Pulse Newsletter | Volume 8 - Issue 9

FDA Approves Drug to Treat Narcolepsy Type 1 Symptoms in Adults

On August 5, 2026, the U.S. Food and Drug Administration (FDA) approved Orzeyful^® (oveporexton) tablets for the treatment of narcolepsy type 1 in adults. Narcolepsy type 1 is a rare neurological sleep disorder causing excessive daytime sleepiness along with sudden loss of muscle control. Orzeyful^® was granted breakthrough therapy designation and priority review by the FDA. The drug works by targeting a specific receptor of orexin (a chemical in the brain responsible for regulating being awake and alert) associated with narcolepsy type 1. The recommended dose of Orzeyful^® is 1-2mg taken by mouth once upon awakening in the morning, followed by 1-2mg 3-5 hours later. The maximum recommended dose is 4mg per day. Orzeyful^® will be available as a 0.5mg, 1mg and 2mg tablet. Common side effects of Orzeyful^® include insomnia or trouble falling asleep at night, which occurred in about 55-60% of patients, increase in urinary frequency, which occurred in about 50-60% of patients, and increased saliva production.

The safety and efficacy of Orzeyful^® was established based on the results of two 12-week randomized, multicenter, double-blind placebo-controlled phase 3 clinical trials including 196 patients with a diagnosis of narcolepsy type 1. The primary clinical endpoint was the difference between baseline and 12-week assessment of a patient’s results from a maintenance of wakefulness test (MWT), which measures an individual's ability to stay awake in a dark, quiet environment. Patients given Orzeyful^® demonstrated a statistically significant improvement in their MWT. The change from baseline in the patients given Orzeyful^® was between 12.5 to 19 minutes, compared to no improvement in MWT in patients given placebo. Orzeyful^® is not yet available in the U.S. The price of Orzeyful^® is anticipated to be at least $142,000 per year, which is similar to the price of other drugs used to treat narcolepsy, such as Lumryz^™, Xywav^® and Xyrem^®.

FDA Approves mRNA Flu Vaccine Safe and Effective for Adults 50 and Older

On August 5, 2026, the FDA approved mFLUSIVA^® (influenza vaccine, mRNA) for prevention of influenza subtypes A and B in adult patients aged 50 years and older. mFLUSIVA^® is the first flu vaccine in the U.S. to use mRNA technology. mRNA vaccines can be developed more quickly than traditional flu vaccines. Traditional flu vaccines use either live or inactivated virus and can take around 6 months to develop, creating a challenge to accurately predict the annual flu virus strains. Inactivated flu vaccines use eggs to grow flu virus, then inactivate the virus to make the final vaccine. mRNA vaccines are made differently and can be developed in about a month, which may have an advantage when creating an annual flu vaccine. They work by delivering instructions to the body to produce and identify a piece of the flu virus which can then generate an immune response.

The safety and efficacy of mFLUSIVA^® was established in two phase 3 randomized, double-blind clinical trials comparing mFLUSIVA^® to a standard or high dose of inactivated annual flu vaccine. The primary endpoint in the trial was confirmation of influenza illness, as determined by the presence of at least one systemic symptom, such as fever, chills, headache or muscle pain, and at least one respiratory symptom, such as cough, sore throat, wheezing or trouble breathing, beginning at least 14 days after receiving the flu vaccine through the end of flu season. The results of the trials concluded that mFLUSIVA^® was about 27% more effective at preventing the flu compared to a regular inactivated annual flu vaccine with a similar safety profile. mFLUSIVA^® is administered intramuscularly as a single 0.38 milliliter dose. The most common side effects after receiving the vaccine were injection site pain, headache, fatigue, muscle pain and weakness, joint pain, chills and swelling. mFLUSIVA^® is currently available as an option for adults ages 50 and older for this flu season.

FDA Approves New Drug to Treat Attention-Deficit Hyperactivity Disorder (ADHD)

On July 24, 2026, the FDA approved Simtriyo^® (centanafadine) extended-release capsules for the treatment of attention-deficit hyperactivity disorder (ADHD) in adult and pediatric patients 6 years and older and weigh at least 44 pounds. ADHD is a common and chronic neurodevelopmental disorder that develops in childhood and may continue into adulthood. Symptoms include difficulty focusing, impulsivity, and increased moving, fidgeting or restlessness. The recommended starting dose of Simtriyo^® in adult patients is 210mg taken by mouth once a day in the morning. Dose may be increased to a maximum dose of 280mg once daily based on the patient’s clinical response and side effects. Pediatric dosing is based on weight, ranging from 140mg to 280mg daily. The most common side effects of Simtriyo^® are rash, decreased appetite, weight loss, nausea, headache, diarrhea, dry mouth, insomnia and stomach pain. Warnings and precautions of Simtriyo^® include, but are not limited to, risk of raising heart rate and blood pressure, psychiatric adverse reactions and growth suppression. Simtriyo^® should be avoided in patients with serious heart disease. Simtriyo^® contains a boxed warning (the most serious safety warning) in the package labeling for risk of suicidal thoughts or behaviors in pediatric patients, along with risk of abuse and addiction. Pediatric patients should be closely monitored by their doctor as well as their parent or caregiver for any unusual changes in their behavior.

The safety and efficacy of Simtriyo^® was determined in two randomized, double-blind, multicenter, placebo-controlled clinical trials in pediatric patients with ADHD. The primary endpoint was reduction in ADHD symptoms compared to baseline. Patients treated with Simtriyo^® showed a statistically significant reduction in ADHD symptoms compared to placebo. Simtriyo^® is not yet available in the U.S. Pricing is not yet available, but Simtriyo^® is expected to cost around $500 per month.

New FDA Approvals

New Drug: Zenbexus^™ (iberdomide)

Oral capsules approved for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. [8/13/2026 – Bristol-Myers Squibb Co.]

New Generics Entering the Marketplace

Retin-A Micro Gel^® (tretinoin gel microsphere)

Indication: For the treatment of acne vulgaris in adult and pediatric patients 12 years and older.  

Dosage Form/Strength: 0.06% gel

Average Wholesale Price (AWP): Generic = $850/50-gram bottle | Brand = $1,000/50-gram bottle