Your source for the latest industry trends and drug information news.
Volume 6 | Issue 16
August 15, 2024
Contributors:
Chief Authors: Rebecca Waite, PharmD
Contributing Authors: Salome Mawi, PharmD/MBA Candidate and Xintian Wu, PharmD/MBA Candidate
On July 9, 2024, the U.S. Food and Drug Administration (FDA) approved ZORYVE® (roflumilast) 0.15% cream for the treatment of mild to moderate atopic dermatitis in patients 6 years and older. Atopic dermatitis, the most common form of eczema, affects millions of adults and children in the United States. This chronic, relapsing condition presents as an intensely itchy, red rash that can occur anywhere on the body. Other topical therapies are frequently prescribed but may have limitations on duration of use or side effects requiring careful management. Developed by Arcutis Biotherapeutics, Inc., ZORYVE® is a steroid-free phosphodiesterase 4 (PDE4) inhibitor that reduces the inflammatory process involved in atopic dermatitis. It is applied once daily and, unlike steroids, can be used long-term on any part of the body to reduce itching and clear the rash. The cream is available by prescription only.
In clinical trials, twice as many patients experienced a reduction in itching and clearer skin compared to those who did not receive ZORYVE®. The most common side effects associated with ZORYVE® cream include headache, nausea, application site pain, diarrhea and vomiting. The cream is contraindicated in patients with moderate to severe liver impairment.
Prior to its indication for atopic dermatitis, ZORYVE® was approved in a higher strength to treat other skin conditions. ZORYVE® 0.3% cream is approved for plaque psoriasis, and ZORYVE® 0.3% foam is indicated to treat seborrheic dermatitis.
A single lot of Healthy Living Migraine Relief, an over the counter (OTC) medication used to treat headaches, was recalled on July 18, 2024, for lacking pertinent label information. The tablets, which contain acetaminophen 250mg, aspirin 250mg and caffeine 65mg, can be purchased through Amazon. While the medication is called “Migraine Relief”, it is indicated for temporary relief of minor aches and pains due to headache, cold, arthritis, muscle aches, toothache, premenstrual and menstrual cramps. This product was voluntarily recalled by the manufacturer, Aurobindo Pharma USA, Inc., due to the product being shipped in a bottle that was unlabeled. Medications distributed in unlabeled bottles create the risk of improper use and severe adverse effects. For example, customers may not know if they’re taking the correct medication, how much of the medication they should take, the dosage frequency, active ingredients for allergy purposes and any common side effects or interactions associated with the ingredients. Concerning this product specifically, customers would not be warned to avoid use of acetaminophen-containing products in combination with alcohol, as this poses the risk of irreversible liver damage. Consumers who have purchased the impacted product should receive notification of the recall with instructions for returning the product. Consumers should contact their health care provider if any problems have arisen after taking it and any adverse effects should be reported to the FDA’s MedWatch Adverse Event Reporting program.
On August 2, 2024, the U.S. FDA approved Tecelra® (afamitresgene autoleucel) for the treatment of advanced synovial sarcoma. Synovial sarcoma is a rare form of cancer in which a tumor develops in the soft tissues, most commonly in the extremities and often near the joints. Tecelra® is the first gene therapy approved for the treatment of a solid tumor. It is indicated for adults with specific forms of synovial sarcoma who have not responded to other treatments. It uses the patient’s own immune cells to specifically target synovial sarcoma tumor cells. Prior to trying Tecelra®, patients must undergo diagnostic and genetic testing to determine if they are candidates for the therapy. Tecelra® is administered as a single, intravenous dose. The safety and efficacy of Tecelra® was established in a clinical trial that included 44 patients with inoperable metastatic synovial sarcoma who had previously received chemotherapy. Patients had an overall response rate of 43% with a median response lasting six months. After receiving this dose, patients must be monitored for at least 7 days in a healthcare facility due to the potential for severe complications which may be life threatening. The most common side effects associated with Tecelra® include nausea, vomiting, fatigue, infection, constipation, fever, pain, difficulty breathing, reduced appetite, diarrhea, low blood pressure, rapid heart rate, swelling and reduced blood cell counts.
New Drug: EPYSQLI® (eculizumab-aagh)
Intravenous injection approved as a biosimilar to Soliris® for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce the breakdown of red blood cells, and for patients with atypical hemolytic uremic syndrome (aHUS). Both PNH and aHUS are rare blood disorders that cause destruction of red blood cells, blood clots and kidney disease.
Roxybond™ (oxycodone)
Indication: Management of pain severe enough to require an opioid analgesic.
Dosage Form/Strength: 15mg abuse-deterrent immediate-release tablets
Average Wholesale Price (AWP): Generic = $2,072 | Brand = $2,488
