FDA Approves Adquey (difamilast 1%) Ointment for the Treatment of Mild-to-Moderate Atopic Dermatitis

Acrotech Biopharma Inc., a bio-pharmaceutical company focused on developing and commercializing innovative propriety medications, in collaboration with Otsuka Pharmaceutical Co., Ltd.,  announced  the U.S. Food and Drug Administration (FDA) approval of  New Drug Application (NDA) for Adquey (difamilast 1%) ointment, for the topical treatment of mild-to-moderate atopic dermatitis (AD) in adults and pediatric patients aged 2 and older.

Adquey is a novel, non-steroidal, topical phosphodiesterase 4 (PDE4) inhibitor. This approval provides a new non-steroidal, topical treatment option for the millions of Americans living with atopic dermatitis. "The approval of Adquey represents a significant milestone in our commitment to advancing dermatology care," said Ashish Anvekar, President of Acrotech Biopharma Inc. "Patients and clinicians have long sought effective, long-term, non-steroidal treatments that can manage both the inflammation and pruritus associated with eczema. We intend to bring this valuable treatment option to the patients in the U.S. as soon as possible."

Clinical Trial Results

FDA approval was supported by multiple studies including pivotal Phase III controlled trials, which demonstrated that a significantly greater proportion of patients treated with Adquey achieved Investigator’s Global Assessment (IGA) success compared to vehicle (placebo) after four weeks of treatment. The safety profile of Adquey AD was consistent across all three trials. The most common adverse reactions (≥1% and greater than vehicle) was nasopharyngitis. Less common (<1%) adverse reactions in subjects treated with Adquey included application site folliculitis, contact dermatitis, application site rash, and molluscum contagiosum.

https://en.wikipedia.org/wiki/Difamilast

FDA Approves Adquey (difamilast 1%) Ointment for the Treatment of Mild-to-Moderate Atopic Dermatitis

FDA Approves Zoryve for Atopic Dermatitis in Young Children

In continuation of my update on Zoryve

The U.S. Food and Drug Administration has approved the supplemental new drug application for Zoryve (roflumilast) cream 0.05 percent for the topical treatment of mild-to-moderate atopic dermatitis in children 2 to 5 years of age.

The once-daily cream can be used anywhere on the body and for any duration. This approval offers an alternative to steroids.

The approval is based on clinical trials that showed Zoryve cream rapidly improved the severity and extent of eczema signs and symptoms, with approximately 40 percent of children achieving a 75 percent improvement from baseline on the Eczema Area and Severity Index. Additionally, more than one-third of participants (35 percent) achieved clinically meaningful improvement in itch intensity in four weeks.

"Young children are particularly vulnerable to the bothersome symptoms of atopic dermatitis, because their immune system and skin barrier are less developed than those of older children and adults," Korey Capozza, founder and executive director at Global Parents of Eczema Research, said in a statement. "This condition doesn't just affect the child's skin -- it can affect the whole family by causing sleep disruption, emotional distress, and social isolation."

Approval of Zoryve was granted to Arcutis Biotherapeutics.

More Information

FDA Approves Zoryve for Atopic Dermatitis in Young Children 

Positive data from rose bengal disodium for psoriasis & atopic dermatitis....

Acid Red 94, (Rose Bengal sodium salt), 3,4,5,6-tetrachloro-2-(2,4,5,7-tetraiodo-6-oxido-3-oxoxanthen-9-yl)benzoate :

Provectus Pharmaceuticals, Inc announced preliminary data for the company’s PH-10 Phase 2 clinical trial for Psoriasis as well as for its Phase 2 clinical trial for Atopic Dermatitis. As per the claim by the company, in its Phase 2 trial of PH-10 (0.001% Rose Bengal) for psoriasis, preliminary data shows that 79% of 29 subjects in the clinical trial demonstrated improvement in the Psoriasis Scoring Index (PSI) during four weeks of daily treatment with PH-10. In addition, 83% of the subjects reported no or only mild pruritus (itching) by week four of the trial, with no significant safety issues noted. The 30^th and final subject will complete final evaluation in early December.

In its Phase 2 trial of PH-10 for atopic dermatitis (“eczema”), preliminary data from the first 18 subjects indicated that 94% of subjects had improvement in the Eczema Area Severity Index (EASI) during four weeks of treatment. Subjects applied PH-10 daily for up to four weeks to skin areas affected by atopic dermatitis, with response observed weekly throughout this treatment phase and for one month after the end of this period. As in the psoriasis study, the treatments were generally well tolerated with no significant safety issues identified. Hope a sigh of relief for those suffering from psoriasis and atopic dermatitis....

Ref : http://www.pvct.com/pressrelease.html?article=20091201