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FDA Approval of Nonsteroidal Treatment for Duchenne Muscular Dystrophy
Breaking news! FDA approves Duvyzat for Duchenne Muscular Dystrophy, a nonsteroidal treatment providing hope for patients and families. #DMD #FDAApproval
Last Updated on March 21, 2024 by Daily News Staff
Breaking news in the medical world! The U.S. Food and Drug Administration has just approved Duvyzat (givinostat), an oral medication for the treatment of Duchenne Muscular Dystrophy (DMD) in patients six years of age and older. Duvyzat is making history as the first nonsteroidal drug approved to treat patients with all genetic variants of DMD. This is a significant milestone in the treatment of this devastating disease.
DMD, being the most common childhood form of muscular dystrophy, primarily affects males. It is a neurological disorder that leads to progressive muscle weakness due to a lack of dystrophin, a muscle protein. Over time, the muscles deteriorate, causing difficulties with walking, muscle strength, and eventually leading to breathing problems and early death. However, with advancements in treatment, the life expectancy for individuals with DMD has been steadily increasing, with some patients surviving beyond 30 years.
Duvyzat is a histone deacetylase (HDAC) inhibitor that targets pathogenic processes to reduce inflammation and loss of muscle in patients with DMD. Its efficacy for the treatment of DMD was evaluated in an 18-month phase 3 study involving a randomized, double-blind, placebo-controlled trial. The primary endpoint of the study was the change in muscle function, measured by the time it took patients to climb four stairs. Patients treated with Duvyzat showed a statistically significant reduction in the decline of muscle function compared to placebo.
Another measure of efficacy was the change in physical function assessed by the North Star Ambulatory Assessment (NSAA), a scale commonly used to rate motor function in boys with DMD who can still walk. Patients treated with Duvyzat experienced less worsening in their NSAA scores after 18 months, compared to those on placebo.
Like any medication, Duvyzat does come with some potential side effects. The most common ones reported were diarrhea, abdominal pain, a decrease in platelets, nausea/vomiting, an increase in triglycerides, and fever. It’s important for healthcare providers to evaluate a patient’s platelet counts and triglyceride levels before prescribing Duvyzat. Patients with low platelet counts should not take the drug. Monitoring of platelet counts and triglycerides throughout treatment will help determine if any dosage adjustments are needed.
Healthcare professionals should also be aware that Duvyzat may cause QTc prolongation, which can increase the risk of irregular heartbeats. It’s crucial for patients taking other medications known to cause QTc prolongation or with certain types of heart disease to avoid taking Duvyzat.
The recommended dosage of Duvyzat is determined by the patient’s body weight, and it should be taken orally twice daily with food.
The approval of Duvyzat was granted to Italfarmaco S.p.A., and it received priority review, fast-track designation, as well as orphan drug and rare pediatric disease designations from the FDA. This demonstrates the agency’s commitment to advancing the development of new therapies for DMD and its recognition of the urgent need for effective treatments.
This milestone approval represents hope and progress for individuals and families affected by DMD. It provides another treatment option to help reduce the burden of this progressive and debilitating disease, regardless of the specific genetic mutation. With continued advancements in medical research and the dedication of organizations like the FDA, we are moving closer to a future where individuals with DMD can lead healthier lives.
As always, it’s important to consult with healthcare professionals for more information and guidance regarding Duvyzat and its suitability for individual cases. Let’s celebrate this achievement in medical science and look forward to more groundbreaking developments in the treatment of Duchenne Muscular Dystrophy.
Source: FDA
Related Information
- Duchenne muscular dystrophy – About the Disease – Genetic and Rare Diseases Information Center
- The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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Last Updated on May 6, 2026 by Daily News Staff
Second Nature Brands has issued a voluntary recall for certain 10-ounce pouches of SECOND NATURE KETO CRUNCH SMART MIX™ after discovering the product may contain undeclared cashews, pistachios, and cherries. For anyone with allergies or severe sensitivities—especially to tree nuts like cashews and pistachios—this is a serious safety issue.
The company says the affected product was distributed nationwide, both in retail stores and through online orders.
Why this matters
Undeclared allergens are one of the most urgent types of food safety alerts because consumers rely on labels to avoid ingredients that can trigger reactions. Second Nature Brands warns that people with allergies or severe sensitivity to cashews, pistachios, other tree nuts, or cherries could face serious or life-threatening allergic reactions if they consume the recalled product.
As of the announcement, no illnesses have been reported.
How to identify the recalled product
Check your pantry (and any recent online snack orders) for the following details:
- Product: SECOND NATURE KETO CRUNCH SMART MIX™
- Size: 10-ounce pouch
- UPC: 077034013405
- Best if used by date: 2/12/2027 (printed on the backside of the pouch)
Only pouches with the “Best if used by 2/12/2027” date are included. Other Best if used by dates are not affected, according to the company.
What happened
Second Nature Brands says the recall began after it was discovered that product containing cashews, pistachios, and cherries was placed into packaging that did not disclose those allergens. The company reports that a follow-up investigation indicates the issue was caused by a temporary breakdown in production and packaging processes.
The recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).
What consumers should do right now
If you have the affected product:
- Do not consume it.
- Keep the pouch (and take a photo of the UPC and Best if used by date if helpful).
- Contact Second Nature Brands for a full refund.
Contact information for refunds and questions
Second Nature Brands says consumers can reach them by phone or email:
- Phone: +1.800.651.7263
- Monday–Friday: 8:00 AM–8:00 PM ET
- Saturday–Sunday: 9:00 AM–5:00 PM ET
- Email: recall@secondnaturebrandsus.com
Health & fitness note: “Keto” doesn’t equal “risk-free”
Keto-friendly snacks can be convenient for people managing carbs, training schedules, or busy workdays—but this alert is a reminder that label accuracy is non-negotiable, especially for anyone balancing nutrition goals with medical dietary restrictions.
If you or someone in your household has a tree nut or cherry allergy, consider doing a quick sweep of:
- Snack drawers at home and work
- Gym bags and travel kits
- Recent bulk orders or subscription deliveries
Bottom line
If you have a 10-ounce pouch of SECOND NATURE KETO CRUNCH SMART MIX™ with UPC 077034013405 and Best if used by 2/12/2027, do not eat it. Contact Second Nature Brands for a refund and share the alert with anyone who may have purchased the product—especially those with tree nut or cherry allergies.
Source
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Join the Fight Against ALS: Register and Make a Difference
Every year, doctors tell more than 5,000 Americans they have amyotrophic lateral sclerosis, better known as ALS. It is a life-changing diagnosis. In honor of ALS Awareness Month, learn more about the disease.
Join the Fight Against ALS: Register and Make a Difference
(Feature Impact) Every year, doctors tell more than 5,000 Americans they have amyotrophic lateral sclerosis, better known as ALS. It is a life-changing diagnosis.
Still, it’s hard to estimate the total number of ALS cases in the United States. No one knows what causes most cases of ALS, something the U.S. National ALS Registry is working to change.
In honor of ALS Awareness Month, learn more about the registry, how the information is used and how to enroll if you have ALS.
What is ALS?
ALS is a disease that affects the nerve cells that make muscles work in the body. This disease makes the nerve cells stop working and die. The nerves lose the ability to trigger specific muscles, which causes the muscles to become weak and leads to paralysis.
What is the registry?
“The National ALS Registry is a program of, by and for those living with ALS,” said Dr. Paul Mehta, principal investigator of the Registry. “The program collects, manages and analyzes data about people with ALS in the United States. It includes data and information provided by individuals who choose to register and complete the risk factor surveys.”
What is its purpose?
The main purpose is to gather information that can be used in the fight against ALS. The information is used to:
- Estimate the number of new cases of ALS diagnosed each year
- Estimate the number of people who have ALS at any given point in time
- Better understand who gets ALS and what factors affect the disease
- Enhance research that could improve care for people with ALS
How do researchers use the data?
Researchers can use the data to look for disease pattern changes over time and try to identify whether there are common risk factors among people with ALS. Since 2010, the registry has funded more than a dozen studies exploring potential ALS risk factors.
What does participation look like?
Individuals with ALS are encouraged to share their stories, enhancing ALS data and supporting research efforts. People living with ALS can help the National ALS Registry by completing up to 18 risk factor surveys, covering topics such as occupational history and environmental exposures, which help create a more complete picture of their ALS story.
How can someone join?
Anyone living with ALS can enroll. By joining and taking the risk factor surveys, individuals living with ALS can help future generations.
Get started at cdc.gov/als.
SOURCE:
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Lifestyle
Reclassification of marijuana opens doors for much‑needed medical research into the benefits and risks of the drug
The DOJ’s move to reclassify medical marijuana as Schedule III could unlock long-blocked cannabis research—while raising new questions about safety, regulation, and risk.
Carey S. Cadieux, Binghamton University, State University of New York
When the U.S. Department of Justice moved to reclassify medical marijuana to a Schedule III drug on April 23, 2026, it set the stage for a vast amount of medical research that has been hobbled for decades by its more restrictive Schedule I classification.
The Justice Department also called for an expedited federal rescheduling process, with proceedings expected to begin in late June 2026, but for now cannabis at the federal level remains a Schedule I drug.
I’m an associate professor of nursing and I edited a textbook for nurses about providing care with cannabis. Cannabis is the umbrella term for the plant genus that includes both marijuana and hemp – two varieties of the same plant distinguished primarily by their content of THC, one of the active components of cannabis.
Moving cannabis to a Schedule III drug ushers in the end of the cannabis prohibition era and the beginning of the regulation era, potentially creating promising opportunities around research and new therapeutics.
How are drugs regulated by ‘schedule’?
The Controlled Substances Act of 1970 categorizes all substances regulated under existing federal law into one of five schedules. The act regulates the manufacturing, importation, possession, use and distribution of substances on each schedule.
Several factors determine schedule placement, including the drug’s medical use, scientific evidence of its benefits and pharmacological effects, patterns and history of abuse, public health risk level, degree of physical or psychological addiction potential, and whether the drug can be used to make another controlled substance.
The Drug Enforcement Administration’s rescheduling of marijuana will move it from its current classification as a Schedule I drug, defined as having a high risk for abuse and no accepted medical use, to a Schedule III drug under the Controlled Substances Act. While still tightly regulated, Schedule III drugs are considered to have moderate to low risk for physical and psychological dependence and to have some medical benefits.
Other Schedule I drugs include heroin, psilocybin, LSD, peyote and MDMA, or ecstasy. These drugs cannot be dispensed or prescribed, with some exceptions. Current Schedule III drugs include ketamine, anabolic steroids, testosterone, products with less than 90 milligrams of codeine per dosage unit and some cannabinoids.
The move to reclassify medical marijuana products as Schedule III drugs applies only to those products certified by state-level medical cannabis programs. All other cannabis products remain a federal Schedule I drug, including those available from states’ recreational cannabis programs.
Impacts of cannabis reclassification
This legal order acknowledges that medical marijuana has some medical value and asserts that it has a lower potential for abuse than under the previous Schedule I classification.
The reclassification also ensures that state-registered medical cannabis patients continue to be permitted to purchase medical cannabis products without changes to their current certification or recommendation.
One of the challenges with this new law is that states have not standardized medical cannabis regulations, and each state will have its own quality and testing standards. In Maine, for instance, medical cannabis is not tested for molds, fungus, heavy metals or pesticides, while recreational cannabis is.
This means that the Schedule III medical cannabis in Maine could be contaminated, while the state’s testing of recreational cannabis makes it much safer to consume.
What are the implications for marijuana research?
For decades, researchers have struggled to conduct high-quality research studies due to their lack of access to the cannabis products that patients actually use and restrictions on their processes.
With the reclassification, researchers who are registered with the DEA to research cannabis will be able to obtain cannabis flower and plant material, as well as manufactured cannabis products, such as tinctures and edibles, directly from state-licensed businesses that are DEA-registered.
This means researchers will no longer need to rely on the federal DEA registry for access to cannabis products for research, which were often inferior in quality and variety in comparison to the everyday products medical cannabis patients typically have access to. Instead, they will be able to study cannabis products that patients use in daily life, such as vapes and various edible products.
This shift in access will now allow researchers to undertake the gold standard of research approaches: the randomized controlled trial.
Randomized controlled trials will help researchers like my colleagues determine how effective cannabis is in treating people with complex medical needs. This includes patients who experience nausea and pain while undergoing cancer treatments, multiple sclerosis patients with severe muscle spasm and stiffness, and chronic pain patients who strive to find relief without using opioids.
Might rescheduling send mixed signals?
Rescheduling may lead people to believe that cannabis is safe for all people to consume.
However, a growing body of research points to possible adverse effects from cannabis use, particularly in vulnerable groups, such as people who are pregnant, adolescents, people with preexisting mental health conditions such as schizophrenia or psychosis, and those with cardiac issues.
Cannabis can also lead to adverse drug interactions. Therefore, medical patients should use it with discretion and under the guidance of a healthcare professional.
For most medical cannabis patients, THC doses should start low and gradually be increased.
Rescheduling will be a big step toward helping researchers build a greatly needed solid body of evidence around both the benefits and potential harms of cannabis. But rescheduling should not be interpreted as a signal that cannabis is harmless.
Carey S. Cadieux, Associate Professor of Nursing, Binghamton University, State University of New York
This article is republished from The Conversation under a Creative Commons license. Read the original article.
Our Lifestyle section on STM Daily News is a hub of inspiration and practical information, offering a range of articles that touch on various aspects of daily life. From tips on family finances to guides for maintaining health and wellness, we strive to empower our readers with knowledge and resources to enhance their lifestyles. Whether you’re seeking outdoor activity ideas, fashion trends, or travel recommendations, our lifestyle section has got you covered. Visit us today at https://stmdailynews.com/category/lifestyle/ and embark on a journey of discovery and self-improvement.
