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Pulse Newsletter

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

Volume 3 | Issue 11
June 1, 2021

Chief Author: Dana Ranallo, PharmD
Contributing Author: James Pufpaff, PharmD/MBA Candidate

Clinical Pharmacy Update

FDA Approves Zynrelef™ for the Management of Postoperative Pain

On May 13, 2021, Heron Therapeutics Inc. announced the U.S. Food and Drug Administration’s (FDA) approval of Zynrelef™ (bupivacaine and meloxicam) extended-release solution to provide adults with postsurgical pain relief for up to 72 hours after total knee replacement, bunion removal or groin hernia repair. Zynrelef™ is applied directly into the soft tissue or area surrounding the joint near the surgical site prior to suturing. Postsurgical pain is typically most severe in the first three days after surgery and opioids are often the drug of choice to manage pain in these patients. Zynrelef™ is a non-opioid, dual-acting medication that consists of bupivacaine, a localized pain reliever used to numb areas of the body, and meloxicam, a nonsteroidal anti-inflammatory drug (NSAID). The combination of the two drugs provides a synergistic effect which results in lower pain intensity for the first 72 hours following surgery and a decreased need for opioids. The elimination or decrease of the need for opioids post-surgery is significant because it reduces the potential for misuse or abuse of these high-risk medications. This approval was granted after Phase 3 studies demonstrated that Zynrelef™ was superior to bupivacaine injection, the current standard of care, in providing sustained postoperative pain relief, with most common adverse reactions being constipation, vomiting and headache. Zynrelef™ is expected to become commercially available by July 2021.

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Drug Safety

Novo Nordisk Issues Voluntary Nationwide Recall of Diabetes Product Samples

On May 7, 2021, Novo Nordisk announced a voluntary recall of 1,468 product samples for Levemir®, Tresiba®, Fiasp®, Novolog® and Xultophy®, all of which are anti-diabetic agents that are used to control blood sugar levels in people with diabetes. The recall was issued after it was found that these product samples were stored at temperatures below storage requirements. Products exposed to temperatures below 32°F may become damaged and lose efficacy, resulting in an incorrect dose upon administration and potentially high or low levels of blood sugar. Signs and symptoms of low blood sugar include feeling shaky, nervous or anxious, sweating, chills and confusion. High blood sugar can result in an increase in thirst and frequency of urination. Testing blood sugar regularly at home as directed by a health care provider is the best way to identify abnormal blood sugar levels. The recall impacts product samples distributed to the consumer level from physicians’ offices but no products that have been dispensed by pharmacies or mail-order services. All physician’s offices that received affected samples have been notified and advised to reach out to patients who may have received those samples. Recalled products can be identified by matching the printed batch or lot number on the product to the recall list provided by Novo Nordisk. As of May 7, 2021, Novo Nordisk has not received any reports of serious adverse events or injuries related to this recall. Adverse reactions or quality problems related to the recall should be made to Novo Nordisk’s Customer Care Center as well as to the FDA’s MedWatch Adverse Event Reporting Program.

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From the Pharmaceutical Industry

Sanofi-GlaxoSmithKline Move Forward with COVID-19 Vaccine

On May 17, 2021, Sanofi and GlaxoSmithKline (GSK) announced interim results of a Phase 2 trial which showed the success of their COVID-19 vaccine candidate in producing a significant immune response against the COVID-19 virus. The vaccine was developed using the same protein-based technology used in Sanofi’s seasonal influenza vaccine in addition to GSK’s adjuvant technology, which is used in vaccines to enhance immune response and create longer lasting immunity. The adjuvanted protein-based vaccine is administered as a 2-dose regimen, with the second dose 21 days after the first. Immunity is achieved 14 days after the second dose. The Phase 2 study, which included 722 participants 18 years and older across the U.S. and Honduras, evaluated efficacy by measuring the levels of antibodies, proteins that elicit an immune response, in the blood stream. Results showed 95-100% seroconversion, or development of antibodies, following second injection in all age groups (18-95 years old). The vaccine also produced antibody levels that were comparable to those generated by natural infection, with higher levels observed in younger adults (18 to 59 years old). Sanofi-GSK observed higher antibody responses in those individuals who had prior infection with COVID-19, suggesting that their vaccine may have value as a potential booster shot regardless of which vaccine was received initially. A global Phase 3 trial is expected to begin within the coming weeks and is targeted to include over 35,000 participants. If the adjuvanted protein-based vaccine proves to be safe and effective, it may be available on the market as early as the fourth quarter of 2021 to help address the ongoing COVID-19 pandemic.

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FDA Approvals

New FDA Drug Approvals

Novel Drug Approval: Empaveli™ (pegcetacoplan)
Subcutaneous infusion approved for the treatment of adult patients with a rare blood disorder, paroxysmal nocturnal hemoglobinuria [5/14/21 – Orphan DrugPriority Review– APELLIS PHARMACEUTICALS INC]

Novel Drug Approval: Rybrevant™ (amivantamab-vmjw)
Intravenous infusion approved for the treatment of adult patients with non-small cell lung cancer [5/21/21 – JANSSEN BIOTECH]

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New Generics

New Generic Medications Entering the Marketplace

Thiola® (tiopronin)
Indication: Prevention of the formation of a certain type of kidney stones
Dosage Form/Strength: 100 MG Tablet
Average Wholesale Price (AWP): Generic = $7,718 | Brand = $8,124