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Pulse Newsletter

Your source for the latest industry trends and drug information news.

Volume 6 | Issue 5
March 1, 2024

Chief Authors: Rebecca Waite, PharmD
Contributing Authors: Gabrielle Graca, PharmD/MBA Candidate and Salome Mawi, PharmD/MBA Candidate

Clinical Pharmacy Update

Novel Treatment for Severe Frostbite

On February 14, 2024, the U.S. Food and Drug Administration (FDA) approved Aurlumyn™ (iloprost) injection for the treatment of severe frostbite in adults. Severe frostbite is a serious condition caused by exposure to freezing temperatures in which the skin and underlying tissue are frozen and blood flow to the area is stopped. The most common areas affected are the fingers, toes, nose and ears. In severe cases, it can require amputation of the damaged tissue. Aurlumyn™ is the first medication available to treat severe frostbite and reduce the risk of amputation of fingers and toes. Iloprost, the active ingredient in Aurlumyn™, is a vasodilator that opens blood vessels and prevents clotting that was first approved to treat pulmonary arterial hypertension in 2004. Treatment with this medication is believed to reduce the risk of amputation from frostbite by restoring blood flow, leading to less tissue damage. In a clinical trial of individuals with severe frostbite, groups treated with Aurlumyn™ had a significantly lower percentage of patients who required amputation compared to groups not treated with the medication. Some common side effects of Aurlumyn™ include headache, flushing, fast heart rate and low blood pressure. Aurlumyn™ received Priority Review and Orphan Drug designations from the FDA. 

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Drug Safety

Recall of TING Antifungal Spray

On February 1, 2024, Insight Pharmaceuticals announced a voluntary recall of two lots of Ting® 1% Tolnaftate Athlete’s Foot Spray Antifungal Spray Liquid due to the presence of benzene. Benzene is classified as a human carcinogen. It is not an ingredient of the product, but it is a component of the propellant used in the spray can. The product is packaged in blue and white aerosol cans. The affected lots are 0H50545 and 1G50645 with expiration dates of 7/24 and 6/25, respectively. Insight has notified retailers to remove recalled products from shelves, and consumers who purchased recalled lots are advised to stop using the product immediately. A full refund can be requested by contacting Insight Pharmaceuticals and submitting a picture of the bottom of the can which proves it is one of the recalled products. There have been no adverse events related to this recall to date, but patients should contact their health care provider if any problems arise from use of this product. Adverse effects should also be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program

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From the Pharmaceutical Industry

Effect of Long-Acting Injectable Antipsychotics on Schizophrenia Hospital Readmission Rates

On January 17, 2024, the Journal of Clinical Psychopharmacology published a study showing the efficacy of long-acting injectable (LAI) antipsychotics in reducing rehospitalization of patients with schizophrenia compared to oral medications. Schizophrenia is a chronic psychiatric disorder that may present with delusions, hallucinations and/or disorganized thinking. There is no cure for schizophrenia, and worsening of these symptoms may lead to hospitalizations, thereby reducing patient quality of life and increasing health care costs. This study focused on readmission rates for patients treated with oral antipsychotic medications versus those utilizing long-acting injectable options. The 30-day readmission rate for those taking oral antipsychotics was 8.3%, and the rate for those treated with LAI antipsychotics was 1.9%. Based on these results, LAI antipsychotic medications had a significant impact on reducing hospital readmission rates in patients with schizophrenia compared to those on oral treatment regimens. Patient medication adherence may be a contributing factor in these results as oral antipsychotic medications are taken daily, making it possible to miss some doses that would lead to suboptimal effectiveness. LAI antipsychotics help patients maintain control of their symptoms by eliminating the possibility of missed doses between injections. Depending on the medication selected, the frequency of administration of LAI antipsychotics can range from every two weeks to every six months. 

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FDA Approvals

New FDA Approvals

New Dosage Form: Eohilia™ (budesonide) 

Oral suspension approved for the treatment of adult and pediatric patients 11 years and older with eosinophilic esophagitis (EoE), a chronic disease characterized by inflammation and irritation of the esophagus [02/09/2024 – TAKEDA]

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New Generics

New Generics Entering the Marketplace

Pradaxa® (dabigatran) 

Indication: Prevention of blood clots, including deep vein thrombosis and pulmonary embolism, following hip replacement surgery

Dosage Form/Strength: 110mg capsule

Average Wholesale Price (AWP): Generic = $226 | Brand = $238

BromSite® (bromfenac) eye drops

Indication: Treatment of postoperative inflammation and pain following cataract surgery

Dosage Form/Strength: 0.075% ophthalmic solution

Average Wholesale Price (AWP): Generic = $292 | Brand = $324