New Drugs for Advanced Melanoma, ADHD, Narcolepsy, Pain, Prostate Cancer; Telehealth Lawsuit; Cell-Based Therapies; Tips for Bone Health
New OTC Pain Treatment Approved: Acetaminophen and NSAID in Single Tablet
The FDA approved Kenvue’s Tylenol with Naproxen tablets (acetaminophen 325 mg and naproxen sodium 110 mg), the first fixed-dose combination tablet of these medications for age 12 and up. One tablet is taken every 12 hours for temporary relief of minor aches and pains due to headache, backache, muscular aches, toothache, menstrual cramps, and minor pain of arthritis.
At 110 mg, the naproxen sodium contained in this tablet is half the normal dose (220 mg) that is in a regular naproxen sodium tablet like Aleve. The acetaminophen strength is the same as in a regular strength Tylenol tablet. There is some confusion with the Kenvue communication because Kenvue’s press release says the drug has 220 mg of naproxen but the image and all of the FDA’s communications only refer to 110 mg of naproxen.
FDA Press Release: FDA Approves-first-nonprescription-fixed-dose-combination-acetaminophen-and-naproxen-sodium-12-hour
New Advanced Melanoma Treatment Tudriqev
Replimune’s Tudriqev (vusolimogene oderparepvec-wtpg) was approved to treat advanced melanoma in patients whose tumors are growing despite prior treatment. Tudriqev is to be used in combination with Bristol Myers Squibb’s immunotherapy, Opdivo (Nivolumab). Tudriqev is an “Oncolytic virus therapy” that uses a herpes simplex virus type 1 (HSV-1) that is engineered to selectively target and destroy cancer cells.
Tudriqev is injected directly into tumors once every two weeks for eight consecutive doses, with the dosage amount determined by the size of the tumor. Once inside a tumor, the virus replicates and breaks cancer cells apart, while simultaneously triggering the body’s immune system to recognize and attack the cancer.
FDA Press Release: FDA approves-new-engineered-viral-immunotherapy-patients-treatment-resistant-advanced-melanoma
Fierce Biotech: Replimune's Twice-Rejected Melanoma Drug Prevails
Keck Medicine: Cancer-fighting Herpes Virus Shown to be an Effective Treatment for Some Advanced Melanoma
Amtagvi, approved in 2024, (see section below on cell therapies) is another treatment option for advanced melanoma.
New ADHD Medication Approved
Otsuko’s Simtryo (centanafadine) received FDA approval to treat attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients aged 6 years and older who weigh at least 20 kg (44 pounds). The once-daily extended-release capsule is considered “first in class” because it combines an SSRI (like those used in the antidepressant Prozac) and NDRI stimulant (drug blocking the reuptake of norepinephrine and dopamine, such as used in ADHD medication Ritalin.) It is classified as a norepinephrine, dopamine, serotonin reuptake inhibitor (NDSRI) and works “by blocking the reuptake of three neurotransmitters at once rather than flooding the synapse the way amphetamine-based drugs do.”
Simtriyo will be commercially available after the U.S. Drug Enforcement Administration completes its scheduling process. The drug is likely to be assigned a “Schedule II” drug because of the stimulant ingredient. Stimulants Ritalin, Adderall, and Concerta are Schedule II because of potential for abuse or addiction.
Otsuko Press Release
Read more about NDRI (Norepinephrine-dopamine reuptake inhibitors) for ADHD:
Neurolaunch: NDRI Drug List
New Drug for Narcolepsy Sleep Disorder
Takeda’s Orzeyful (oveporexton) was approved for the treatment of narcolepsy type 1 in adults. Narcolepsy type 1 is a rare, lifelong neuropsychiatric sleep disorder affecting an estimated 1 in 2,000 people in the United States. It is caused by the loss of brain cells that produce orexin, a chemical messenger that regulates wakefulness, sleep, and muscle tone. The tablets, taken twice daily, work by targeting the loss of orexin signaling. This drug will be commercially available after the U.S. Drug Enforcement Administration completes its scheduling process.
Other narcolepsy drugs include Provigil (Modafinil) and Nuvigil (Armodafinil), which are classified as DEA schedule IV; Wakix is a “daytime sleepiness” narcolepsy drug and is not on a controlled drug list.
FDA Press Release: https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-treat-full-range-narcolepsy-type-1-symptoms
Pluvicto Prostate Cancer Treatment Receives Expanded Approval
Novartis’ Pluvicto received expanded approval for all stages of PSMA-positive metastatic prostate cancer, which Novartis says “nearly doubles” the pool of patients eligible for the radioligand med. Previously, the treatment was only approved for a later stage known as metastatic castration-resistant prostate cancer. Pluvicto is considered a “radioligand” therapy; it is administered by a radiation oncologist.
Fierce Pharma: Novartis-rlt-pluvicto-leaps-ahead-earlier-manifestation-prostate-cancer
Dana Farber Cancer Institute Explains how radioligand therapy is different than chemotherapy: Five Things-to-know-about-radioligand-therapy/
FTC sues Hims & Hers Telehealth for False Billing and Privacy Breaches
After receiving thousands of complaints from consumers, the Federal Trade Commission (FTC) and its state and local partners have filed a complaint against Hims & Hers telehealth company for locking unknowing consumers into recurring subscriptions, making it difficult to cancel, and for disclosing private health information to third parties (Meta, Google, and other Big Tech) while promising to keep the information private. Also, the platform is accused of immediately charging consumers for prescriptions after they submit an “intake form” instead of waiting until after a healthcare consultation.
Forbes says that the lawsuit could become one of the most significant consumer-protection cases in the telehealth space and could decide how online healthcare companies design patient intake forms, subscription billing, cancellation flows and advertising technology going forward. Hims & Hers called the claims “baseless” in a post on X and vowed to fight them.
FTC Press Release: FTC States-act-against-hims-hers-deceptive-unlawful-privacy-practices
Other Legal Troubles for Hims & Hers:
Last year, the FDA sent warning letters to Hims & Hers for making misleading claims on their website. Separately, FDA issued a press release warning consumers about topical finasteride sold on various telehealth sites, including Hims and Hers. The company has also been warned for its misleading advertising.
Journavx Increasingly Used for Chronic Pain
A study appearing in Epic Research suggests that one-third of Journavx (suzetrigine) prescriptions were written for a diagnosis of chronic pain, which is an off-label use. Journavx (Suzetrigine) was approved in January 2025 to treat moderate to severe acute pain, such as pain resulting from injury or surgery. Unlike opioids, Journavx blocks pain signals in the peripheral nervous system, not in the brain. Results from clinical trials suggest that Journavx is a mild pain reliever, at best, for acute or chronic pain.
Pain News Network: Non-opioid-journavx-is-being-prescribed-off-label-for-chronic-pain
Medication Tips: Preparing for Cell-Based Therapy
If you have been diagnosed with a serious disease and are considering getting a gene or cell-based therapy, you may wonder how the treatment compares to others you may have had. This kind of therapy takes days or weeks to prepare before you can take it, since the drug is custom made for you. Also, the side effects during the therapy can be grueling, often involving a hospital stay, chemotherapy or other adjunct treatments. The good news is that the therapy is often a one-and-done type of event.
Dr. Muhammad Tariq, from the University of Florida’s Division of Hematology & Oncology, explains what patients and caregivers should understand as they consider “living drug” treatments such as CAR-T for blood cancers or tumor-infiltrating lymphocyte therapy for melanoma.
Cure Today: “What-patients-should-know-about-preparing-for-cell-therapy”
Cure Today reports that when an FDA advisory committee was considering whether to recommend approving the virus-based oncology therapy for advanced melanoma (Tudriqev), it kept going back to compare it with the cell based therapy Amtagvi. Read that account, along with a patient testimonial about his experience with Amtagvi.
Cure Today: Fda-advisory-committee-backs-rp1-for-advanced-melanoma
Check here for the list of FDA-approved gene and cell therapies, which include CRISPR (gene editing) treatments, for various cancers, sickle cell anemia (Casgevy), treatments for other genetic diseases like Duchenne’s, and more:
FDA-Approved Cellular and Gene Therapy Products
Related Story on Gene Therapy:
Medication Tips: Protecting Your Bones
Liz, a registered dietician with osteopenia (low bone density) shares some lifestyle changes she made over the course of three years between DEXA scans to improve her bone health. “Bone health is about more than taking calcium and vitamin D supplements.”
Rethinking Preventing Fractures in the Elderly
Here is a related story and perspective that we posted in 2023, but is worth sharing again. Is boosting bone mass through pharmacotherapy (drugs) really the best way to prevent fractures in the elderly? Teppo Järvinen, professor of Orthopaedics and Traumatology at the University of Helsinki, outlines the work he and his colleagues have done that question our current approach to preventing fractures in the elderly. He argues that the focus should be on fall prevention:
Did you miss yesterday’s edition with Drug Safety News? Check it out here:
