FDA Approves Roflumilast Foam for Scalp, Body Psoriasis
The foam formulation of the phosphodiesterase-4 (PDE4) inhibitor roflumilast has been approved by the US Food and Drug Administration (FDA) for treating plaque psoriasis of the scalp and body in adults and adolescents aged 12 years and older, according to an announcement from the manufacturer Arcutis Biotherapeutics.
The 0.3% foam formulation of roflumilast (Zoryve) was previously approved for the treatment of seborrheic dermatitis in adults and children aged 9 years and older. The company has since then filed a supplemental New Drug Application with the FDA in September 2024.
A 0.3% cream version is approved as a topical treatment for plaque psoriasis in adults and children aged 6 years and older. And the 0.15% cream formulation of roflumilast is approved for treatment of mild-to-moderate atopic dermatitis for the same population.
Approval is based on data from phase 2b and 3 studies. In the pivotal phase 3 ARRECTOR study recently published in JAMA Dermatology , 432 patients with scalp and body psoriasis aged 12 years and older were randomized to once-daily application of 0.3% roflumilast foam or a vehicle for 8 weeks. Medscape also reported the findings.
Significantly more patients in the roflumilast group vs the vehicle group achieved the primary endpoints of Scalp-Investigator Global Assessment (S-IGA) and Body-IGA (B-IGA) success — defined as clear or almost clear — plus two or more grades of improvement from baseline after 8 weeks of treatment (66.4% vs 27.8% for S-IGA; 45.5% vs 20.1% for B-IGA; P < .001 for both).
In addition, significantly more patients who received roflumilast achieved a clinically significant reduction of itch (defined as a change of ≥ 4 points from baseline on the Scalp Itch-Numeric Rating Scale) compared with those on the vehicle after 8 weeks (65.3% vs 30.3%). Significantly more roflumilast-treated patients with baseline scalp itch also showed significant improvement compared with placebo patients after 2 weeks and 4 weeks of treatment (25.2% vs 8.0%; 46.2% vs 16.8%, respectively; P < .001 for all). Body itch scores also improved significantly in the roflumilast patients compared to those in the vehicle group.
Rates of adverse events were similar and low in both treatment and placebo groups, as were treatment-emergent adverse events and rates of discontinuation because of adverse events, the researchers noted. The most common adverse events reported among patients treated with 0.3% roflumilast foam were headache (1.1%), nausea (1.3%), and nasopharyngitis (1.5%), according to the company's press release. It is contraindicated in patients with moderate-to-severe liver impairment (Child-Pugh B or C).
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Wall Street Journal
24 minutes ago
- Wall Street Journal
Stocks to Watch Monday: Cleveland-Cliffs, Stellantis, Moderna
↗️ Cleveland-Cliffs (CLF), Steel Dynamics (STLD), Nucor (NUE): Shares of U.S. steelmakers jumped premarket after President Trump, speaking at a rally in Pittsburgh on Friday, said he would double tariffs on and steel and aluminum to 50%. ️↘️ Stellantis (STLA): Higher tariffs on imported metal could raise input prices for carmakers with U.S. factories. Stellantis, whose brands include Chrysler, Jeep and Ram, fell premarket. ↗️ Moderna (MRNA): The drugmaker said the FDA had approved a new Covid-19 vaccine for use by people aged 65 or above.
Yahoo
26 minutes ago
- Yahoo
I did 20 military presses every day for a week — here's what happened to my shoulders
When you buy through links on our articles, Future and its syndication partners may earn a commission. I was recently cleared for exercise after having a baby, so I've been very eager to dust off my favorite dumbbells and get back to work. Despite my enthusiasm, I knew I'd have to rebuild my deep core strength first before attempting most of my pre-pregnancy routine. However, I did feel strong enough to incorporate some upper-body exercises into my postpartum program. I was doing military presses consistently both before and during my pregnancy, so I decided to kickstart my return by doing 20 military presses every day for a full week. While this felt like a doable challenge for me, you should always check in with your medical team before trying a new workout, especially if you're postpartum. Meeting with a certified personal trainer is also a good idea to ensure you're moving correctly. The military press, also called an overhead press, is a compound exercise that targets multiple muscles in the shoulder. This move will work the anterior, lateral, and posterior deltoids along with your triceps, serratus anterior, and rotator cuff muscles. Military presses also require core engagement. Your transverse abdominis and internal obliques keep your torso stable and your spine neutrally aligned as you press the weight overhead. You'll need a pair of dumbbells, a barbell, or a curl bar for this exercise. If you have any lower back issues, you may also want an adjustable weight bench so you can sit while performing the movement. Stand with your feet hip-width apart, holding a dumbbell in each hand. Bring the dumbbells to your shoulders with your knuckles facing behind you. Engage your core and maintain neutral spine alignment. Press the dumbbells towards the ceiling. Slowly lower the dumbbells back to your shoulders. Continue for the desired number of reps. If you're using a barbell or curl bar, align the bar with your sternum, with your hands placed slightly wider than shoulder width apart. Engage your core and press the bar overhead. Return to the starting position with control. Since I was returning to exercise after a long absence, I split 20 reps into two sets of 10. Here's what I found after my week-long experiment. Pregnancy really does a number on your core, and I've noticed the lack of strength and stability in my abs even during the simplest of moves. Knowing that I was dealing with some serious core strength deficits, I decided to perform the exercise seated with back support for the first few days. This was the right choice, as even seated, I could feel the muscles in my back trying to overcompensate for my weak abs. Dropping the dumbbell weight alleviated this problem, and the exercise still challenged my shoulder muscles. Keep this in mind if you've got lower back issues or compromised abdominal muscles. Doing the exercise seated takes a lot of the core work out of the equation, but sometimes that's necessary to ensure proper form and prevent injury. Even though I was seated, I still made sure to engage my abdominals throughout the movement. By the time I got to the fifth day of the week, I felt like my core muscles were conditioned enough to try the military presses standing. It was much easier to keep my spine aligned without letting the low back arch. I finished out the week standing, which was more taxing for my core, but in a positive way. I was starting to see the benefits from military presses combined with my postpartum core routine. Military presses are primarily a shoulder exercise, but they're great for building abdominal stability too. My fifth day of military presses also came with a bump in dumbbell weight. Before pregnancy, I was doing military presses with 20 pounds regularly, so I decided to jump back in a bit lighter — 15 pounds. The first few days were harder than I expected, but I started to find my groove by day three. By day four, I barreled through all 20 reps without stopping. I knew that meant I was ready to up the ante, so on day five, I grabbed my 20-pound weights. I was able to increase my dumbbell weight pretty quickly because my body was used to the movement. If you're trying military presses for the first time, be wary of increasing your weight too quickly. Doing so could result in injury. Since the dumbbells were starting to feel easy, I swapped them for a curl bar on the last day of the week. Curl bars look similar to a barbell but are much shorter and lighter, making them accessible to almost anyone. I selected a 35-pound curl bar, which wasn't as heavy as the dumbbells I'd been lifting. The weight displacement on a curl bar is much different than dumbbells, though, and that threw me off a bit. I even developed some slight shoulder pain on the last few reps, and could feel my abdominals working hard. I had to rest before I got to the end of my sets. Doing military presses with different pieces of equipment, like curl bars or kettlebells, could add some much-needed variety to the movement. I'm a personal trainer — here's 3 hip-opening exercises to reduce stiffness and boost lower-body mobility This routine is designed to improve your lower body's range of motion, increase blood flow, and enhance joint mobility Personal trainer shares a five-move mobility routine to unstick tight hips and shoulders using your bodyweight.
Forbes
29 minutes ago
- Forbes
Northern Lights Alert: 13 States May See Aurora On Monday And Tuesday
Wisconsin's night sky is glowing with the Northern Lights, as a geomagnetic storm is bringing ... More vibrant pink and green colors. (Photo by Ross Harried/NurPhoto via Getty Images) The Northern Lights may be visible from 13 U.S. states on Monday, June 2 through Tuesday, June 3, 2025, after a G1 geomagnetic storm was forecast by the National Oceanic and Atmospheric Administration. It comes in the wake of an 'extreme' G5 geomagnetic storm last weekend that saw aurora borealis seen from as far south as California. As Earth approaches the solstice on June 21, the U.S. is currently one of the best places to see the Northern Lights. The agency's three-day forecast has a geomagnetic storm, measured at a value of G1 on a scale of G1 to G5, potentially occurring on Monday night through Tuesday morning in North America. NOAA's aurora viewlines have potential aurora displays that are possible in northern U.S. states and Canada. A total of 13 U.S. states have a chance of seeing the aurora on the northern horizon, with those on the U.S.-Canada border having a higher chance. According to NOAA, this display may be seen from Washington, northern Idaho, Montana, northeast Wyoming, North Dakota, South Dakota, Minnesota, Wisconsin, Michigan, New York, Vermont, New Hampshire and Maine. Regions closest to the border with Canada will have the highest possibility of seeing the aurora. NOAA's forecast for the aurora viewline on Monday, June 2, 2025. According to NOAA's forecast, the Kp index — which provides a rough guide to the intensity of aurora displays — may reach 5, seeing the auroral oval stretch farther south. Kp 5 equates to a G1-class geomagnetic storm. For a Kp in the range of 3 to 5, 'The aurora will move further from the poles, it will become brighter, and there will be more auroral activity (motion and formations)," according to NOAA. "If you are in the right place, these aurora can be quite pleasing to look at.' The geomagnetic storm on May 10, 2024, which saw aurora as far south as Florida, was rated as G5 and had Kp 9 intensity. It was the most powerful since 2003. Although it's forecast for Monday night through Tuesday morning in North America, exactly when and where aurora becomes visible this week will be down not to predictions but data coming in from NASA's DSCOVR and ACE satellites. Orbiting the sun from around a million miles from Earth, they give a roughly 30-minute warning of aurora displays after measuring the solar wind's speed and magnetic intensity. Check NOAA's 30-minute forecast or use the Glendale App for up-to-the-minute forecasts. People visit St Mary's lighthouse to see the aurora borealis, commonly known as the northern lights, ... More on May 10, 2024 in Whitley Bay, England. (Photo by) If your smartphone has a 'Night Mode' feature, that should be good enough to get a more than impressive souvenir shot of the aurora. It likely means a long exposure of between five and 10 seconds, which will look much better if you do three things: The Northern Lights are caused by the solar wind, a stream of charged particles from the sun interacting with Earth's magnetic field. Although the magnetic field deflects much of it, some charged particles accelerate along the magnetic field lines toward the polar regions, where they collide with oxygen and nitrogen atoms, exciting them and causing them to release energy as light. The possibility of displays of the aurora borealis at more southerly latitudes comes from a spike in solar activity, which is currently at a 23-year high due to the current solar maximum period. Geomagnetic storms and aurora are expected to continue through 2025 and 2026. Wishing you clear skies and wide eyes.
