New Prescription Topical for Common Skin Condition

(BPT) - Beyond the appearance and irritation of physical symptoms, seborrheic dermatitis is associated with a decrease in quality of life and may affect emotional well-being, self-esteem, and day-to-day life, like the ability to sleep or do a job.

There has not been a topical drug approved with a new mechanism of action for seborrheic dermatitis in over two decades. Topical treatments are commonly used for seborrheic dermatitis but can come with limitations on how long they can be used in certain areas, and hair-bearing areas make applying topicals like creams, gels, and ointments difficult. These often cause individuals living with seborrheic dermatitis to have complicated treatment regimens and application routines. In fact, according to a national survey of 300 people living with seborrheic dermatitis, many use on average approximately six different treatments each week including prescription, over the counter, and alternative options.

ZORYVE topical foam is approved for the treatment of seborrheic dermatitis in individuals 9 years of age and older. An effective, well-tolerated, once-daily, steroid-free foam, ZORYVE is for use on all affected areas of the body, including hair-bearing areas, with no limitations on duration of use.

ZORYVE foam effectively treats seborrheic dermatitis, including signs and symptoms like redness, flaking, and itching. ZORYVE foam was studied in clinical trials of 683 people with seborrheic dermatitis, including 458 people who used ZORYVE foam and 225 people who used a vehicle (a foam without the active drug). With ZORYVE, 77% had Clear or Almost Clear skin at 8 weeks compared to 53% who used vehicle. ZORYVE foam provided itch relief, and itching is one of the most burdensome symptoms of seborrheic dermatitis. In one of the trials, 63% of 206 people had significant itch relief with ZORYVE at Week 8 versus 41% of 98 people using vehicle.

The most common side effects of ZORYVE include common cold, nausea, and headache.

ZORYVE foam is the first topical drug with a new mechanism of action for seborrheic dermatitis approved in over two decades. It's bringing meaningful innovation to simplify disease management.

Approved Use

ZORYVE foam is a prescription medicine used on the skin (topical) to treat seborrheic dermatitis in adults and children 9 years of age and older.

It is not known if ZORYVE foam is safe and effective in children under 9 years of age.

IMPORTANT SAFETY INFORMATION

ZORYVE is for use on the skin (topical only). Do not use ZORYVE in or on your eyes, mouth, or vagina. Do not use ZORYVE if you have certain liver problems.

Before using ZORYVE, tell your healthcare provider about all of your medical conditions, including if you:

• have liver problems.
• are pregnant or plan to become pregnant. It is not known if ZORYVE will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if ZORYVE passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with ZORYVE. Breastfeeding women using ZORYVE should use it on the smallest area of the skin and for the shortest time needed. Do not apply it directly to the nipple or areola to avoid contact with your baby. Avoid direct skin contact of treated areas with your baby if ZORYVE is applied to your chest.

Tell your healthcare provider about the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What should I avoid while using ZORYVE?

ZORYVE is flammable. Avoid fire, flame, and smoking when applying and right after you apply it.

The most common side effects of ZORYVE include:

These are not all of the possible side effects of ZORYVE. Call your healthcare provider for medical advice about side effects. You are encouraged to report side effects to FDA at 1-800-FDA-1088.

Please see Patient Information for ZORYVE.

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US-CRP-154-00009 05/2024