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Pulse Newsletter

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

Volume 5 | Issue 9
June 1, 2023

Chief Authors: Rebecca Waite, PharmD, Bonnie Broczkowski, PharmD & Colleen Peehler, PharmD
Contributing Authors: Yi (Eve) Zheng, PharmD/MBA Candidate, Gabrielle Graca, PharmD/MBA Candidate

Clinical Pharmacy Update

FDA Approves First Non-Hormonal Drug to Treat Moderate to Severe Hot Flashes Due to Menopause 

On May 12, 2023, the U.S. Food and Drug Administration (FDA) announced the approval of AstellasPharma’s Veozah (fezolinetant) for the treatment of moderate to severe hot flashes related to menopause. Hot flashes, also known as vasomotor symptoms, are episodes of flushing, sweating and chills that can last several minutes. These episodes affect 80% of menopausal women and can impair their quality of life. Symptoms are related to the declining production of hormones estrogen and progesterone during menopause. Hormone replacement therapy (HRT) has been the standard treatment for women experiencing hot flashes, but unfortunately not all women are candidates. Veozah® is not a hormone therapy, thereby offering a safe and effective alternative for menopausal women with a history of blood clots, stroke, liver disease or heart attack who are unable to safely take HRT.

Veozah® is a medication that blocks the neurokinin 3 (NK3) receptor which helps in the regulation of body temperature. It is a once daily oral medication that should be taken at the same time each day, with or without food. The most reported side effects of Veozah® include diarrhea, abdominal pain, back pain and elevated liver enzymes. Veozah® was tested in two randomized, double-blind, placebo-controlled phase 3 clinical trials. Each trial ran for 52 weeks with the average age of participants being 54. In the first 12 weeks of each study, Veozah® showed a significant reduction in frequency of hot flashes from participants’ baseline. The following 40 weeks were utilized to evaluate safety of treatment and duration of effect. The prescribing information for Veozah® includes a warning for liver injury, so patients should receive bloodwork to review liver function prior to treatment. For the first 9 months of treatment, this bloodwork should be repeated every 3 months. Patients are also advised to self-monitor for possible signs and symptoms related to liver damage, such as nausea, vomiting or yellowing of the skin or eyes. Veozah® was granted Priority Review designation by the FDA.

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Drug Safety

Abbott Notifies Customers of Safety Hazards of FreeStyle Libre® Family of Glucose Readers 

On April 3, 2023, Abbott issued a safety warning to users regarding proper battery maintenance for the FreeStyle Libre® Readers, a component of their continuous glucose monitoring (CGM) systems. These CGMs consist of a sensor worn on the back of a patient’s arm that collects real-time glucose levels and a handheld reader device that collects this data from the sensor. Each CGM reader contains a lithium-ion battery. These batteries have the potential for battery leakage, swelling or extreme overheating when used incorrectly. Abbott’s warning was issued to emphasize the proper instructions for storing and charging the FreeStyle Libre®, FreeStyle Libre® 14 day and FreeStyle Libre® 2 Readers to mitigate the risks of battery leakage or fires. Abbott has also outlined the appropriate steps on their FreeStyle battery website. They emphasize the importance of using the Abbott-supplied yellow USB cable and adapter for charging. Abbott has been notifying customers of these safety recommendations via emails and letters since February. At this time, there have been no reported incidents which have led to serious health problems or death, and there are no battery concerns related to the FreeStyle Libre® family of sensors. Abbott is not recalling any devices, but customers are welcome to contact Abbott’s Customer Service if they have questions or require replacement accessories.

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From the Pharmaceutical Industry

FDA Moves to Decentralize Clinical Trials to Increase Ease of Participation 

The FDA has released a draft guidance that provides recommendations regarding the implementation of decentralized clinical trials for drugs, biologic medications and medical devices. Typically, traditional clinical trials require participants to complete some or all testing and appointments in person at predetermined clinical trial sites. This is a huge barrier which results in decreased diversity of participants due to accessibility and scheduling difficulties for certain segments of the population. Decentralized clinical trials would consist of some or all visits taking place in a more convenient location such as the person’s home. This accommodation would encourage participation by a broader range of individuals, including those of varying ages, physical and mobility limitations, socioeconomic situations and underrepresented racial backgrounds. Allowing for more diverse representation would decrease the limitations and biases of trials that are conducted and allow the results to be applied to more patients. The convenience would also help to facilitate research of rare diseases that may cause limited mobility or leave patients homebound. The benefits of decentralized trials have been considered by the FDA for years, and the COVID-19 pandemic accelerated the implementation of these programs. The new draft guidance covers utilization of telehealth, digital technology, transportation of investigational products and design considerations for a decentralized clinical trial. The FDA plans to work with sponsors to implement decentralized elements into clinical trials.

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FDA Approvals

New FDA Approvals

New Dosage Form: Abilify Asimtufii® (aripiprazole)

Extended-release intramuscular injection approved for the treatment of schizophrenia and bipolar 1 maintenance monotherapy in adult patients. Extended-release formulation allows longer-lasting treatment and less frequent administration, injected every 2 months. [04/27/2023 – OTSUKA PHARM]

New Dosage Form: Motpoly XR (lacosamide)

Extended-release oral capsule approved for the treatment of partial-onset seizures in adult and pediatric patients over 110 pounds. [05/04/2023 – AUCTA PHARM]

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New Generics

New Generics Entering the Marketplace

UCERIS® (budesonide)

Indication: Mild to moderate ulcerative colitis of the lower colon and rectum

Dosage Form/Strength: Rectal foam, 2mg/actuation 

Average Wholesale Price (AWP): Generic = $878 | Brand = $975