babyganics is offering the proper sun protection for children and toddlers.

The San Francisco-based company is expanding its mineral sunscreen line with two new products that are designed for easy application:

• B Kids SPF 50 Non-Aerosol Sunscreen Spray, featuring a continuous mist, is designed for application on such larger body parts as arms, backs and legs; and
• Babyganics Kids Roll On 50 SPF, ideal for those itty-bitty-tricky-to-reach places, the rollerball is able to run in easily into such areas as ear lobes and the tops of feet to provide smooth coverage.

Made with an all mineral active ingredient formula that is free of parabens, phthalates, PABA, fragrances and nanoparticles, each product offers broad-spectrum SPF 50 UVA/UVB protection. They are also sweat- and water-resistant up to 80 minutes, dermatologist tested, pediatrician tested, non-allergenic, tear-free and not tested on animals, the company said.

Babyganics’ new mineral sunscreen spray and roll-on are available online, as well as at retailers nationwide.

Hyland’s Naturals is unveiling a new line of gummies that fall into the vitamins, minerals and supplements category.

Featuring four new preventive health supplements for adults and children, the organic and vegan gummies are formulated to target specific health goals that range from immune support and stress relief to digestive health, the company said.

“Hyland’s Naturals has been a trusted wellness brand with families for more than a century, and we’re thrilled to now offer customers our high-quality gummy supplements for preventative health,” said Will Righeimer, CEO of Hyland’s Naturals. “Not only do our gummy supplements taste delicious, but they are also manufactured in the USA to ensure the highest level of safety and quality for our consumers.”

The new gummies include:

• Organic Elderberry Plus, a daily immune support product that contains black elderberry, vitamin C and zinc;
• Kids Organic Elderberry Plus, a daily immune support supplement with organic black elderberry, vitamin C and zinc;
• Organic Apple Cider Vinegar Blast, a supplement formulated to support digestive health with such antioxidants as apple cider vinegar; and
• Stress Busters, made with L-theanine, lemon balm and chamomile. It provides a nondrowsy solution to quiet the mind for relaxation or focus.

Consumers can find Hyland’s Naturals’ new supplements at more than 15,000 retail locations, six countries and all major e-commerce sites this quarter, the brand said.

The Food and Drug Administration has granted Roche a label extension for Evrysdi (risdiplam) to include babies under two months old with spinal muscular atrophy.

SMA is a severe, progressive neuromuscular disease that can be fatal. It affects approximately one in 10,000 babies and is the leading genetic cause of infant mortality. SMA is caused by a mutation of the survival motor neuron 1 gene, which leads to a deficiency of SMN protein. This protein is found throughout the body and is essential to the function of nerves that control muscles and movement. Without it, nerve cells cannot function correctly, leading to muscle weakness over time. Depending on the type of SMA, an individual’s physical strength and their ability to walk, eat or breathe can be significantly diminished or lost.

“The approval of Evrysdi for pre-symptomatic babies is particularly important, as early treatment of SMA, before symptoms start to arise, can help babies to achieve motor milestones,” said Richard Finkel, Rainbowfish principal investigator and director of the Experimental Neuroscience Program at St. Jude Children’s Research Hospital. “With the inclusion of SMA in newborn screening programs, this approval provides the opportunity to start treating at home with Evrysdi soon after the diagnosis is confirmed.”

“The priority review and subsequent approval of Evrysdi for babies under two months of age speaks to the urgent ongoing need for additional treatment options for babies with SMA,” said Levi Garraway, Roche’s chief medical officer and head of global product development. “Because of its efficacy in multiple settings, Evrysdi is now available for people with SMA from pre-symptomatic newborns to older adults. We are proud of this achievement, which has the potential to make a real difference to those living with SMA and their caregivers.”

Evrysdi is a survival motor neuron 2 splicing modifier designed to treat SMA caused by mutations in chromosome 5q that lead to SMN protein deficiency. Evrysdi is administered daily at home in liquid form by mouth or by feeding tube.