Your source for the latest industry trends and drug information news.
Volume 4 | Issue 16
August 15, 2022
Contributors:
Chief Authors: Rebecca Waite, PharmD, Bonnie Broczkowski, PharmD & Colleen Peehler, PharmD
Contributing Authors: Ali Zahid, PharmD Candidate; Yi (Eve) Zheng, PharmD/MBA Candidate
On July 29, 2022, the U.S. Food and Drug Administration (FDA) approved Zoryve® (roflumilast) 0.3% cream for the treatment of plaque psoriasis, an autoimmune disease affecting a patient’s skin. Plaque psoriasis is a form of psoriasis that presents as inflamed, scaly patches, and sufferers often experience pain and irritation related to these patches. Psoriasis affects 9 million patients in the United States, and 90% of these individuals experience the patches associated with plaque psoriasis. Zoryve® is indicated for daily topical treatment of plaque psoriasis in patients 12 years and older. It has shown to be efficacious in providing rapid clearance of psoriasis patches and in reducing itchiness. It is the first and only phosphodiesterase-4 (PDE4) inhibitor approved for this treatment and provides patients with a new steroid-free treatment option. PDE4 inhibitors work to lessen a patient’s immune response and reduce flare-ups. Unlike other topical products, it is approved for use on all areas of the body, allowing patients to streamline their therapy to just one product for all affected areas. In two different clinical trials, DERMIS-1 and DERMIS-2, the Intertriginous IGA Success Scale and Psoriasis Ares Severity Index were utilized to determine efficacy. Zoryve® improved severity of itch as early as week 2. Over 65% of patients achieved improvements by week 8 in both trials. Of 239 patients who continued treatment long-term, 45% continued to be evaluated as “clear” or “almost clear” at week 52. Zoryve® was very well-tolerated with minimal adverse reactions making this an appealing option for patients with the condition who have not had success with prior therapies.
On July 26, 2022, the FDA announced that Vi-Jon, LLC voluntarily recalled all lots of Magnesium Citrate Saline Laxative Oral Solution due to microbial presence of Gluconacetobacter liquefaciens. The recall includes every lot of lemon, grape and cherry flavor solution within their expiration date. These products were distributed by numerous wholesale and retail outlets nationwide including CVS, Walgreens, Rite Aid and Equate. The use of these contaminated products puts immunocompromised patients at an increased risk for invasive, life-threatening infections caused by this microbe. Vi-Jon, LLC is notifying its customers about the recall. Consumers who have the recalled products should stop using them immediately and return them to where they were purchased. Adverse reactions relating to the recall should be reported to the FDA’s MedWatch Adverse Event Reporting Program. To date, Vi-Jon, LLC is aware of three reports of serious adverse reactions that may be related to this recall.
On July 29, 2022, the FDA released an update on its response to the monkeypox outbreak in the United States. The update provided insight into diagnostics, vaccines and therapeutics. The FDA also launched a webpage dedicated to providing updates about the disease. Monkeypox is part of the family of viruses that causes smallpox and is generally not fatal. It can be resolved without treatment, but it is known to cause severe pain and lesions sometimes requiring hospital admission.
The FDA is working with commercial laboratories and manufacturers to make monkeypox tests more readily available to at-risk individuals. There is currently only one FDA-approved test available. The test is most accurate when samples are taken directly from a lesion. Along with pushing for more accessible testing, the FDA is working to increase availability of the monkeypox vaccine. The JYNNEOS Vaccine was approved by the FDA in 2019 for the prevention of smallpox and monkeypox in adults 18 years and older. In recent weeks, it has been available primarily to patients determined to be at high risk of monkeypox infection. On July 26, the FDA approved a supplement to the vaccine’s biologics license which increases the capabilities of the manufacturer’s facility to meet the increasing need. Currently, there is no FDA-approved or authorized medication for the treatment of monkeypox. TPOXX (tecovirimat) is being made available for use as a treatment under the “compassionate use” program called Expanded Access, but this medication is still being studied for safety and efficacy in humans.
New FDA Approval: Zoryve™(roflumilast) topical cream
Topical cream approved for the treatment of plaque psoriasis in adult and pediatric patients 12 years and older. [7/29/2022 – ARCUTIS BIOTHERAPEUTICS, INC.]
Zinc Sulfate Injection
Indication: Zinc deficiency treatment via intravenous administration
Dosage Form/Strength: 30 mg/10 mL solution, 25 mg/5 mL solution
Average Wholesale Price (AWP): Generic = $192.70 | Brand = $404.10
